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Date Job Title Job Level Location
9/19/20 Product Strategy Leader Individual contributor South San Francisco, California

PRODUCT STRATEGY LEADER

With patients’ health and well-being depending on the reliable supply of high-quality medicines, effective Product Lifecycle Management of Roche’s portfolio of therapeutic products is crucial. Our organization, Technical Product Management and Network Strategy (TPM), is responsible for delivery of end-to-end product and network strategy to ensure faster supply to more patients. Our leaders sit between development, manufacturing, supply chain and commercial global functions and markets providing a unique view to the full industrialization and commercialization of our portfolio. Through leadership and partnerships, we ensure execution of Roche enterprise supply strategy by developing and managing a portfolio and network view.

We are looking for a Product Strategy Leader (PSL) to join our team. In this role you will be accountable for commercial launch and technical lifecycle management of assigned product(s). You will own the end-to-end product strategy and execution focusing on the largest value driving stages of the product life cycle, from commercial launch through the resilient stage, and preparing the product to be fully established. As a leader in this organization you will be the Pharma Global Technical Operations (PT) “Voice of the Product” translating the business drivers for the product and external trends and insights into robust supply chain lifecycle plans that enable patient access and product value. 

In addition, your responsibilities will be:

  • Design the end-to-end supply chains for the full product lifecycle, translating business strategy and lifecycle vision into the PT plan for execution. 
  • Set “Best in Class” supply chain performance targets across the product lifecycle, ensuring long term execution is on track to deliver the commercial ambition for the product (e.g. cost, format focused on customer need, access for patient reach). 
  • Drive decisions from a whole system and portfolio perspective to make best use of resources and drive the highest value. Understand and articulate key drivers, interdependencies, and implications emerging from strategic decisions.
  • Create Product Books to align the organization with the lifecycle strategy. Translate external insights, competitive landscape and commercial objectives into agreed financial, operational and project objectives that optimize product performance. 
  • Effectively manage holistic end-to-end strategic risk through the product lifecycle, ensuring robustness and resiliency by proactively addressing supply, product or compliance risks
  • Actively support the Long Range Planning (LRP) probabilistic forecasting, ensuring an enterprise strategy that considers product and network implications.
  • Develop scenarios and prepare options for the supply chain to respond to upside and downside of commercial forecasts.
  • Lead and manage global matrixed Technical Product Teams (TPTs) for PT, including members across the following functions: Development, Supply Chain, Quality, Technical Regulatory, Finance & Manufacturing.
  • Represent PT voice on the Product Lifecycle teams, driving teamwork between TPTs, PT, GPS and Pharma
  • Embrace and employ Lean Production System and Agile methodologies including lean leadership, continuous improvement, rapid experimentation, and iteration. 
  • Enable teams to shape product strategy through engagement of customers and stakeholders. Approach problems and co-create solutions across PT and GPS
  • Inspire and lead others to communicate and act with a clear vision and purpose, connecting different perspectives; Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.

In order to be successful in this position, you should have:

  • BS / MS Degree (life sciences, engineering and/or business disciplines preferred)
  • 10 years of multi-disciplinary work experience in the Pharma / Biotech industry. 15+ years preferred. 
  • Knowledge of various manufacturing processes and platforms, and the relevant GMP quality and regulatory dependencies 
  • Business Acumen and Problem-solving skills that you are able to apply within a supply chain context
  • 7 or more years’ previous senior people management or senior matrix team leadership experience. 10+ years preferred.
  • Deep understanding of the pharmaceutical commercial markets and process development
  • Ability to effectively handle ambiguity and uncertainty
  • Proven ability to build trustful and effective relationships
  • Able to think strategically and translate strategies into actionable plans
  • Strong verbal and written communication skills and the ability to influence at all levels
  • International / global experience is strongly preferred.
  • Able to travel globally

#LI-DL1

#ptcareers

9/18/20 Senior Facility Coordinator Individual contributor Hillsboro, Oregon

The individual hired for this position will be a part of the Security team and will assist with the completion of Genentech’s Hillsboro, Oregon site Security goals and objectives. This will include the development and implementation of Security programs, the initiation and completion of improvement projects, in addition to assisting with the resolution of Security concerns from our manufacturing customers. This position reports to the Associate Director Security.

 

Responsibilities:

  Owns and implements the Fire Life Safety and Transportation Security Administration Certified Cargo Screening Programs. Responsible for sharing best practices and helping to implement the Fire Life Safety program at other sites

  Perform and guide activities related to all site Security programs including the Disruption Access Request (DAR), CCure Administration, Key Inventory, Morse Watchman, Capital Asset Tracking, X-Ray Machine Preventative Maintenance

• Communicate effectively with our customers employing the ability to present ideas well one on one, in small groups, and to larger audiences

• Effectively influence others to take action to mitigate Security risks

• Assist in the investigation of Security incidents and the development of corrective actions

• Apply the hierarchy of controls to reduce Security risks and strengthen compliance

• Provide Security assistance and guidance to security committees, including Security regulatory interpretations

• Provide Security support in the design and installation of new or modified equipment and management of change processes

  Develop and revise training content and present Security and Emergency Response training to plant employees

  Assist in management of the site Emergency Management System

 

Minimum Qualifications:

• High School Diploma or equivalent

• Minimum of five years of Security experience in manufacturing and/or operating within a robust Security operation

• Experience with implementing and or managing a fire life safety system including wet and dry preventative maintenance systems

• Team player

• Strong computer skills

Preferred Qualifications:

• Bachelor's degree

• Experience with local, state and federal regulations

• Experience conducting hazard/risk assessments in a manufacturing environment

  Strong analytical and problem-solving skills, able to multi-task and develop practical solutions for a variety of complex problems

  ISO28000 Lead Auditor Certification

  Professional certification as a Certified Protection Professional (CPP) desired

9/18/20 Technical Specialist / Engineer (2 Positions) Individual contributor South San Francisco, California

The Technical Specialist / Engineer is an integral member of the Clinical Supply Center (CSC) team, in South San Francisco (SSF). The SSF CSC is designed to be a state-of-the-art large molecule drug substance facility which supports GMP production for phase 1, 2 and early phase 3 clinical trials. The CSC will employ a ballroom design, utilize single-use technology, new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility. We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset.  Ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual.  Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production.

While this posting is open to all applicants, preference will be given to individuals familiar with South San Francisco Clinical and Commercial Technical Operations experience (or equivalent technology, process and operations). This position can be performed remotely for the next approximately 3 months, however will gradually transition to require at least partial on-site presence in order to perform the essential project and operational responsibilities of the role. As we transition to “normal” the option to work flexibly should be available as appropriate given business needs and with management endorsement

In this role the qualified individual will be part of the Operations, Process Support and Process Engineering  team that starts up the facility. There will be one team that will support the entire process from initial cell bank thaw through bulk freeze. Team members will support manufacturing operations upstream and downstream but will also have responsibility for technical evaluations, troubleshooting, and work with vendors on equipment or consumable design. The candidate will engage with customer groups, network teams and vendors seeking opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions. 

Responsibilities:

  • Technical contact for team, customers and vendors to consult with on new technologies and troubleshooting efforts

  • Support troubleshooting efforts on equipment in support of release of drug substance material

  • Initiate and lead projects that result in implementation and/or optimization of novel methods and techniques

  • Ability to work with minimal oversight 

  • Support effective partnerships within & outside of Roche

  • Contributes to achieving results in other organizations across the company

  • Member of functional, organizational and cross functional teams/projects

  • Enhances safety of the organization through process/equipment improvements

  • Equipment maintenance, design and purchase

  • Give speaker presentations across departments

Skills and Behavior Profile:

  • Strong behaviors aligned with Pharma Technical (PT) expectations specifically: Lean/Agile, inclusion, collaboration, speaking up, decision making and continuous improvement

  • Ability to work in an agile and ambiguous environment

  • Commitment to quality and excellence

  • Growth mindset with a passion for taking on challenges in order to deliver business value while developing

  • Entrepreneurial spirit within a GMP environment

  • Ability to challenge the status quo in order to deliver value



 

Qualifications:

  • BA/BS in a life science, engineering or equivalent, with at least eight years of relevant work experience

  • Understand current GMP requirements and regulations

  • Extensive practical and theoretical expertise in biopharmaceutical manufacturing processes and process development. 

  • Ability to work in fast paced dynamic work environment

  • Ability to keep clear and accurate records of work

  • Possess excellent interpersonal and communication skills

  • Strong problem solving and critical thinking skills

  • Self-motivated, organized and capable of multitasking

#ptd

#ptcareers

#LI-DW1

9/18/20 Senior Technical Specialist / Engineer (2 Positions) Individual contributor South San Francisco, California

The Senior Technical Specialist / Engineer is an integral member of the Clinical Supply Center team based in South San Francisco. The SSF CSC is designed to be a state-of-the-art large molecule drug substance facility which supports GMP production for phase 1, 2 and early phase 3 clinical trials. The CSC will employ a ballroom design, utilize single-use technology, new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility. We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong PT Behaviors,  and have an agile mindset. Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production. 

While this posting is open to all applicants, preference will be given to individuals familiar with South San Francisco Clinical and Commercial Technical Operations experience (or equivalent technology, process and operations). This position can be performed remotely for the next approximately 3 months, however will gradually transition to require at least partial on-site presence in order to perform the essential project and operational responsibilities of the role. As we transition to “normal” the option to work flexibly should be available as appropriate given business needs and with management endorsement.

In this role the qualified individual will be part of the Operations team that starts up the facility. There will be one Operations team that will support the entire process from initial cell bank thaw through bulk freeze. Team members will support manufacturing operations upstream and downstream but will also have responsibility for technical evaluations, troubleshooting, and work with vendors on equipment or consumable design. They will mentor junior staff and serve as a consultant in troubleshooting efforts. The candidate will establish relationships with customer groups, network teams and vendors by seeking opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions. While there are common expectations for team members in this role, it  may be required for individuals to focus on equipment systems and technology either upstream or downstream, support of consumable designs and sustainability, as well as SOP and training standards.

Responsibilities:

  • Technical leader for team, customers and vendors to consult with on new technologies and troubleshooting efforts 

  • Lead complicated troubleshooting efforts on equipment in support of release of drug substance material

  • Initiate and lead projects that result in implementation and/or optimization of novel methods and techniques

  • Ability to work with minimal oversight and may be responsible for managing interns, co-ops and direct reports

  • Applies technical expertise to propose and lead strategic technology improvements in the facility and across the network

  • Creates effective partnerships within & outside of Roche

  • Contributes to achieving results in other organizations across the company

  • Lead functional, organizational and cross functional teams/projects

  • Enhances safety of the organization through process/equipment improvements

  • Equipment maintenance, design and purchase

  • Give speaker presentations across departments, to senior management & at national meetings

  • Writes  and/or contributes to external publications

Skills and Behavior Profile:

●  Strong behaviors aligned with Pharma Technical (PT) expectations including Lean/Agile, inclusion, collaboration, speaking up, decision making and continuous improvement

●  Ability to work in an agile and ambiguous environment

●  Commitment to quality and excellence

●  Growth mindset with a passion for taking on challenges in order to deliver business value while developing

●  Entrepreneurial spirit within a GMP environment

●  Servant leader with strong coaching skills

●  Ability to challenge the status quo in order to deliver value

Qualifications:

  • BA/BS in a life science or equivalent, with at least eight years of relevant work experience

  • Understand current GMP requirements and regulations

  • Extensive practical and theoretical expertise in biopharmaceutical manufacturing processes and process development. 

  • Strong technical leader who can work with team of diverse skills and objectives

  • Ability to initiate, form and lead teams or projects 

  • Possess excellent interpersonal and communication skills





 

#ptd

#ptcareers

#LI-DW1

  

9/18/20 Senior / Principal Automation Engineer Individual contributor South San Francisco, California

The Senior / Principal Automation Engineer is an integral member of Clinical Supply Center (CSC) team, in South San Francisco (SSF). The SSF CSC is designed to be a state-of-the-art large molecule drug substance facility which supports GMP production for phase 1, 2 and early phase 3 clinical trials. The CSC will employ a ballroom design, utilize single-use technology, new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility. We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset.  Ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual.  Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production. 

In this role, the qualified individual will initially be part of the CSC project team that designs, delivers, and starts up the automation systems in the facility and will then transition to operational support of the facility.  The candidate will establish relationships with customer groups, network teams and vendors by seeking opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions.  More than one individual may be selected under this overall job description.  Candidates are initially expected to have E4/E5 level expertise in either Automation or Integration and will develop additional expertise over time through a combination of role assignments and coaching. The final level for a successful candidate will be based on their demonstrated skills, experience, and capabilities.

While this posting is open to all applicants, preference will be given to individuals familiar with South San Francisco Clinical and Commercial Technical Operations (or equivalent technology, process and operations). This position can be performed remotely for the next approximately 6-9 months, however will gradually transition to require at least partial on-site presence in order to perform the essential project and operational responsibilities of the role. As we transition to “normal” the option to work flexibly should be available as appropriate given business needs and with management endorsement.

Responsibilities:

The CSC Senior/Principal Automation Engineer provides subject matter expertise and technical leadership of the Automation or Integration design, evaluates design prototypes and alternatives, and is responsible for the successful implementation and start-up of the CSC automation.  The role will continue into a system management/ownership and support role where the responsibilities include ongoing system lifecycle strategy, planning and management of the automation system(s) after project delivery and GMP startup. 

In the operational role the CSC Senior/Principle Engineer will coordinate and participate in all activities required to support production.  They will also provide ongoing system ownership and continuous improvement leveraging automation systems to add more value for patients over time.  The CSC Senior/Principle Engineer will also drive Automation and IT innovation, and partner with operations to provide high value solutions to technical challenges.  There is an expectation that the CSC Senior/Principle Engineer will continue to expand expertise in emerging technologies such as machine learning, data analytics and robotics.  As a senior technical expert the CSC Senior/Principle Engineer is expected to challenge the status-quo and develop creative solutions within the framework of the Global Standards and processes.  The CSC Senior/Principle Engineer partners proactively with key customers, while being open and approachable with a friendly, positive and professional attitude.

This position requires strong adherence to compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents.  .  As with any position in a manufacturing environment, the job requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.

Skills and Behavior Profile:

  • Strong PT behaviors, with an emphasis on continuous improvement
  • Ability to work in an agile and ambiguous environment
  • Commitment to quality
  • Growth mindset
  • Entrepreneurial spirit within a GMP environment
  • Servant leader with strong coaching skills

Qualifications:

  • B.S. Degree in Engineering or related discipline with 12 to 15 years of experience in pharmaceutical/biotech (10 to 13 years of experience with Master’s Degree)
  • Ability to execute complex automation projects in a GMP environment.
  • Understand current GMP requirements and regulations
  • Strong strategic thinker
  • Possess excellent interpersonal and communication skills
  • Strong problem solving and critical thinking skills

#ptd

#ptcareers

#LI-DW1

9/18/20 Senior / Principal Automation Engineer - IT Infrastructure Individual contributor South San Francisco, California

The Senior/ Principal Automation Engineer - IT Infrastructure is an integral member of Clinical Supply Center (CSC) team, in South San Francisco (SSF). The SSF CSC is designed to be a state-of-the-art large molecule drug substance facility which supports GMP production for phase 1, 2 and early phase 3 clinical trials. The CSC will employ a ballroom design, utilize single-use technology, new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility. We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset.  Ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual.  Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production. 

In this role, the qualified individual will initially be part of the CSC project team that designs, delivers, and starts up the automation systems in the facility and will then transition to operational support of the facility.  The candidate will establish relationships with customer groups, network teams and vendors by seeking opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions.  Candidates are initially expected to have E4/E5 level expertise in IT Infrastructure and will develop additional expertise over time through a combination of role assignments and coaching. The final level for a successful candidate will be based on their demonstrated skills, experience, and capabilities.

While this posting is open to all applicants, preference will be given to individuals familiar with South San Francisco Clinical and Commercial Technical Operations experience (or equivalent technology, process and operations). This position can be performed remotely for the next approximately 6-9 months, however will gradually transition to require at least partial on-site presence in order to perform the essential project and operational responsibilities of the role. As we transition to “normal” the option to work flexibly should be available as appropriate given business needs and with management endorsement.

Responsibilities:

The CSC Senior/Principal Automation Engineer provides subject matter expertise and technical leadership of the IT Infrastructure design, evaluates design prototypes and alternatives, and is responsible for the successful implementation and start-up of the CSC automation and IT system(s).  The role will continue into a system management/ownership and support role where the responsibilities include ongoing system lifecycle strategy, planning and management of the infrastructure system(s) after project delivery and GMP startup. 

In the operational role the CSC Senior/Principle Engineer will coordinate and participate in all activities required to support production.  They will also provide ongoing system ownership and continuous improvement leveraging automation systems to add more value for patients over time.  The CSC Senior/Principle Engineer will also drive Automation and IT innovation, and partner with operations to provide high value solutions to technical challenges.  There is an expectation that the CSC Senior/Principle Engineer will continue to expand expertise in emerging technologies such as machine learning, data analytics and robotics.  As a senior technical expert the CSC Senior/Principle Engineer is expected to challenge the status-quo and develop creative solutions within the framework of the Global Standards and processes.  The CSC Senior/Principle Engineer partners proactively with key customers, while being open and approachable with a friendly, positive and professional attitude.

This position requires strong adherence to compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents.  .  As with any position in a manufacturing environment, the job requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.

Skills and Behavior Profile:

  • Strong PT behaviors, with an emphasis on continuous improvement
  • Ability to work in an agile and ambiguous environment
  • Commitment to quality
  • Growth mindset
  • Entrepreneurial spirit within a GMP environment
  • Servant leader with strong coaching skills

Qualifications:

  • B.S. Degree in Engineering or related discipline with 12 to 15 years of experience in pharmaceutical/biotech (10 to 13 years of experience with Master’s Degree)
  • Ability to execute complex automation projects in a GMP environment.
  • Understand current GMP requirements and regulations
  • Strong strategic thinker
  • Possess excellent interpersonal and communication skills
  • Strong problem solving and critical thinking skills

#ptd

#ptcareers

#LI-DW1

9/18/20 Senior / Principal Process Equipment Engineer (2 positions) Individual contributor South San Francisco, California

The Senior/Principal Process Equipment Engineer is an integral member of the Clinical Supply Center (CSC) team in South San Francisco (SSF).  The SSF CSC is designed to be a state-of-the-art large molecule drug substance facility which supports GMP production for phase 1, 2 and early phase 3 clinical trials. The CSC will employ a ballroom design, utilize single-use technology, new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility.  We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset.  Ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual.  Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production. 

In this role the qualified individual will initially be part of the CSC project team that designs, delivers and starts up the facility and will then transition to a Process Equipment/Project Manager/Validation Engineer role in support of the facility.  The candidate will establish relationships with customer groups, network teams and vendors by seeking opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions.  More than one individual may be selected under this overall job description. Candidates are initially expected to have E4/E5 level expertise in either Process Equipment, Project Management or Validation Engineering and will develop additional expertise over time through a combination of role assignments and coaching. The final level for a successful candidate will be based on their demonstrated skills, experience, and capabilities.

While this posting is open to all applicants, preference will be given to individuals familiar with South San Francisco Clinical and Commercial Technical Operations (or equivalent technology, process and operations). This position can be performed remotely for the next approximately 6-9 months, however will gradually transition to require at least partial on-site presence in order to perform the essential project and operational responsibilities of the role. As we transition to “normal” the option to work flexibly should be available as appropriate given business needs and with management endorsement.

Responsibilities:

The CSC Senior/Principal Process Equipment Engineer provides subject matter expertise and technical leadership for the CSC Project design, qualification and start-up of process equipment, utilities and facilities.  CSC Senior/Principal Process Equipment Engineer may develop and manage a comprehensive plant startup, commissioning and qualification project plan and schedule.  May lead regular huddles to coordinate activities and ensure all resources are aligned to complete planned activities and problem solve to ensure success when unexpected events arise.  The CSC Senior/Principal Process Equipment Engineer may champion and inspire alignment with network Single Use Equipment Standards.  May collaborate with network Biomanufacturing for the Future Team (BM4T) to initiate and evaluate new technologies, new vendors or new equipment offerings.   The assigned project role will be dependent on the immediate project needs and the selected candidate’s expertise.

The role will continue into an operational Process Equipment/Project Manager/Validation Engineer role where the responsibilities may include ongoing system lifecycle strategy, design, project management and qualification of capital investments, program management for innovation and plant investment strategy, and definition of engineering processes and standards.  In the operational role the CSC Senior/Principle Engineer will coordinate and participate in all activities required to support production.  They will also provide ongoing system ownership and continuous improvement leveraging design choices and execution models to add more value for patients over time.  The CSC Senior/Principle Engineer will also drive Equipment, Facility, Utility and Single Use Assembly innovation and partner with operations to provide high value solutions to technical challenges.  There is an expectation that the CSC Senior/Principle Engineer will continue to expand expertise in emerging technologies by establishing and maintaining relationships with equipment suppliers, driving proof of concept evaluations and pilot implementations.  As a senior technical expert the CSC Senior/Principle Engineer is expected to challenge the status-quo and develop creative solutions within the framework of the Global Standards and processes.  The CSC Senior/Principle Engineer partners proactively with key customers while being open and approachable with a friendly, positive and professional attitude.

This position requires strong adherence to compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents.  .  As with any position in a manufacturing environment, the job requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.

Skills and Behavior Profile:

  • Strong behaviors aligned with Pharma Technical (PT) expectations including Lean/Agile, inclusion, collaboration, speaking up, decision making and continuous improvement
  • Ability to work in an agile and ambiguous environment
  • Commitment to quality and excellence
  • Growth mindset with a passion for taking on challenges in order to deliver business value while developing
  • Entrepreneurial spirit within a GMP environment
  • Servant leader with strong coaching skills
  • Ability to challenge the status quo in order to deliver value

Qualifications:

  • B.S. Degree in Engineering or related discipline with 12 to 15 years of experience in pharmaceutical/biotech (10 to 13 years of experience with Master’s Degree)
  • Ability to execute complex projects in a GMP environment.
  • Understand current GMP requirements and regulations
  • Strong strategic thinker
  • Possess excellent interpersonal and communication skills
  • Strong problem solving and critical thinking skills

#ptd

#ptcareers

#LI-DW1

9/18/20 Automation Engineer II / Senior Engineer - Data Tools Individual contributor South San Francisco, California

The CSC Automation Engineer II / Senior Engineer – Data Tools is an integral member of Clinical Supply Center (CSC) team, in South San Francisco (SSF). The SSF CSC is designed to be a state-of-the-art large molecule drug substance facility which supports GMP production for phase 1, 2 and early phase 3 clinical trials. The CSC will employ a ballroom design, utilize single-use technology, new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility. We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset.  Ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual.  Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production. 

In this role, the qualified individual will initially be part of the CSC project team that designs, delivers, and starts up the automation systems in the facility and will then transition to operational support of the facility.  The candidate will establish relationships with customer groups, network teams and vendors by seeking opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions.  Candidates are initially expected to have E3/E4 level expertise in data tools, data analytics or recipe authoring design and will develop additional expertise over time through a combination of role assignments and coaching. The final level for a successful candidate will be based on their demonstrated skills, experience, and capabilities.

While this posting is open to all applicants, preference will be given to individuals familiar with South San Francisco Clinical and Commercial Technical Operations experience (or equivalent technology, process and operations). This position can be performed remotely for the next approximately 6-9 months, however will gradually transition to require at least partial on-site presence in order to perform the essential project and operational responsibilities of the role. As we transition to “normal” the option to work flexibly should be available as appropriate given business needs and with management endorsement.

Responsibilities:

The CSC Engineer II / Senior Automation Engineer provides emerging subject matter expertise and technical leadership of the Automation data tools, data analytics or Recipe Author design, evaluates design prototypes and alternatives, and is responsible for the successful implementation and start-up of the CSC automation.  The role will continue into a system management/ownership and support role where the responsibilities include ongoing system lifecycle strategy, planning and management of the automation system(s) after project delivery and GMP startup. 

In the operational role the CSC Engineer II / Senior Engineer will coordinate and participate in all activities required to support production.  They will also provide ongoing system ownership and continuous improvement leveraging automation systems to add more value for patients over time.  The CSC Engineer II / Senior Engineer will also drive Automation innovation, and partner with operations to provide high value solutions to technical challenges.  There is an expectation that the CSC Engineer II/Senior Engineer will continue to expand expertise in emerging technologies such as machine learning, data analytics and robotics.  As an emerging technical expert the CSC Engineer II/Senior Engineer is expected to identify opportunities to challenge the status-quo and develop creative solutions within the framework of the Global Standards and processes.  The CSC Engineer II/Senior Engineer partners proactively with key customers, while being open and approachable with a friendly, positive and professional attitude.

This position requires strong adherence to compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents.  .  As with any position in a manufacturing environment, the job requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.

Skills and Behavior Profile:

  • Strong PT behaviors, with an emphasis on continuous improvement
  • Ability to work in an agile and ambiguous environment
  • Commitment to quality
  • Growth mindset
  • Entrepreneurial spirit within a GMP environment
  • Servant leader with strong coaching skills

Qualifications:

  • B.S. Degree in Engineering or related discipline with 8 to 12 years of experience in pharmaceutical/biotech (6 to 10 years of experience with Master’s Degree)
  • Ability to execute complex automation projects in a GMP environment.
  • Understand current GMP requirements and regulations
  • Emerging strategic thinker
  • Possess excellent interpersonal and communication skills
  • Strong problem solving and critical thinking skills

#ptd

#ptcareers

#LI-DW1

9/18/20 End User Workplace Technology Specialist Individual contributor South San Francisco, California

This role is for a high performance individual with a passion for end user technology.  Primary duties focus on evaluating and recommending new end user technologies and services.  Align customer requirements to IT capabilities.  Develop and build custom services when existing technologies do not meet business requirements.  Work with a diverse global team of business and IT personnel to develop new ways of working. Can independently make decisions that impact the project level and influence decision makers. Acts as team lead overseeing the work of other team members and able to represent managers in meetings making decisions relating to areas of subject matter expertise.

Responsibilities:

  • Work with a large global team to establish user standards for various end user workplace technologies. 

  • Monitor and evaluate technology and service trends for end user capabilities.

  • Partner with and influence global teams in building strategic roadmaps.

  • Work as the technical SME on implementation projects.

  • Virtual/Augmented/Mixed Reality technology evaluations and support.

  • Drive efficiency by utilizing globally defined best practice processes for End User Workplace.

  • Maintain and support the Workplace Technology estate to the approved global hardware standards utilizing agreed Global Images, processes, procedures and workflows including security controls.

  • Adhere to agreed SLAs and metrics utilizing the ITSM platform (ServiceNow).

  • Assist in the identification, implementation and, where needed, documentation of remediation activities.

  • Input into Continuous Service Improvement for delivery of services, including process enhancements, Knowledge Base articles, and user training material.

  • Build and maintain strong relationships and awareness with team and cross functional IT colleagues, business colleagues and key stakeholders.

  • Support of Real Estate activities, including colleague moves, office relocations, integrations and closures.

  • Provide value-added service through Senior Leadership Support, when required.

  • Provide user training and guidance through various methods, including face to face and group sessions.

  • Act as conduit between WEX (Workplace Employee Experience) and Onsite User Services with regard to projects and digitalization efforts 

  • Act as a lead influencer of innovation, optimization, and process improvement within the User Services organization and beyond

  • Use data, feedback, and ingenuity to drive better service, products, processes, and support procedures.

  • Evaluate, analyze, scope, recommend, maintain, and support platforms and applications that help usher users toward increased self-service.

  • Suggest, lead, and contribute to innovative solutions, proof of concepts, pilots, and new support channels.

  • Develop an intake/prioritization process for incoming work requests based on the business impact and level of effort required.

  • Proactively identify, investigate, resolve, and prevent complex technical incidents and problems.

  • Develop and test customized solutions to meet specific business needs.

  • Act as a technical project lead - assist with deploying new projects, collaborate closely with Service Transition Managers, PMs, and other global/local resources. 

  • Organize the necessary technical knowledge, resources, and support from the business to implement global solutions locally and bridge existing gaps along the way.

  • Follow Agile project management methodologies (in terms of delivery/support of projects).

Qualifications: 

  • Minimum of 5 years of related experience. 

  • Appropriate certifications for desktop and applications support.

  • Outstanding customer service and interpersonal skills. 

  • Proven ability to work in a team environment. 

  • Demonstrated skills in developing technical solutions to a wide range of difficult problems Solutions are imaginative, thorough, practicable, and consistent with organization objectives. Skilled in root-cause analysis. 

  • Communicate clearly with technical and non-technical audiences, both verbally and written. Demonstrated communication and interpersonal skills (oral, written, telephone) including diplomacy, tact, and flexibility to interact effectively and respond to employees and outside contractors with technical and non-technical problems.

  • Strong organizational skills and ability to prioritize tasks among many competing requests. 

  • Experience supporting mission-critical production systems in an enterprise environment.

  •  Ability to prioritize, plan and report status at the project level. Can frame approaches and timelines for project work, skilled at setting priorities to complete tasks / projects within scheduled time frame 

  • Strong analytical skills for effective troubleshooting and problem solving.

  • Ability to encourage others in fostering effective teamwork and actively solicits ideas from others. 

  • Can lead small projects and mentor/lead individuals in workgroup. Plays lead role responsible for key deliverables (on behalf of multiple resources) on projects. Represents workgroup on project teams and influences the decisions and direction of project. Serves as the “go to” resource for the work group or project team. 

  • Determine methods and procedures on new assignments and coordinate activities of others in a technical lead role. 

  • College Degree in the field of computer science, information sciences, or related field preferred.

  • Experience working directly with user/customer base, with ability to have a positive impact on activities from a distance.

  • Contribute to a Global, team-oriented, collaborative workplace.

  • Strong verbal and written communication skills with an ability to present ideas in non-technical language.

  • Self-Motivated with an ability to effectively prioritize and execute tasks in a high-pressure environment.

  • Ability to work in an agile and dynamic manner.

  • Strong knowledge of End User Workplace environment setup and maintenance.

  • Has acted as the technical lead for multiple projects, implementations, upgrades, deployments and/or migrations.

  • Advanced technical experience supporting Windows OS, Macintosh OSX, virtual environments, & iOS devices.

  • Relevant Certifications preferred.

  • Detailed understanding of, and experience with, the following are a plus: automation, scripting languages, data analysis, digital experience management, deployments, cloud-based platforms, information security management, SCCM, JAMF, desktop infrastructure, software packaging and distribution, patch management, digital workplace environments, machine learning, artificial intelligence, etc.

  • Well-versed in ITIL core processes:  Incident Management (IM), Request Management (RM), and Knowledge Management (KM).

  • Business travel may occasionally be required.

#ITcareers

#LI-PK1

9/18/20 Project Coordinator / Lab Analyst – Process Validation Analytical Operations Individual contributor South San Francisco, California

Note:

  • This role may be filled at the Associate Project Coordinator or Project Coordinator level.
  • We are only considering San Francisco Bay Area candidates.  No relocation support is available for this role.

 

RESPONSIBILITIES: 

This is a hybrid project coordinator and lab analyst position. The position will coordinate Process Validation (PV) study samples, documentation and results and join the assay scheduling team in Analytical Operations (AO). It will also support analytical testing by executing and documenting methods per test procedure returning quality data and participating in lab maintenance.

 

Process Validation in Analytical Operations (PVAO) is a part of AO in Pharma Technical Development (PTD). AO provides analytical support for process development enabling informed and timely process decisions. AO develops and runs a wide variety of technologies including lab automation, ELISAs, UHPLC and mass spectrometry supporting PTD from Stage A through D and E.

PVAO coordinates analytical testing in support of PV studies, technology transfers, and investigations for Stage D and post-approval molecules across the Roche network. Project Coordinators manage sample coordination, data and documentation in a compliant environment tracking metrics and maintaining business systems.

 

Specific job duties/responsibilities include: handling of biological and chemical reagents, following study protocols, preparing samples, scheduling testing, communicating study status to stakeholders, overseeing the quality and compliance of the work, executing assays per test procedure, assay and lab maintenance, presenting in formal settings, and writing summary reports.

 

The individual will be required to work independently as well as in a team environment within AO and with analytical groups, technical teams, quality, BioProcess groups, and external contacts for contract manufacturing facilities or satellite Genentech facilities. They will communicate effectively with all levels of the organization. The individual will be expected to follow applicable procedures, quality standards and policies, and comply with industry guidelines.

 

 

REQUIREMENTS:

 

Bachelor's degree in Biological Sciences field with a minimum of 1-2 years of laboratory experience in biotechnology area. Requires initiative, attention to detail and a desire to deliver high quality work.  Must be able to manage multiple projects simultaneously and accommodate shifting priorities and timelines. Must be willing to support analytical testing and project coordination.

 

Additional requirements include: strong written and verbal communication, good organization, multi-tasking and problem-solving skills, familiarity and knowledge of cGMP’s and compliance. Knowledge of analytical methodologies (ELISAs, UHPLC, or others) is also desirable.

 

Proficiency in Microsoft Word and Excel is necessary. Experience with Electronic Lab Notebooks (ELN), LIMS, databases and programming, experience running analytical assays such as ELISA and HPLC, and project management experience are pluses.

#ptd

#ptcareers

9/17/20 Service Lead, Digital Relationship Management (RM) Individual contributor South San Francisco, California

Purpose  

Digital Customer Experience (DCX) is a functional group within Genentech Business Operations (GBO) comprised of digital experts who partner across Commercial, Medical Affairs and Government Affairs (CMG) to orchestrate and deliver integrated digital customer experiences that drive measurable business outcomes.

The DCX Relationship Management (RM) Service Lead will be the work product owner of Relationship Management services within DCX. They are broadly responsible for ensuring that the relationship management strategies and capabilities of DCX are accelerating the organization’s progress towards delivering great customer experiences. 

This individual also lives the CMG Operating Principles (I put the patient first always; I am tenacious in meeting customer needs; I act on behalf of the whole company, not just my own team; I am accountable; I use time and resources to create the most impact; I am inclusive; I have a bias for action; I build a culture of trust; My career will thrive as I grow my capabilities and increase my impact; I act with integrity).

Key Responsibilities

Maximizing Business Outcomes

  • Is the work product owner of DCX RM services and is responsible for the overall vision and success of Relationship Management
  • Synthesize customer and business trends to identify short-term and long-term opportunities for the DCX RM Service
  • Develop and execute capabilities roadmaps that allow the DCX RM service to advance customer experiences and campaign performance
  • Define and lead DCX RM work products using agile methodology to achieve 90 day business priorities and customer strategies
  • Is an active member of the DCX leadership team and plays a key role in shaping a performance-driven culture

DCX and CMG influence

  • Consult, participate and lead CMG work products requiring Relationship Management expertise
  • Collaborate across DCX service teams to achieve business and customer goals
  • Ensure CMG leaders are clear on value proposition of Relationship Management and how it can be leveraged to achieve business and customer goals

Resource planning and Management

  • Accountable for overall resourcing strategy for the DCX RM service including offshoring
  • Overall budget management for the DCX RM service
  • Lead contracting strategies for DCX RM-specific vendors
  • Responsible for service team culture and operating principles
  • Coaches and advises service team members on CMG operating principles
  • Develops a team culture of accountability and adaptability
  • Develops change leadership strategies in support of service evolution

Skills & Competencies

  • Broad expertise in all aspects of relationship management with an emphasis on digital relationship management – campaign planning, email, marketing automation, Customer Relationship Management (CRM), customer experience (CX)  privacy
  • Growth mindset, looking to continually learn and build expertise
  • Expertise in digital marketing
  • Ability to think with an enterprise mindset
  • Experience with change leadership
  • Ability to influence and inspire individuals across the CMG network, from front-line employees to executives
  • Strong drive for results through agile planning and execution
  • Ability to create capabilities plans and design fit-for-purpose solutions
  • Budget and finance management
  • Strong customer orientation and mindset
  • Goal oriented, ability to clearly define success and relevant Key Performance Indicators

Qualifications & Experience

  • Bachelor's degree required, MBA or other related graduate level degree preferred
  • 12-15 years of experience across varying roles with significant time in digital marketing, customer relationship management
  • Experience in the managed care, pharmaceutical or biotech industry
  • Experience leading teams

#LI-KG1

9/17/20 Clinical Program Leader Individual contributor South San Francisco, California

  • Contribute to the development of the IDCP and medical plans and establish the operational plan for a new program or study including scenario planning, high level forecasting of timelines, assessment of program level feasibility, estimation of resources and budget based on benchmarks, and development of high level operational strategies. Review the operational plan with USMA EG Clinical Operations Leadership for alignment within the therapeutic area. Communicate initial budget, timelines, and changes to appropriate review bodies and to the assigned Clinical Trial Leader (CTL).
  • Provide clear and concise recommendations based upon function review and expertise at SOURCe (advisory committee for USMA squad medical partners/Study Work Product Teams) for assigned programs; gain alignment with functional management ahead of SOURCe meeting and address any action items and submit any follow-up documents required by SOURCe, as needed.
  • Make broad contribution at strategic level including input into risk management plans, business value assessment and therapeutic area/indication expertise.
  • Provide innovative and flexible operational solutions and options for the IDCP.
  • Provide disease area expertise and input to the function and TA, medical team and squad, as appropriate.
  • Accountable for meeting all operational deliverables in accordance with time, cost and quality commitments. Maintain an overview of status, issues, and proactively communicate progress, issues or changes that may impact timelines and costs of the program to all stakeholders including Clinical Operations Leadership. Maintain internal consistency across studies within a program.
  • Collaborate effectively with internal and external partners (ie: Ad Boards, Advocacy groups, Steering Committees, TAEs); ensure alignment of operational program to the medical team’s goals.
  • Provide program leadership to study teams by providing program specific guidance, clinical trial management expertise, operational strategies, and direction to achieve results. Mentors and coaches USMA staff. Provide timely feedback to managers regarding staffing needs and individual performance in the program.
  • May be assigned to one or more complex programs.
  • May represent USMA Clinical Operations or take a leadership/SME role in work product teams (WPTs) and is in general asked to actively contribute to the optimization of existing as well as the development of new processes and tools in USMA.
9/17/20 Assistant MD/Associate MD Individual contributor Shanghai

1.    Cross-Functional Team Membership

  • Participates in the relevant Clinical Science Team (CST)
  • Participates as a standing or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team with cross-functional integration, coordination and alignment  to enable effective and efficient CD plan execution
  • As requested, supports the CST lead and overall team with  training new CST members
  • May also, as appropriate, support relevant sub-teams in training  new team members

2.    Global Clinical Development Planning

  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
  • As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
  • Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, regulatory, business development, commercial operations, legal, etc.
  • Participates in CD strategy development
  • Supports other CST members with development of  clinical science information for inclusion into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)
  • May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science development input and guidance.  Includes reviewing Phase I protocols and providing CD input into these
  • Supports internal partners in transitioning new drugs/indications into Phase IIIB or publication studies.  May review Phase IIIB protocols and other information and provide CD input
  • As assigned, may also consult to pharma partnering on relevant acquisitions, joint ventures or  other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s)
  • Participates in development of  the CD plan for assigned molecule(s)/indication(s) and/or other programs:
    • Gathers and analyzes data and information necessary to create the CD plan
    • Works with other CST members and relevant sub-teams to develop CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)
    • Works with CST and other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the CD plan
  • Supports other CST members in preparing for HA meetings.  As appropriate, participates in HA meetings.  Ethically, effectively and professionally represents the interests of Roche and patients

3.    Clinical Development Plan Implementation

  • Provides clinical support across all relevant studies and programs:
    • Participates in ongoing CST and relevant sub-team meetings, except Global Development Team (GDT), other interactions and communications
    • Designs and develops clinical studies for review and discussion with other CST members
    • May collaborate with others in the development of the product safety profile
    • Collaborates with others in development of clinical sections of investigator brochures, presentations and other materials
    • May participate in the identification and selection of appropriate external investigators and sites
    • May assist others with patient registry design and development (including strategies for patient registry recruitment)
    • Collaborates with others in development of study analytics and data management plans
    • Participates in  investigator and other external presentations, meetings and other communications
    • May support clinical operations, clinical research organizations (CROs), etc. by acting as a point-of-contact for questions, other communications, and interactions
    • Acts as a medical monitor for assigned studies
    • Conducts ongoing reviews of medical/safety data
    • Collaborates with relevant teams and other groups to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve such
    • Supports, as needed, completion of interim study reporting
    • Works closely with other CST members and clinical operations to close-out clinical studies, secure data and complete study reporting
    • Reviews study data to ensure correct medical/scientific data interpretation for interim and final study reporting
    • Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials 
    • Works with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes.  Includes developing label and packaging language, etc.
  • Develops presentations for other CST members to deliver to convey the CD perspective and provide updates on strategies, plans and other activities
  • Works with other CST members in ongoing data generation to address unmet medical needs and identify new or extended CD studies or other programs in the relevant therapeutic area of assignment
  • Completes other special projects, as and when assigned, or otherwise requested 

Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines

9/17/20 Senior Medical Director, Breast and Gynae Manager with direct reports Shanghai

1. Cross-Functional Team Membership

  • Can lead and/or otherwise represents CD in sub-teams (e.g. Study Management Teams)
  • relevant to assigned molecule(s)/indication(s) and helps ensure cross-functional
  • integration, coordination and alignment to enable effective and efficient CD plan execution.
  • Accountable for training new CST members.
  • May also, as appropriate, support relevant sub-teams in assigning and training new team members.
  • As appropriate, participates in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources.
  • Where applicable, may manage one or more direct reports and is, in such instances, responsible for hiring, training, developing and retaining talent on his/her staff.
  • Consistently complies with all governing employment laws, regulations and company HR policies & procedures.

2. Global Clinical Development Planning

  • Maintains the highest standards and levels of scientific and clinical knowledge in clinical oncology.
  • Develops and provides clinical science information for inclusion into the Integrated.
  • Development Commercialization Plan (IDCP), and China assessments on the pre-LIP
  • molecular as part of Development Acceleration deliverables.
  • Represents CD for the assigned molecule(s)/indication(s) to other internal Roche groups.
  • Participates in CD strategy development and may present to various internal committees.
  • Responsible for creating and implementing the CD plan for assigned molecule(s)/indication(s) and/or other programs: 1)Seeks guidance from his/her manager, as and when needed, to ensure appropriate design and development of the CD plan; 2) Responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy, strategic and annual LCPs; 3) Guides CST and relevant sub-teams in developing all CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.); 4) Works with CST and other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the CD plan
  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.
  • Communicates with HAs, as and when needed, or otherwise appropriate. Ethically, effectively and professionally represents the interests of Roche and patients. Escalates matters, as needed, in a timely manner to his/her manager or other internal partners/stakeholders.
  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s).

3. Clinical Development Plan Implementation

  • Provides clinical oversight across all relevant studies and programs:

- Designs and develops clinical studies

- Collaborates with others in the development of the product safety profile

- Collaborates with others in development of clinical sections of investigator brochures, presentations and other materials

- May participate in the identification and selection of appropriate external

investigators and sites

- Guides and collaborates with others on patient registry design and development

(including strategies for patient registry recruitment)

- Acts as CD lead in the development of study analytics and data management

plans for each study

- Represents, alongside his/her manager or others, Roche in key investigator and

other external presentations, meetings and other communications

- Ensures investigators are appropriately and thoroughly briefed, in a timely

manner, on medical/scientific matters relating to each study Acts as a medical

monitor for assigned studies

- Conducts ongoing reviews of medical/safety data

- Collaborates with relevant teams and other groups to measure and monitor study

progress against objectives and plans, including any variances, and proactively

communicate any issues, challenges and potential strategies to resolve such

- Collaborates with other groups to ensure timely and appropriate completion of

interim study reporting

- Collaborates with clinical operations to close-out clinical studies, secure data and

complete study reporting

- Accountable to ensure correct medical/scientific data interpretation for interim

and final study reporting

- Plays a lead role in the development and implementation of communications

strategies to support existing and concluded studies. Includes KOL interactions,

advisory boards, major medical meetings, congresses and other events,

publications and other materials

- Works with regulatory and other internal partners/stakeholders in the completion

and submission of regulatory filings and other regulatory documentation.

Supports others with clinical science information and input for regulatory

submissions and other regulatory processes. Includes developing labeling and

packaging language, etc.

  • Develops and delivers key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities. Includes presenting at advisory boards and other relevant external forums representing Roche.
  • Drives ongoing data generation to address unmet medical needs and recommend new or extended CD studies or other programs to his/her manager and others in the relevant therapeutic area of assignment.
  • Responsible to ensure that CD plans, objectives, and deliverables are consistently accomplished on-time and on-target.
  • Completes and/or leads other special projects, as and when assigned, or otherwise requested.
  • Consistently complies with, and ensures the same among relevant CST members, all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines.

Qualifications & Experience:

  • M.D. with at least 3 years of clinical experience in oncology
  • 3 or more years pharma-industry experience, with focusing on clinical trials.
  • In-depth understanding of Phase II – III drug development, knowledge/understanding of
  • Phase I & IV drug development is a plus
  • Experience authoring a full clinical study protocol is preferred
  • Comprehensive understanding of clinical oncology, understanding/experience on molecular biology is a plus
  • Familiar with competitive activity in oncology
  • Experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
  • Versed in medical aspects of GCP (Good Clinical Practice), ICH (International
  • Conference on Harmonisation of Technical Requirements for Registration of
  • Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations

Abilities:

  • Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values
  • Outstanding attention-to-detail
  • Has sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process. Can effectively contribute to development of disease strategies and plans
  • Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such
  • Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
  • Fluent in English communication
  • Excellent written communication skills
  • Strong business presentation skills: effective at summarizing and presenting the key considerations and decision-points
  • Confident and competent when interacting with varying levels of internal/external management, KOLs, etc.: stays focused and on-point, is able to raise problems or challenges in a productive and mature manner
  • Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
  • Strong orientation to teamwork
9/17/20 Outsourcing Manager / Senior Outsourcing Manager, Discovery Chemistry Individual contributor South San Francisco, California

The Discovery Chemistry department is looking for a highly motivated and talented organic chemist to support our CRO strategy and operations.  The candidate will support our extensive external chemistry efforts that include highly collaborative external teams of over 200 chemists and numerous fee for service synthetic chemistry projects.  Together with our cross-functional teams, the candidate will make major contributions to our small molecule drug discovery projects.  

Major responsibilities would include:

  • Manages synthetic chemistry projects at CROs to support all small molecule drug discovery projects including CRO contracts, budget management, quote management, vendor finance, SOPs and training protocols

  • Scientific lead on multiple simultaneous outsourcing projects including synthetic chemistry trouble-shooting

  • Serves as a key contact to project teams or functions for outsourcing activities

  • Facilitates regular communication between project teams and external outsourcing partners

  • Important contributor to CRO strategy and Genentech-CRO collaboration relationships.  E.g. manages CRO performance, improves operational efficiency, develops new chemistry technology at CROs to support and enable our project chemistry.

Required Qualifications:

  • PhD degree in organic chemistry with 2 years of post-graduate synthetic chemistry experience or BS/MS degree with equivalent qualifications

  • Previous experience in managing synthetic chemistry outsourcing activities and project management is preferred

  • Possess expert knowledge and extensive experience in synthetic organic chemistry including demonstrated examples of solving complex synthetic challenges

  • Have excellent organizational, time-management and oral/written communication skills

  • Be able to leverage strong interpersonal skills to foster relationships between Genentech and CROs

  • Be self-motivated and excited to make an impact on small molecule drug discovery 

  • Have attention to detail, accuracy, and timelines

  • Available for occasional travel both domestic and international

#LI-ES1

9/17/20 Scientific Researcher/Senior Scientific Researcher, DMPK Individual contributor South San Francisco, California

The responsibilities of a DMPK-BA Scientific Researcher/Senior Scientific Researcher are to develop new bioanalytical methods to support new modality drug discovery; adapt new technology platforms and novel tools for DMPK challenges; maintain current knowledge of latest bioanalytical methods and technologies and participate and present in cross-functional project teams. 
The DMPK department is dedicated to enabling the discovery, development and commercialization of safe and effective medicines by elucidating the mechanisms of absorption, distribution, metabolism, and excretion of small molecule drug candidates. We accomplish our goals through the application of state-of-the-art technologies for bioanalysis, drug metabolism, drug transport and pharmacokinetics. The DMPK department works in close partnership with disciplines such as medicinal chemistry, in vivo pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology and regulatory to optimize lead compounds, select clinical candidates, conduct preclinical studies, support clinical development and contribute to IND and NDA filings. 
 Qualifications:
  • Master degree in analytical chemistry, pharmaceutical science or BS with 2-5 years relevant industry experience that focused on mass spectrometry analysis of small molecules, peptides, nucleic acids, proteins or glycans. 
  • Hands-on experience with biological sample preparation and LC-MS analysis is preferred; 
  • experience with AB Sciex triple quadruple or Thermo Orbitrap is a plus. 
  • The candidate needs to possess a demonstrated ability to work independently in a fast-paced environment, as well as in a team setting. 
  • The candidate should have excellent organizational and communication skills. 
  • The candidate should have basic understanding of pharmacokinetics and drug metabolism principles.

#LI-ES1 #dmpk #scientificresearcherjob

9/17/20 Associate Scientist/Scientist Digital Pathology Individual contributor South San Francisco, California

We seek a highly motivated Associate Scientist / Scientist within the Oncology Biomarker Development (OBD) Data Science Digital Pathology Group, to drive digital pathology biomarker development and diagnostic development using image analysis and machine learning. In this role, you will collaborate with pathologists, cancer biologists, bioinformaticians, statisticians and AI engineers. Your work will help target our therapies to the patients who are most likely to benefit, and understand tumor biology to build the cancer-curing medicines of tomorrow. 

As an Associate Scientist / Scientist, you are expected to:

  • Design and implement digital pathology strategies for individual biomarker development programs 

  • Collaborate with interdisciplinary teams to select, optimize and apply algorithms to advance our digital pathology-based biomarker development activities

  • Drive scientific and technical innovations collaboratively with other members of the department

  • Support publications in high impact scientific, technical or medical journals

  • Analyze data supporting innovative clinical development programs

  • Represent the digital pathology team through interactions with our key investigators and public presentations

  • Participate and thrive in a fast-paced, interactive and team-oriented culture

Who You Are 

  • Record of scientific leadership as evidenced by first or senior author peer reviewed publications in top tier journals and patents

  • Outstanding presentation and communication skills are a must.

  • The candidate must hold a PhD in the biomedical or engineering field, and / or a MD / DVM or equivalent degrees in pathology. It is imperative that candidates demonstrate both an understanding of cancer biology as well as computational imaging methods.  

  • Minimum of 2 years postdoctoral experience in basic or translational research either in an academic or industry setting

  • Experience with digital pathology is strongly preferred.  Experience with H&E and IHC image analysis, cell phenotyping using multiplexed imaging data, and common digital pathology software such as Visiopharm or HALO would be assets.

  • Familiarity with machine learning and algorithm development with Python and/or MATLAB in the imaging or computer vision field would be valuable.

  • Experience in clinical drug development, bioinformatics, biostatistics or medical devices is beneficial

  • Excellent team working skills and experience working in an interdisciplinary environment.

#digitalpathology

#devsci

#OBDDATA

#LI-gREDKM2

9/17/20 Medical Science Liaison, Rheumatology, Gastroenterology & Immunology- Northern CA-HI Individual contributor Los Angeles, California

Position Overview: 

The Therapeutic Area Medical Science Liaison (TA MSL) is a credible scientific partner responsible for providing clinical and health economic information related to disease states and the appropriate utilization of Genentech medicines (approved and pipeline). This field-based position will engage with healthcare providers, population health decision makers, and patients within their region(s), to further patient outcomes aligned with the overarching objectives of Genentech. In collaboration with their regional partners, TA MSLs are accountable for co-creating the local medical strategy and delivering for their customers. In addition, TA MSLs may be responsible for covering multiple medicines, as well as engaging in broad scientific discussions around patient outcomes and total cost of care, resulting in rich customer insights shared with key stakeholders across the organization.

Key Responsibilities/Accountabilities: 

  • Ensure an end to end customer experience for TA specific customers within the region
  • Demonstrate deep scientific expertise about assigned molecules/products, franchise(s) and overall therapeutic area(s) to exchange relevant information and insights with top tier thought leaders and healthcare decision makers within a region
  • Build, cultivate, and leverage relationships with key external scientific and medical customers and organizations in their region(s) to ensure strong understanding of evolving healthcare trends across the relevant therapeutic area landscape
  • Demonstrate proficiency in topics beyond scientific exchange such as value / cost of care discussions, hospitalizations, risk of progression, drug pricing pressures, reimbursement education, and AE management
  • Engage in continuous independent learning within the therapeutic area they represent and actively attend and participate in upskilling programs related to assigned molecules, products, disease states and relevant business topics
  • Respond to on and off-label questions with integrity, compliance, and adherence to legal, regulatory, and Genentech guidelines, policies & procedures
  • Build and cultivate important working relationships across field partners to ensure an enterprise approach when working with customers.  Be accountable to the regional team to shape and execute on local medical strategies within planned timelines
  • Depending on regional needs and priorities, may be asked to serve in a Medical Affairs Executive Director (MED) role with specific customers
  • Identify and bring insights back in house to Genentech stakeholders through efficient and effective use of CRM system
  • Assist with Phase I - IV sponsored and supported clinical trials, health economic outcomes research, other TA specific medical collaborations; provide clinical expertise and feedback regarding operational management of clinical trials to ensure optimal site selection and performance
  • Share clinical and value-based expertise in the development and management of clinical and scientific communications for customers to include publications, conference data, and educational materials, as well as for internal Genentech communications and materials to be used in training and development activities
  • Ensure assigned goals and objectives are met and that assigned projects and other work are completed on time, with high quality, and within budget

Qualification: 

  • Advanced Clinical/Science Degree required (e.g., MD, PharmD, PhD, MSN, NP, PA etc.).  BSN with extensive clinical experience may be considered.

Knowledge:

  • GCP (Good Clinical Practice) and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) proficient
  • In-depth knowledge of Phase IV/post-marketing drug development is preferred
  • Relevant therapeutic area knowledge, dependent on customer base
  • Comprehensive understanding of product and safety profiles
  • Understanding of managed care, health economics, healthcare reimbursement, managed care customers and the distribution channels relevant to pharmaceutical/biotechnology organizations
  • Familiarity with the current legal and regulatory landscape pertinent to the pharmaceutical/biotechnology industry

Required Experience:

  • Minimum of 5 years related work experience (clinical, managed care, or industry experience)
  • Prior experience as a field medical science liaison is preferred
  • 2 or more years’ clinical or health economic research experience (either in industry or in another, related setting) is preferred
  • 2 years' experience in therapy area is preferred

Skills:

  • Ability to learn other disease or product areas as business needs and product life cycles change
  • Outstanding organizational and time management skills; proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion
  • Proven track record of meeting or exceeding objectives and goals
  • Strong attention-to-detail
  • Learning mindset, open to training and becoming an expert across customer types or multiple therapeutic areas
  • Outstanding business acumen; knows the industry, Genentech's business model and value proposition, key competitors and other marketplace factors/dynamics
  • Excellent communication and collaboration skills; exhibits professional maturity, confidence, and competence. Strong conflict resolution skills; proven ability to effectively and quickly achieve conflict resolution with affected parties and work in a cross functional environment
  • Knows how to summarize and communicate complex information and business objectives in a concise and effective way for important presentations and decisions
  • Embraces change, embodies a continuous improvement mindset, and exemplifies agile principles in day-to-day activities
  • In addition to passing Genentech's background screening, the employee must submit to and pass additional background screening as required by some institutions and health facility sales accounts (additional screening requests may include but are not limited to background checks, immunization, TB, HIV, hepatitis, and drug screening)
  • Business travel, by air or car, is required for regular internal and external business meetings (up to 70% of time)
  • This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business

#LI-COMMCG2

9/17/20 Senior Manager, Change and Internal Communications, Genentech Early Clinical Development Individual contributor South San Francisco, California

Local candidates only. No Relocation Available for this position.

As the Sr. Manager of Internal Communications, you will develop and implement internal communications strategies for the Genentech Early Clinical Development (ECD) organization to drive business performance, organizational culture and employee engagement.   You must have exceptional communication skills, be a critical and systems thinker, and have the capability to foster relationships at all levels. This role engages across and beyond the Early Clinical Development organization, including with senior leadership, to support the development of relevant, high impact communication strategy and tactics. 

This role offers a unique opportunity for the ideal candidate to drive strategy and senior leader communications, while working cross functionally to implement best-in-class organizational communications and change management practices.

This position reports to the Head of Knowledge Development, Management, and Communications for Genentech Early Clinical Development.  

Major Responsibilities:

As a member of the Knowledge Development, Management, and Communication team within Early Clinical Development’s Business Operation group, this role will work broadly across all Early Clinical Development functions as well as other partners in gRED and beyond.  This position is responsible to:

  • Manage the execution of a communication, change, and engagement strategy that anticipates the changing nature of work (e.g., agile teams, news ways of working, digital transformation), evolving employee needs/wants (customization of content, varied delivery), and an increasingly competitive landscape for recruitment and retention.

  • Consult and support senior leaders and functions/teams within Early Clinical Development regarding leadership communications, channel usage, and change and engagement strategy and tactics. Partner closely with key stakeholders to develop internal messaging and communication plans that help drive results and advance strategic priorities and initiatives.  

  • Develop a leadership narrative with the goal of shaping and influencing employee sentiment, building trust and confidence in Early Clinical Development’s leadership. Bring the leadership narrative to life through communications and engaging experiences including meetings, in-person and virtual events, and through rich digital/video storytelling to drive enterprise-wide understanding of key leadership priorities.

  • Provide well-written, researched, validated, clear, consistent business communications on a range of topics that span organizational announcements, leadership communication, meeting presentations, multimedia, scripts, key messages and talking points

  • Envision and oversee the development of experiences and events that positively engage Early Clinical Development employees. Ensuring continued innovation, inclusivity, creativity and strategic agility so that our programs remain fresh and compelling, and accessible, to all employees. Scope includes but is not limited to special events, patient speakers, celebrations, all-employee town halls, as well as envisioning and establishing new experiences and traditions for our employees.

  • Manage internal communications editorial calendar.

  • Set and assess success of communications and programs through metrics.

  • Develop and execute communications in support of change management.

  • Cultivate a mindset of experimentation, agility and smart risk taking across to drive innovation and creativity.

Qualifications:

  • BS/BA required

Experience:

  • 8-10 years of experience in a communications role in a large, matrixed global organization

  • Extensive experience developing communications strategies and plans

  • Strong understanding of executive communications, employee engagement, channels and event management

  • Experience in digital transformation and change management strategies, activities, communications, and execution is preferred.

  • Biotech or pharma experience in the research/early discovery and development area is highly desirable

  • Science background preferred

  • Experience directly engaging with senior management with minimal oversight

To be successful the Senior Manager of Internal Communications must:

  • Have a clear impact/results orientation and ability to set compelling goals, ensure clear accountabilities and grain alignment to deliver on commitments

  • Translate scientific research into communications suitable for a broad audience

  • Demonstrate change management communications expertise

  • Demonstrate strong executive presence and cultivate trusted relationships with senior leaders

  • Have outstanding communication and presentation skills, both written and verbal. Highly effective at distilling complex and sometimes voluminous content into clear, concise and engaging communications

  • Demonstrate strategic agility. Has knowledge of the life sciences industry and is able to bring this knowledge to bear when advising stakeholders and partners on communication strategies, plans, objectives, tactics, implications and impact

  • Demonstrate expertise developing employee engagement communications plans and campaigns, including knowing how to use creative design effectively to enhance engagement in corporate programs and innovative communications technology platforms to deliver compelling communications content

  • Demonstrate strong consulting skills with the ability to quickly assimilate business needs and circumstances and effectively advise others

  • Effectively advise internal stakeholders and partners on the most strategic, high-level or complex matters

  • Showcase outstanding time management and organizational skills. Consistently executes multiple, and sometimes competing, activities and complex projects to a high quality conclusion, on-time, and within-budget

  • Have strong customer-orientation and a proven track record of collaborative work relationships

  • Be highly skilled at influencing without authority 

#InternalCommunications #Biotech #ScientificCommunications #SFBayArea

9/16/20 Marketing Manager - MS/NMO Individual contributor South San Francisco, California

Marketing Manager – MS/NMO

Position Summary

As member of the MS/NMO marketing team, the marketing manager will identify customers insights and deliver marketing tactics aligned to customer needs, as well as the overall marketing strategy.  The individual will be able to flex across the business, and deliver tactics that reach patients, providers and/or payers dependent upon the business priority.  The ideal candidate will understand core marketing principles, demonstrate strong business acumen as well as have a passion for putting patients first.

This individual also lives the CMG Operating Principles (I put the patient first always; I am tenacious in meeting customer needs; I act on behalf of the whole company, not just my own team; I am accountable; I use time and resources to create the most impact; I am inclusive; I have a bias for action; I build a culture of trust; My career will thrive as I grow my capabilities and increase my impact; I act with integrity). 

Key Responsibilities

  • Supports the development and execution of product value proposition, brand positioning and messaging, and the end-to-end customer experience.
  • Responsible for development and optimization of marketing materials and channel mix to reach target customers.
  • Demonstrates an ability to understand marketing strategy and develop materials or initiatives to deliver against a strategy
  • Uses and commissions appropriate marketing research needed to drive the product in the market and to inform the optimal end-to-end customer experience
  • Identifies and works regularly with network partners to deliver product marketing activities
  • Accountable for high quality, compliant execution across all marketing platforms and customer types (e.g. patients, providers, organized customers)
  • Prioritizes and creates personal messages and resources for field-based channels in coordination with non-personal messages and resources
  • Monitors marketing activity usage, performance, and customer satisfaction to optimize campaigns and drive customer and business outcomes
  • Partners with the Promotional Review Committee (PRC), including Legal and Regulatory, to ensure development, approval, and pull-through of compliant and effective promotional tactics
  • Leads and/or participates in flexibly deployed work teams across the CMG network, contributing novel ideas or approaches based on their areas of expertise
  • Works autonomously to make decisions and act, in close alignment with the full product value proposition, customer positioning, and Squad priorities

Demonstrates Foundational Capability within the following Key Areas

• Customer, Product and Market Insights:  Ability to understand, integrate and synthesize insights across customers, competitors, therapeutic or business areas and markets to inform customer-centric business decisions

• Financial Acumen:  Ability to use financial information and capabilities to inform investment decisions, manage external partners and budgets, and drive sound business decisions

Value Creation: Ability to develop and communicate the unique value and promise that Genentech’s products and solutions provide to its customers 

• Strong agency management skills 

• Business Strategy: Ability to make choices and identify key metrics to deliver measurable customer and financial objectives that drive business forward.

• Customer Experience: Ability to create and execute customer-centric programs and solutions to positively and meaningfully engage customers across the care continuum

• Market Execution: Ability to create, implement and iterate impactful tactics with clear and measurable outcomes to the business and the customer

• Account Marketing and Partnerships: Ability to identify, develop and maximize effective working relationships with customers and partners to gain alignment on customer needs and optimize business and customer outcomes

Skills and Competencies

  • Strong working knowledge of all aspects of brand marketing to include positioning, branding, campaign development and channel mix
  • Knowledge of the healthcare ecosystem including health economics, policy and the regulatory environment
  • Knowledge of each critical customer type e.g. patients, providers, organized customers as well as their experiences and their needs end-to-end
  • Ability to think with an enterprise mindset
  • Ability to influence and inspire individuals and teams across the CMG network
  • Experience in a product/therapeutic area, access or interactive Marketing
  • Ability to flex and thrive in an ambiguous environment undergoing transformational change
  • Strong customer orientation and focus
  • Financial acumen and analytical skills to effectively interpret and utilize quantitative and qualitative data to shape strategies and tactics
  • Ability to translate strategic direction into action plan for self, and make progress in the face of ambiguity
  • Good judgment in recognizing the distinction between "good enough" and perfection
  • Embraces change, embodies a continuous improvement mindset, and exemplifies agile principles in day-to-day activities

Recommended candidate profile

  • Bachelors degree in Marketing / Business preferred
  • MBA or other related graduate level degree preferred
  • 7-10 years experience with the majority working in a product marketing function or relevant role
  • Experience in the managed care, pharmaceutical or biotech industry/pharmaceutical or biotech field sales
  • Marketing experience in other relevant industries
  • Experience in creating marketing strategies, plans and tactics that have strengthened market positioning and driven high-value customer and business outcomes

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