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Responsibilities: 

*Manages and supports applications and systems and ensures integrity, operational stability, and validated state during their lifetime

*Ensure that operational work, project related activities and on-call services are performed according to defined KPIs

*Contribute to the core business and informatics processes and solutions by applying specific knowledge of systems and tools, as well as problem solving skills, to support these processes and solutions

*Installs new systems and new releases into maintenance and productive environment, following change management procedures

*Coordinates and supports security patching and upgrades with business and all informatics functions

*Ensures appropriate quality system documentation including technical system documentation, installation scripts, OQ/PQs (Operational Qualification/Performance Qualifications), test plans and scripts

*Follows incident and change control procedures and enhancement governance procedures

*Resolve or escalate problems for resolution when appropriate 

*Maintain and develop process and technical knowledge

*Collaborate with end users to identify needs and opportunities for improved data management and delivery

*Provides Subject Matter Expertise (SME) input into detailed design solution

*Supports collection of user and functional requirements, and translates them into design specifications.

*Supports the test design; conducts and supports functional testing; supports user acceptance testing.

*Supports roll-out activities and data migration

*Delivers quality solutions within committed timeframes



Requirements:

*5 to 7 years of experience, as well as in a regulated environment with Computer System (laboratory or manufacturing experience as 2nd level support)

*Experience with business processes in the manufacturing or laboratory environment

*Experience in a project environment and in Informatics Service Support and Service Delivery 

*Experience in system application installation and maintenance of operating systems, hardware and peripheral devices e.g. bar code scanner, printer etc.

*Ability to learn new technical concepts and systems

*Highly adaptable to change

*Tools: Windows 2003/2008/2012; VMware; Citrix; Windows 7; Windows 10

 

Preferred:

*CSV experience (preferred 2-3 years of experience) 

*MES (Manufacturing Execution Systems) experience

*Track & trace experience

*Strong technical skills in different applications and platforms 

*Service oriented attitude, being able to communicate with our customers, also in emergency situations

*Excellent communication skills

*Team player 

Job Responsibilities:

• Strengthen the overall Engineering community by building bridges and collaborating with Principal and Senior Engineers in other Infrastructure Solution Areas

• Interact with Senior internal and external personnel on significant technical matters as it relates to priority objectives

• Contribute to determining success criteria for the evaluation of promising solutions/technologies via Proofs of Concept (PoCs) and feasibility studies across two or more areas within Collaboration and Facilities IT space, as they related to meeting Roche’s business needs

• Architect, design, build, test, and deploy (first-time) integrated, resilient and reliable solutions in multiple solution areas across the entire Collaboration and Facilities IT Solution space

• Manage small-to-medium sized technical teams for specific objectives in medium-to-large initiatives (projects, lifecycle work, PoCs, etc.) and to provide the expert guidance required to drive technical developments in these initiatives

• Advise, influence, collaborate with, and synthesize feedback from various IT partners

• Ensure solutions in collaboration and Facilities IT space align and adhere to the organization’s Technical Architecture Framework (TAF) policies, standards and directions

• Map the technology roadmaps into portfolio projects/activities and to estimate resources, dependencies, risks, and timelines required to deliver these projects/activities successfully

• Contribute and/or write position papers, white papers, best practices and use cases for their infrastructure solution space

• Stay abreast of operational challenges and opportunities related to Collaboration and Facilities IT space

• Partner effectively with operational support teams to provide efficient internal/external escalations and problem/incident resolutions

• Ensure solutions implemented fit within the Quality/Regulatory standards, as applicable

Job Requirements/Qualifications:

• Bachelors Degree and at least 4 years experience working in one or more multinational work environments.

• Pharma/biotech/healthcare industry experience is a plus as a senior level Infrastructure Engineer in the role of Facilities IT/ Collaboration Engineer.

• Deep knowledge of the following technologies:

  • Cisco Telepresence and Video Conference solutions.

  • Unified Messaging, preferably based on gMail.

  • IT Audio Visual design.

  • Digital Signage solutions.

  • Whiteboard solutions

  • Systems Integration solutions

  • Webcast

  • Audio Visual equipment for auditoriums.

  • Video and Audio conferencing

  • Working space/Shared spaces design that enhance collaboration.

• Technical experience in deployment and support of:

  • Auditorium audio visual solutions;

  • Digital signage solutions for multinational environments;

  • Systems Integrated solutions such as whiteboards, collaboration technologies, display, video walls and content sharing;

  • Centralized video clustering solutions where the rooms are distributed in multiple countries in a region;

  • Telepresence solutions where the rooms are distributed in multiple countries in a region.

• Strong interpersonal skills

• Well demonstrated customer & delivery focus

• Strong customer engagement and presentation skills with the ability to communicate across all levels (senior and/or large audiences)

• Ability to work effectively with team members and virtual teams from different locations and different cultural background

• Ability to function strategically and independently with minimal supervision

• Excellent problem solving and decision-making skills

• Strong oral and written communication skills in English (mandatory) with German, Spanish or Chinese (Mandarin) as a significant plus

• Proven project and time management skills

• Moderate to extensive travel required and ability to work across multiple time zones, including some on-call and extended hours work, as required

• CCNA Collaboration/CCNP Collaboration

The Senior Business Systems Analyst for ECDi Systems Operations is responsible for working with end users to discover and understand business needs and translate them into requirements as well as drafting and maintaining all required SDLC and validation documents as needed.  This position will work in close collaboration with ECDi, Program and Study Management, IT and other business partners to participate in strategic discussion and any discussions related to technology upon request.  This candidate will be proactive and detail-oriented with strong leadership skills, excellent problem solving and written/verbal communication skills.  This individual is expected to deliver outstanding customer service, provide technical and application support knowledge and ensure effective communication to all levels of stakeholders including business sponsorship.      

Primary Responsibilities and Accountabilities:

• Facilitates requirements definition sessions with stakeholders to capture business requirements effectively
• Understand the functional business process across the organization
• Follows defined validation processes and produces validated documents for all initiatives
• Evaluates information gathered from multiple sources and works with stakeholders to reconcile conflicting information, identify/evaluate potential risks and translates into written documentation
• Drafts all required SDLC, validation documents and technical documents as needed
• Document Functional Specifications and Test Plans for system enhancements
• Collaborate with business stakeholders in writing User Acceptance Test cases as needed
• Review vendor documentation and training materials and assist with end user training as necessary
• Collaborate and partner with business users to ensure system operates effectively and meets the requirements of the business as well as fits within the ecosystem of the organization
• Collaborate with system vendor(s) to ensure system development meets business and technical requirements
• Support Project Lead(s) on other needed activities for project success
• Oversees and manages vendor relationship with system vendors as needed

Experience, Skills, Knowledge

• Experienced with the processes and principles of program and project management and business systems analysis
• Up-to-date knowledge of clinical operations processes and Information Systems
• Broad knowledge of applied GxP experience in pharmaceutical or Biotech industry with clinical drug development experience
• Detailed working knowledge of Software Development Life Cycle (SDLC)
• Proven track record of success analyzing, defining and overseeing requirements for applications, products or system integrations
• Demonstrated ability to function independently with a proactive, self-starter attitude
• Analytical problem-solving skills to enable ability to define problem statement clearly and accurately and apply structured and disciplined methodology to identify root-causes
• Highly effective verbal & written communication skills
• Highly effective team player and interpersonal skills (globally, internal and externally)
• Experience working in a regulated technical environment and/or previous experience with clinical software preferred
• Strong customer focus

Education:

• Bachelors degree or equivalent years of experience
• 8+ years experience functioning as Business Systems Analyst or similar role

#LI-GREDKM2

The Cell Culture group is seeking a dynamic leader to provide technical and strategic leadership to a group responsible for developing, implementing, validating and tech transferring recombinant protein production processes.  In addition, the role provides strategic guidance for Health Authority submission content. 

Responsibilities

• Direct cell culture (primarily CHO) process development, validation and tech transfers.
• Provide strategic guidance for process validation studies and Health Authority submission content.
• Develop solutions to complex biological and engineering problems requiring the regular use of ingenuity and innovation.
• Leverage strong management skills to lead, mentor, motivate, and develop staff.
• Motivate and support the career development and technical expertise of staff. Regularly meet with, set clear goals and expectations, and provide timely feedback to all staff in the group. Hire, develop and retain the best people.
• Deliver effective technical presentations to senior management within Pharma Technical Development (PTD) and outside groups within the company.
• Act as a sponsor for early and late stage projects and Technical Development team leaders. 
• Develop strategies for Health Authority submission content; author/review submissions for Health Authorities; interact and represent Cell Culture department during Health Authority meetings and/or inspections; perform group and management reviews of Health Authority submissions.
• Provide strategic leadership for the group and the entire Cell Culture organization.
• Participate in defining Cell Culture’s goals, timelines and budgets.
• Represent the group within the Cell Culture department and productively interact with customer groups outside of the department.  Lead cross functional teams within the PTD organization and serve as a department representative in technical review forums.

Qualifications

We are seeking applicants with strong technical and leadership capabilities. The level of the position will depend on the qualifications of the selected candidate.

• PhD in biochemical engineering, microbiology, molecular biology, biochemistry, or related field.
• 8+ years experience with cell culture process development, validation, tech transfer and Health Authority interactions. 
• Significant experience with process validation and licensure of biologics.
• Good understanding of cell physiology, metabolism, and cell biology.
• Significant managerial experience directing PhD level staff. Demonstrated ability and experience in managing large groups of technical and managerial staff.
• Demonstrated excellence in leading and managing projects.
• Demonstrated ability to lead innovation and change, and drive for results.
• Demonstrated excellent leadership skills, strong teamwork and collaboration skills and ability to provide insight and guidance to staff.
• Experience in interactions with Health Authorities, including authoring and reviewing of regulatory submissions and interacting with Health Authorities during meetings and/or inspections.
• Solid understanding of phase appropriate GMP requirements and U.S. and European regulatory requirements.
• Strong communication skills. 

#LI-PTD-JM

Please note this is a Contract position 6 months or longer, could lead to a full time Genentech opportunity. There are multiple shifts available (day or swing) and multiple positions.

Main Purpose of the Position:

Under the direction of Inspection Supervisor or other qualified Operations Specialist, perform a wide variety of tasks and operations that are required to formulate, fill, inspect and package sterile pharmaceutical products in a state-of-the-art, automated production and packaging facility.  Troubleshoot, maintain, and assemble all production equipment as required.  Assist the Operations Specialist on major equipment overhauls, repairs, and installations as necessary.  All operations will be carried out in compliance with cGMPs, Standard Operating Procedures (SOPs), product recipes, and Genentech standards.

In addition to performing the responsibilities/tasks below, the successful candidate will need to demonstrate the following traits:

• Passion and drive to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customers.
• Embraces Class A principles and behaviors.
• Continuously in search of ways to maintain the highest levels of productivity.
• Actively participates in a teamwork environment that maintains a high performance culture.
  
   

Responsibilities:

• Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
• Perform safety and housekeeping audits as required.
• Assist in set up, change over, and test run equipment for various-sized vials and packages as required.
• Supporting the Operations Specialist Maintenance, and/or outside services in the repair, maintenance, and calibration of GNE Systems as required.
• Perform training of other Technicians.
• Assist in the development of plant SOP’s and training materials.
• Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
• Operate all formulation, sterile filling, inspection, and final vial packaging equipment in the plant.
• Perform preparation of sterile components.
• Assist in the cleaning, set-up, sterilization, and disassembly on a variety of processing equipment.
• Perform bulk thaw, dilution, and formulation operations.
• Performing manual inspection of empty vials and filled product with a focus on quality and efficiency.
• Conduct environmental monitoring activities in the manufacturing areas as required.
• Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
• At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs, process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency.
• Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
• Perform cleaning and housekeeping duties as required.

Requirements: 

Proficiency in the English language – reading, writing, and communication.  Must be able to work all shifts (1st, 2nd, or 3rd), required overtime as needed, able to lift 45 pounds, and stand for extended period of time.  Must be able to successfully pass all job-related tests and certifications required for working in a cGMP, quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the job.  Must re-qualify every year on all job-related tests and certifications as job or qualifications require.  All candidates must pass a vision acuity and color discrimination test.

Education:

• High school diploma or equivalent AND
• Graduate of a two-year Associates Degree program in Electrical/Mechanical Technology (or equivalent) is a plus.

Experience:

1 to 2 years (within the last 7 years) experience in the operation of complex mechanical equipment used in the washing, filling, conveying, sealing, inspection and packaging of products/containers is highly desirable.  Target industries include pharmaceutical, biotechnology, biomedical, electronic, and chemical, food, cosmetics, and/or other medical industries.

Computers:

Must be computer literate, including ability to interface with computer systems and PLC-based logic.  Must be comfortable working with Microsoft suite (Word, Excel, PowerPoint), navigating through web pages and e-mail.  Must possess basic typing skills.

The Human Factors Engineer will provide human factors engineering expertise to project teams developing combination product drug delivery devices at Genentech, taking into consideration all aspects of the user, the intended use, the use environment, and the drug therapy being delivered. The Human Factors Engineer will collaborate with multi-functional teams including device engineering, regulatory, clinical, quality, marketing, and program management to inform and guide development of innovative products and ensure that those products are safe and easy to use. As part of product development, they will conduct human factors engineering activities within device development programs including ethnographic research, requirements definition research, use-related risk analysis, formative usability assessments, and final summative design validation studies. They will also develop instructions for use and training materials for clinical trial and commercial purposes.

Qualifications

• Bachelors degree in human factors engineering, mechanical engineering, bioengineering, or related discipline
• 3+ years of experience in applying HFE to medical device or combination product development
• Experience writing formative and summative usability study protocols and reports and human factors summary reports consistent with health authority expections
• Experience working cross-functionally on risk management activities
• Experience designing instructions for use (IFU) documents and training materials for medical devices/combination products and conducting usability testing of them
• Experience working with human factors external consultancies, or as part of an external consultancy team that supported the design and development of new medical devices
• Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics
• Proven ability to clearly communicate how study results can be implemented into design
• Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidances for medical devices and combinations products
• Ability to communicate effectively in writing, verbally, and as a presenter
• Demonstrated time management, decision making, presentation, and organization skills
• Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team
• High level of initiative and ability

#LI-PTD-JM

As (Associate) GROUP DIRECTOR within our Personalized Healthcare function you will be responsible for the Real World Data (RWD) strategies in Ophthalmology, and lead a team of Data Scientists using meaningful data to generate impactful evidence and insights on our molecules/medicines and patients that support R&D, advance scientific and medical knowledge, and enable personalized patient care and access.

The data will be varied in type -- patient-level clinical data, supplemented with deep patient data like omics (e.g. genomics, proteomic), imaging, digital health, etc. Source data will be diverse -- real-world data, including patient registries, electronic medical records, claims, biobanks, and clinical trials. The data science solutions will address molecule and disease area questions that will inform the research and development of our molecules, and support healthcare decisions by patients, physicians, health authorities, payers, and policy-makers. As a leader of the organization, you will also lead or contribute significantly to functional, cross-functional, enterprise-wide or external initiatives that shape our business and healthcare environments. This will require a deep understanding of molecule and disease area strategies, our business, healthcare environments, as well as scientific and technical data science expertise. You will need excellent strategic, leadership, collaboration and communication skills, as well as an entrepreneurial mindset, to work with and through others, to transform the way we use data and analytics to develop and deliver medicines for our patients and to achieve the business objectives.

(Associate) Group Director

Strategic and implementation responsibility for RWD Ophthalmology. Responsible for leading a group of RWD Scientists.

RESPONSIBILITIES

• DEVELOP & DRIVE DATA STRATEGIES: Develop and drive overarching data science strategies, in collaboration with internal partners, to support research and development of our molecules and enable personalized patient care and access.
• DELIVER PORTFOLIO AND BUSINESS: Resource molecule and disease area teams and initiatives effectively with internal and outsourced capabilities to deliver high quality, rigorous and fit-for-purpose data science solutions according to company priorities and opportunities to impact business.
• SHAPE INTERNAL & EXTERNAL ENVIRONMENT: Lead or contribute significantly to functional, cross-functional, enterprise-wide or external data science communities, networks, collaborations, initiatives or goals on knowledge-sharing, methodologies, innovations, technology, IT infrastructure, policy-shaping, etc. to enable broader and more effective use of data and analytics to support business. 
• BUILD INTERNAL CAPABILITIES: Hire staff with appropriate skills, experience and potential, and cultivate an environment that attracts and retains talents. Ensure adequate training of our staff, provide business context and connection of our work with company priorities and values, inspire our staff to set high-standard goals and objectives and support them to achieve them.
• ACQUIRE EXTERNAL CAPABILITIES: Collaborate with internal partners in due-diligence to assess and acquire/ collaborate with external capabilities in data, analytics, technology, etc. of strategic business fit to the business.
• INNOVATE OUR FUNCTION: Define functional objectives and strategy, identify opportunities, gaps and priorities, and contribute to best practice standards. Stay abreast of emergent applications, methodologies, technologies, and external guidelines, and implement change to positively evolve the function’s capabilities and impacts.
• FOSTER OUR CULTURE: Develop strong internal partnerships to promote effective collaborations. Lead by example in promoting a collaborative and entrepreneurial culture and a global mindset. Be an agent for change and engage support for innovative ideas and solutions.

MINIMUM QUALIFICATIONS

• MSc, PhD, MD or similar qualification in a quantitative data science discipline (e.g., statistics/ biostatistics, epidemiology, bioinformatics, health economics, computational biology, computer science, mathematics, outcomes research, public health, biology, medicine, psychology)
• 4+ years of work experience in drug development (e.g. pharmaceutical industry, CRO).
• Demonstrated track record of leading and execution of complex data science research projects, including publications, and leading teams (e.g. in cross-functional projects or in matrix structures)
• Demonstrated track record of patient-level data analyses (e.g., real world data, surveys, clinical trials, registries, claims, omics or imaging data)

• Excellent communication skills. Proven ability to translate and communicate complex ideas, concepts, and data science solutions to diverse audiences
• Proven ability to think strategically and successfully implement new strategies and ideas

• Excellent collaboration and leadership skills. Ability to motivate and inspire teams and manage change
• Proficiency in English, both written and verbal

PREFERRED/ADDITIONAL QUALIFICATIONS

• PhD degree in a quantitative or health sciences discipline as listed in Minimum Qualifications
• Subject matter expert of R&D, regulatory and/or health care systems use of real world evidence for decision-making
• Experience in Ophthalmology, applying real-world data to support development programs and in-market products

#LI-PDHB1

We have an opening for a talented Scientific Researcher/Senior Scientific Researcher to join our Biochemical and Cellular Pharmacology Department within Genentech’s Research and Early Development (gRED) organization.

The successful candidate will be responsible for supporting biochemical and cellular characterization of protein therapeutics for various therapeutic areas, including oncology, cancer immunology, inflammation and neuroscience. More specifically, the individual will develop, validate and execute biochemical and cell-based assays to characterize and screen biologic therapeutics in vitro and ex vivo, to support lead-finding and optimization efforts, as well as mechanistic characterization of candidates.  

Responsibilities include developing and implementing pharmacodynamic assays and quantitating biomarkers. In addition, the candidate will function as part of a multi-disciplinary project team that will coordinate with Antibody Engineering, Protein Chemistry, Therapeutic Area and Translational Research groups to advance lead molecules of the projects. The candidate will have the opportunity to present their work to project teams and senior management, and is expected to contribute to publications and present at scientific conferences.

Who You Are

• B.S. degree (M.S. degree preferred) in Immunology, Biochemistry, Cell Biology, or a related field with 3 to 6+ years of relevant immunology/immuno-oncology and/or cell biology experience in academia, biotechnology and/or pharmaceutical industry
• Practical experience in the design, development, validation and execution of biochemical and cell-based assays to characterize protein therapeutics
• Experience with flow cytometry, cell-based functional assays, ELISA assays, and culture of mammalian cell lines and primary cells from various species
• Ability to work independently to design, execute, and interpret experiments, and also collaborate with project teams
• Record of publications that demonstrates expertise
• Excellent teamwork, communication, time management, and organizational skills

Additional desirable skills

• A strong foundation in immunology or cell biology and hands-on expertise in immune cell and/or other primary cell based assays to interrogate the function and bioactivity of antibody and protein therapeutics
• Experience with primary immune other primary cell isolation, culture and differentiation
• Experience with microscopy and/or high content image analysis
• Experience with Luminex assays
• Familiarity with automated or semi-automated instrumentation
• Familiarity with the multi-disciplinary activities of antibody lead profiling

#LI-GREDRM1

We have an exciting opportunity for a talented chemist to join our Small-Molecule Drug Discovery Chemistry Department at Genentech in South San Francisco, CA. The successful candidate will be responsible for designing and synthesizing analogs for molecular targets during the lead identification and optimization stage as part of a drug discovery team.

Applicants should have 0-10 years of post PhD, or equivalent experience, in chemical research. Solid knowledge in modern synthetic organic chemistry is required. Preferred applicants will demonstrate extensive experience and record of accomplishment in one or more of the following areas: medicinal chemistry, methodology/catalysis, total synthesis, chemical biology and physical organic chemistry. Applicants should convey strong verbal and written communication skills and an ability to work collaboratively in teams.

The Technical Development Leader (TDL) leads technical development team(s) in developing and implementing CMC strategies and activities associated with large or small molecule clinical candidates, from pre-entry into humans until launch.  He/she is the primary advocate for development programs on CMC strategies, activities and issues and is accountable for ensuring that Technical Development Teams are successful in achieving their goals.  He/she represents CMC functions with stakeholders, on Project Teams and when interacting with external partners.  The TDL also ensures adequate information flow between team members, to functional management, and to governance committees to ensure transparency, informed decision making, and optimal alignment of all technical deliverables with the Project Team strategy and Clinical Development plan.  He/she is also accountable for all project planning, scheduling, resourcing and reporting for the team.

MAJOR RESPONSIBILITIES

• Leads technical development teams in developing and implementing CMC strategies and activities associated with large and small molecule programs from pre-EIH, during preparation of major regulatory filings and approval in major countries.
• Represents the technical development functions on the Project Team; collaborates closely with other Project Team members to define and deliver the project strategy, objectives and plans; ensures that the TDT strategy is aligned with the Project Team objectives and corporate goals.
• Interacts closely with the small or large molecule technical functions and key stakeholders within the Research, Development and Technical Operations organizations globally.
• Provides regular updates to the Project Team and the relevant governance committees; communicates the CMC strategy and activities to external partners as needed.
• Ensures the scientific integrity of the technical development process, CMC strategy, and TDT deliverables
• Ensures the TDT is successful in making progress toward its goals and adheres to timelines, milestones, and resource forecasts as previously defined in Technical Development Agreements and in agreement with license partners (if any).
• Supervises technical development team members in a matrix environment.
• Establishes effective decision-making and risk management processes.
• Monitors, tracks and reports progress against team goals and approved plans.
• Leads TDT meetings and manages the team
• Anticipates and identifies issues, develops contingency and risk mitigation plans, and communicates the potential impact to the relevant governance committees.
• Partners with functional area management and seeks input from functional area forums and committees to ensure that technical expertise is provided as necessary.
• Contributes to the development of department business initiatives and facilitates their implementation.

QUALIFICATIONS

• B.S./M.S/Ph.D. degree in chemistry, pharmaceutics, chemical engineering or related field
• 12 or more years experience in the pharmaceutical industry with prior experience as a CMC team leader, combined with a strong technical knowledge of small and/or large molecule process development and a sound knowledge of the drug development process.
• Proven track record of technical accomplishments.
• Demonstrated ability to build and lead cross-functional teams
• Excellent verbal and written communication skills with success in influencing others in cross-functional areas
• Proven ability to work with cross-functional teams and senior management
• Strong collaborative and relationship-building skills
• Proven ability to work proactively and think strategically
• Experience working with third parties
• Strong decision-making skills and strategic thinking ability

Are you passionate about Technical Product Management and looking for a meaningful role?

With patients’ health and well-being depending on the reliable supply of high quality medicines, effective Product Management of Roche’s portfolio of therapeutic products is crucial. Our group, Technical Product Management and Network Strategy (TPM), is accountable for end-to-end product health to ensure supply to patients. Our organization translates the commercial strategy for a product into a supply chain lifecycle plan. Our leaders sit between Technical Product Development, Technical Operations, and Global Product Strategy, which provides a unique view to the full industrialization and commercialization of our portfolio. Through these partnerships, we develop and execute agile product lifecycle and network strategies. We lead cross-functional teams involving all Technical Operations functions including Supply Chain, Quality, Technical Regulatory, Finance, Drug Substance and Drug Product Manufacturing beginning with raw material acquisition through the various stages of manufacturing to finished product distribution to our customers for the entire product life cycle.

We are hiring a Technical Product Leader (TPL) who will lead cross-functional matrixed Technical Product Teams across Pharma Global Technical Operations (PT) and Roche.

In the role of the TPL, you will be accountable for commercial launch and technical lifecycle management of assigned product(s). You own the end-to-end product strategy and execution throughout the entire product life cycle, from commercial launch to divestment. You will represent PT on the Product Life Cycle and Established Product Teams. As a leader in this organization, you are expected to understand the business drivers for the product, the external risk factors affecting the products success and be able to translate these to support the resiliency of the product supply chain. You will be the PT “Voice of the Product” accountable for driving and articulating the key supply chain decisions for the product.

Your key tasks will include but are not limited to:

• Be the PT “voice” in the Product Lifecycle teams, translating commercial strategy into supply chain lifecycle plans.
• Develop and implement the lifecycle vision, strategic goals, and objectives through effective plans, tactics and resource management
• Develop scenarios to account for changes in commercial forecasting and prepare product supply chains to deliver the upside of the forecast while handling the risk of the potential downside.
• Effectively manage end-to-end risk, ensuring the robustness and resiliency of the supply chain through its lifecycle.
• Lead, manage and support the development of the functional experts assigned to the Technical Product Team (TPT)
• Assure quality supply to patients by developing long term strategies to minimize Compliance risks and building robust and resilient supply chains
• Coordinate and drive resolution of supply and product issues (project planning and escalation according to the agreed criteria).
• Decide on all product related topics within agreed financial, operational and project framework.
• Be fully accountable for the successful global implementation and ongoing management of the PT strategy for the assigned product.
• Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
• Drive teamwork within the Technical Product Teams, PT and Pharma.
• Embrace and employ Lean Production System methodologies including lean leadership and continuous improvement.

Qualifications:

• 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.
• 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; excellent business acumen
• 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

You have strong verbal and written communication skills and the ability to influence at all levels. You are able to travel globally (more than 20%). International/global experience is strongly preferred.

Title:  Clinical Specialist

Level: E3

Territory: Tucson, AZ

Territory covers:  Southern AZ, primarily Tucson but does cover portions of the East Valley and Southern parts of Phoenix metro area

Reports to: Division Manager, Ocrevus

The Ocrevus Clinical Specialist is a field-based position. The candidate must live within 30 miles of the territory boundary. 

Ocrelizumab has been adopted by the multiple sclerosis community based on the groundbreaking randomized phase III data and desirable safety profile relative to the competition. The Ocrelizumab team has the chance to shape not only the large US market, but also the global effort - as the US is ~70% of worldwide sales. In addition, the Ocrelizumab team will chart our course in neuroscience, marking the first launch in this therapeutic area - one that we hope to grow significantly in the future. Ocrelizumab was launched in Q2 of 2017. 

This role reports to the Division Manager, Multiple Sclerosis Franchise. The Clinical Specialist, manages and develops long-term relationships with health care providers and other customers for targeted accounts in the assigned territory. Additionally, the Clinical Specialist will work closely with all other field partners.

Key Duties and Responsibilities: 

• Primary point of account contact
  • Establishes and maintains productive and collaborative working relationships with cross functional groups and peers across franchises 
• Drive demand
  • Responsible for meeting or exceeding assigned sales targets
  • Develops robust territory business plans 
  • Profiles and targets key customers 
  • Develops strong and long-term relationships with customers in all assigned accounts 
• Drive persistence
• Infusion training
  • Provides product educational in-services to customers, including infusion nurses, APPs, pharmacists and physicians
• Product access discussion
• Triage (specific patient) reimbursement needs to ERS
• FPM like Activities
  • Discuss GDP
  • Discuss Provider contract
• Local advocacy Development
  • Build advocacy with Thought Leaders using on-label and PRC-approved materials
• Hospital formulary acceptance
• Presents the assigned GNE brand in a professional, compliant, ethical and effective manner; helping external customers 
• Understand the benefits and use of GNE brands 
• Complies with all laws, regulations and policies that govern the conduct of GNE activities 

Demonstrated strength in the following competencies is critical for success in this role: 

• Technical and Business Expertise (specifically, sales, infusion markets, buy and bill, specialty pharmacy and/or launch) 
• Achieving Results 
• Decision Making 
• Teamwork and Collaboration 
• Communication 

This is a remote position. 



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. 

Qualifications and Experience: 

• Bachelors Degree required, MBA or other related graduate-level degree is preferred 
• 5 or more years’ of field sales experience in the pharmaceutical/biotechnology/or other related industry with an emphasis on commercialization preferred
• Transferable experience (Infusion, Buy and Bill, Specialty Pharmacy, Launch) is preferred 
• Previous/direct managed care experience - either in account management, payer-focused marketing, or other - is preferred
• Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals required 
• Demonstrated experience successfully working and collaborating with cross-functional teams with and without authority required 
• Business travel required 
• Compliance with all laws, regulations, and policies that govern the conduct of GNE activities required

Responsible for leading the Manufacturing Learning Group to deliver learning solutions to meet Manufacturing’s needs. Primary responsibilities include the development, delivery, evaluation, and on-going management of the technical training programs relevant to the Manufacturing department and owning and overseeing all Manufacturing documents through creation and revision.

Job Responsibilities

• Responsible for Manufacturing Training and Document Specialist staff members; scope is the entire manufacturing function- both technicians and off-the floor employees. Leads the team to develop, implement and maintain a comprehensive technical training program for Manufacturing so that new and experienced technicians develop both a breadth and depth of technical understanding for bioprocesses and leads the team to own and oversee the document creation and revision process.
• Establishes and define requirements for on-boarding new technicians with a model to ensure that fundamental knowledge and skills are engrained prior to GMP processing
• Key decision-maker in partnership with Business Support Technical Training department to identify and implement opportunities for improvement of training materials and training skills as it relates to the OCN manufacturing training program.
• Coaches the team to develop and implement processes that are robust and scalable
• Collaborates across the local organization and network to gather expectations, share best practices and coordinate program requirements
• Develops communication approaches to support learning solutions and provide regular status updates on program progress against defined expectations to stakeholders
• Ensures long term sustainability of program
• Serves as a contact and resource for new hires and supervisors/managers regarding MTTP program.
• Provides timely feedback to supervisors in the form of a New Hire Review.
• Establishes measurable goals and levels of competency of each trainee
• Provides trainees with timely and relevant feedback, both positive and constructive
• Defines and implements advanced trainings to increase technical understanding for specific processes / equipment to enable improvement in trouble shooting and decision making
• Conducts training in GMP Manufacturing environment with at least 50% of time allocated directly to on the floor / job training. Flex hours and work schedule to accommodate training needs on all shifts as needed
• Collaborates with leadership to understand training needs and gaps to implement a plan for the shift / department to complete training and ensure staffing is adequate and capable to complete operations right first time and as scheduled
• Provide routine and relevant Regulatory trainings (Safety and Compliance) to improve understanding of SHE and GMP principles and drivers
• Utilize metrics and feedback to monitor the training program efficacy and constantly improve training processes and programs
• Learn and deliver specialty training on an as needed basis
• Lead / participate in training team meetings and training-related projects for Manufacturing
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Promotes a safety culture that support continuous improvement in the EHS management system through active communication and functional area participation in site safety teams ensuring the safe and efficient operation of assigned functional areas and activities. Fosters a positive safety culture in which no one gets hurt.
• Perform Change Owner responsibilities for Manufacturing by managing process area and system change records including: quality actions, technology transfer changes, shutdown activities, inspection responses, and other manufacturing continuous improvements projects.
• Review all manufacturing revision requests and collaborate with technical experts and stakeholders to align on document revision prioritization, necessity, and improvement opportunities.
• Establish and implement business processes to optimize manufacturing document revision.
• Establish and implement documentation guiding principles that align with site training strategy, tech transfer readiness, and adhere to GMP regulatory requirements.
• Lead document revision teams and work streams, as necessary.
• Collaborate with Manufacturing SMEs and technical assessors for document creation and revision.
•  Redline documents using technical knowledge and knowledge of SOP’s
• Act as Trackwise and Condor Subject Matter Experts.
• Act as Manufacturing Subject Matter Expert.
• Train others across the organization on document control processes and procedures, as necessary.
• Collaborate with Technical Training and Training Program Coordinators in the Manufacturing Learning Group to develop training materials and align on training/documentation strategy and guiding principles.
• Utilize and maintain metrics and regularly solicit stakeholder and customer feedback to monitor document efficacy and look for continuous improvement opportunities.
• Improve right-first-time change initiation.
• Provide support to Manufacturing Learning Group and GMP Services as required.

Job Requirements

• AS/BS/BA in Biological Sciences, Physical Sciences, or Engineering or combination of college coursework and related work experience, or Biotech certificate from approved program.
• 6-8 years experience in Bioprocessing at Genentech with some experience in a training related capacity, previous leadership experience preferred
• Ability to build strong relationships and partnerships with business leaders to build trust and influence across multiple levels of the organization
• Strong demonstrated performance to identify business drivers and needs analysis to analyze learning needs
• Proven ability to lead teams and initiatives with direct and indirect authority
• Ability to influence / negotiate through formal and informal networks
• Strong analytical and project management skills
• Strong knowledge of Good Manufacturing Practices, Standard Operating Procedures, and safety requirements within a biochemical-manufacturing environment.
• Strong desire and/or ability to teach and motivate others
• Strong planning and organizational skills and ability to manage multiple priorities at the same time
• Able to quickly and consistently establish rapport and collaborate effectively with clients, team members and partners
• Commitment to achieve results is reached by applying hard work; knows how to get things done through both formal channels and informal networks.
• Ability to establish measurable goals, monitor and assess others performance and provide timely and relevant feedback, both positive and constructive
• Displays exceptional teamwork and collaboration skills
• Strong verbal and written communication skills

This position is not eligible for relocation.

Reporting to the Senior Director of gRED, the Principal Human Resources Manager (PHRM) partners primarily with business leaders, generally at the VP/SVP levels. They will also provide support to Director job families and may occasionally support management (S) levels within Genentech Research and Early Development (gRED) in South San Francisco.  This position will manage complex/matrix relationships, collaborating effectively across the business and HR networks.  The PHRM will be responsible for developing innovative solutions to a variety of unusually complex problems and initiatives. It is expected that they will exercise significant judgment in generating and selecting methods, techniques and evaluation criteria for obtaining results, and working on complex issues where analysis of situations or data require an in-depth evaluation of variable factors, including inter-organizational impact that support Genentech's business objectives.

 

PRIMARY RESPONSIBILITIES:

• Strategic Business Partner to Client and Client Organization: Partner with executive business leaders in support of their overall client group(s) through developing solutions to a variety of unusually complex problems and initiatives exercising significant judgment in developing and selecting methods, techniques and evaluation criteria for obtaining results, and working on complex issues where analysis of situations or data require an in-depth evaluation of variable factors, including inter-organizational impact that support Genentech's business objectives.  The PHRM is the initial point of contact for the majority of strategic HR support requests for their client and has responsibility for evaluating and ensuring effective risk management relative to the Officer organization's employee relations and human resource practices.
• Organization Effectiveness: The PHRM will apply strong technical expertise (such as Organization Design, Workforce Planning, Diagnostics, Change Management), knowledge of the business and environment, and situation specific analysis developing new concepts, techniques, and standards (from concept to execution) in implementing strategy and solutions to address organizational and people-related challenges across the client groups. 
• Partner with and Lead the HR Client Relationship Team: Influence and collaborate with HR colleagues to create, continuously evaluate and ensure strategic, consistent, business-focused Organization-wide Human Resources support aligned with business objectives, consistent with company values and culture and in compliance with laws and regulations.
• Act as initial point of contact to the Heads of the client organizations and other clients as necessary
• Partner/Collaborate with Centers of Expertise (COE:  Compensation and Benefits, Staffing, Learning and Development and Diversity and Inclusion, Employee Relations, Legal) to ensure development of client-based products, tools and solutions
• Proactively disseminate business information to their Client Relationship Team (CRT) - Recommend solutions within their CRT to advance the business
• Identify client business needs and work with the CRT to broker services
• Develop annual integrated goals and plans to support client needs; drawing upon the expertise of their CRT
• Provide meaningful and timely feedback to COE partners
• Demonstrate ownership and accountability of decisions/recommendations made by CRT and/or COE when working with clients
• Understand responsibility is to the larger organization in "Genentech's Best Interest" vs. acting as management/employee advocate
• Report on progress of HR deliverables to CRT

This position is not eligible for relocation.

QUALIFICATIONS:

Please note that except where specified as preferred all points listed below are considered minimum requirements.

• 10+ years of progressively responsible HR and/or business experience with a minimum of 7 years of HR or related experience and exposure to and competence in HR functional areas
• Bachelor's Degree or equivalent work experience required.
• Proven track record for consistently meeting or exceeding quantitative goals
• Bio-tech or pharmaceutical experience a plus
• Broad HR background is helpful, but not required if other capabilities are present.

ABILITIES: Broad HR Functional/Technical Knowledge and Expertise; High Level Project Management Skills; Excellent Consultation and Influencing Skills; Demonstrated Leadership Skills

This Digital Workplace IT Solution Owner (Business Partner) position is within the Pharma Informatics team in SSF that is responsible to provide IT Services to Genentech’s Corporate Functions. Genentech’s Corporate Function IT organization interfaces with Site Services, Legal, Health Care and Compliance, Corporate Relations and HR in SSF and specifically, this position will be focused on closely partnering with business stakeholders and Informatics colleagues to deliver the IT Service to the organization with a focus on New Work Environment initiative.

Key Responsibilities

• Collaborate with the business stakeholders to design, deliver and maintain the affiliate multi-year digitally-enabled portfolio and technology roadmaps for Digital Workplace enablement

• Own the process of end to end delivery of defining, managing, implementing and supporting solutions

• Direct partners/vendors in the delivery of IT services and solutions that align with business needs

• Bring awareness of new technologies and products to business stakeholders and incorporate in to the capability and technology roadmaps as applicable

• Interface with Architects, Technical Leads and Developers to drive technical solutions, including defining/estimating work efforts, identifying milestones and managing resources

• Track progress, resolve dependencies, evaluate risks and communicate status to management and business stakeholders

• Influence and drive the team to achieve business objectives by aggressively driving solution delivery

Preferred Qualification

• BA or BS technology or business management, Master’s degree in technology or business management plus.

• Previous experience of Product Owner is a plus

• 8+ years of experience in service ownership/product ownership in digital transformation

• Business partnership, domain experience, roadmap and strategy, managing and deliver solution

• Demonstrated experience working with architects and engineers

• A passion for digital innovation and commitment to superb client experience

• Hands on experience of leading workplace technology execution as part of open office transition/New Work Environment

• Passionate about workplace technology and improving digital experience for organization

• Keeps up to date with technology trends in workplace tech is able to quickly pilot technology for value realization

• Self-starter with outstanding organizational skills and ability to manage/track multiple deliveries going on all at once along with curiosity to continually reevaluate existing designs

• Proven track record in IT roles involving business partnership, project management, directly or indirectly managing/leading teams, projects, programs or directing the allocation of resources

• Excellent executive level influencing skills, with demonstrated ability to work collaboratively and effectively with business partners, IT teams (PM’s, Tech and Business Analysts) and external services providers

• Ability to challenge conventional wisdom regarding technology refreshes and is able to communicate complex messages and trade-offs and tell a compelling story

• Familiarity / experience with the following technologies and solutions: Cloud, Mobility, Analytics, digitization, digital health, reporting, visualization tools and presentation along with Machine Learning and AI Concepts

• Strong organizational, planning and financial management skills

• Good knowledge of LEAN/KANBAN/SCRUM software development methodologies.

• Ability to translate strategies and vision into executable plans

Contractor position, part time at 20 to 30/week,

This position based in client's Hillsboro, Oregon facility, provides the opportunity to have a key role in a highly automated pharmaceutical filling and packaging facility. The site employs a highly integrated computer control system to manage plant operations and manufacturing data.  The candidate will report to the Automation IT manager in the Technology department.  The Automation IT group is responsible for enhancements, maintenance, administration, and qualification for the plant’s automation computer system infrastructure, including the Manufacturing Execution System (MES), Information Management System (IMS), Supervisory Control and Data Acquisition (SCADA), and Process Control System (PCS). 

The Project Manager will be responsible for executing the delivery of project management services to internal customers.  This position will be responsible for project management services and maintaining GMP/Non-GMP documentation, change control, computer validation testing, and departmental support processes and procedures.  They will perform assigned tasks and work to achieve company goals and department objectives.  They will do all of the above while conforming with cGMP regulations and client global regulatory standards. 

Responsibilities: 

• Deliver project goals on budget and on schedule. 
• Develop conceptual customer needs into an approved project charter. Analyze business, process and systems performance, and identify improvement opportunities.
• Develop, evaluate and manage business case and cost/benefit analyses. Provide decision support and recommendations to select best options.
• Communicate proactively with stakeholders and senior management regarding progress, issues and plans for resolution.  Develop and use project plans to coordinate participants, execute testing and track and report progress. 
• Leverage industry research and analysis; serve as advocate & role model for integrating best practices into the organization. Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals. 
• Manage site project portfolio including evaluation criteria, resource management, strategic prioritization, scenario planning, and reporting for all site operations
• Maintain portfolio management business processes, standard work, trainings, tools, and frameworks
• Participate in gap and risk analysis
• Sign documents for activities as authorized and described by client policies and procedures and job descriptions
• Support the change management system
• Troubleshoot and support the resolution and manufacturing issues by fostering effective interdepartmental and cross-functional partnerships
• Identify, design, and implement process and system improvements
• Manage competing priorities

Skills

• B.A. or B.S. degree (preferably engineering) and a minimum of 5 years of project management experience in the pharmaceutical or biopharmaceutical industry (preferably drug product manufacturing)
• Project Management Certification A Plus
• Excellent planning, organizational, and prioritization skills with the ability to multitask and adapt.
• Knowledge of cGMPs or equivalent regulations
• Ability to make sound decisions about scheduling, allocation or resources, deliverables, and managing priorities
• Ability to interpret and relate Quality standards for implementation and review
• Ability to communicate clearly and professionally both in writing and verbally
• Flexibility in problem solving, providing direction and work hours to meet business objectives
• Ability to interpret client standards and practices for implementation and review
• Ability to define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes.
• Ability to communicate effectively up and down, at all levels of the organization
• Prior experience in CAPEX project and portfolio management, business processes, and budget review.
• Manufacturing and/or Engineering environment (biotech/pharmaceutical industry or familiarity with cGMP's a plus)

Education

• B.A. or B.S. degree (preferably engineering) and a minimum of 5 years of project management experience in the pharmaceutical or biopharmaceutical industry (preferably drug product manufacturing)

The Cloud DevOps Engineer position is within the Pharma Informatics team in SSF that is responsible to provide IT Services to Genentech’s Corporate Functions. Genentech’s Corporate Function IT organization interfaces with Legal, Health Care and Compliance, Site Services, Corporate Relations and HR in SSF and specifically. This position will be focused on closely partnering with business stakeholders and Informatics colleagues to deliver the IT Service to the organization.

Key Responsibilities

• Lead delivery of technical solutions for portfolio of projects with in the team

• Provide hands-on leadership to our software engineers to design and develop solutions on AWS.

• Responsible for the technical oversight and leadership of outside vendors and international software developers working on the solutions that you own.

• Develop technology strategy, architecture, and roadmap for solutions within Genentech’s Corporate Function IT Team

• Provide application integration and solution support working collaboratively with business partners to achieve their strategic goals.

• Manage the successful implementation and delivery of solution releases, possibly spanning multiple parallel tracks.

• Responsible for the technical oversight and leadership of outside vendors and international software developers working on the solutions that you own.

• Collaborates with internal and external teams to leverage cloud platforms

• Keeps track of industry and cutting-edge technology trends, connect and foster external networking opportunities to look for new and innovative ways to do business differently

• Help instill agile product/DevOps mindset within the service delivery teams

• Track progress, resolve dependencies, evaluate risks and communicate status to management and business stakeholders.

Preferred Qualification

• BS in Computer Science

• 5+ years of experience in developing and managing software solutions

• Ability to troubleshoot across layers of the technology stack

• Experience with programming in one of the following languages – Python, Javascript, Golang and/or Java.

• Strong leadership and communication skills to work with leadership and stakeholders in executing the vision and providing content and best practices on using CI/CD services

• Ability to leverage his/her experience in delivering and supporting global information systems in an environment for a diverse and distributed user base while relying on a number of global/enterprise shared services

• Knowledge of Single Sign On (SSO), reverse proxy, firewall, servers and load balancer technologies including the new server less technology

• Familiarity / experience with the following technologies and solutions: Cloud, Mobility, Analytics, digitization, digital health, reporting, visualization tools and presentation along with Machine Learning and AI Concepts

• Relevant experience in Enterprise Software Architecture, including AWS architecture and modeling using relational databases running SQL (AWS RDS Oracle) and non-SQL stores (e.g. S3, graph databases, RDF store)

We seek a highly motivated and capable Associate Scientist to contribute to biomarker research efforts in support of Genentech’s drug development pipeline in hematologic malignancies, with a focus on cancer immunotherapy (CIT).  Specifically, this individual will design and execute laboratory experiments, and oversee laboratory work by external Contract Research Organizations (CROs), to generate data regarding disease biology, patient subsets, and the biologic effects of therapeutic agents.

The candidate should have hands-on experience with mammalian cell culture and the culture and processing of primary samples such as blood and bone marrow aspirate, and should be proficient in flow cytometry data collection and analysis. The ideal candidate will also be familiar with methodologies for DNA/RNA isolation and quantification, as well as phenotypic and functional characterization of immune cells (e.g. cytokine release assays, cell killing assays, ELIspot, multimer staining).  Expertise in human immunology, cancer immunotherapy, oncology, cancer cell signaling pathways, and translational research is highly desirable.

The successful candidate is expected to work seamlessly as part of a multifunctional team, have excellent oral and written communication skills, participate and contribute to team meetings, publish in high quality scientific, technical or medical journals, and present at internal and external meetings.

Scope of position:

The Associate Scientist will report to a Senior Scientist/Scientist in the Oncology Biomarker Development (OBD) department within the Development Sciences Division of Genentech Research and Early Development. The individual will be responsible for biomarker research efforts supporting one or more molecules and disease in the Hematology disease area.   Scope of biomarker activities will span predictive, pharmacodynamic, and prognostic biomarkers as well as surrogate response markers such as MRD (minimal residual disease). The Associate Scientist will be responsible for contributing to Genentech research into the immunobiology of heme malignancies, translating preclinical hypotheses into a clinical biomarker strategy, generating insights, performing hypothesis testing and target validation and discovery from clinical biomarker samples.

 

Job Responsibilities

• Design, conduct, and analyze laboratory experiments in the areas of cancer immunobiology and hematology
• Collaborate with scientists across different departments at Genentech to accomplish research goals
• Participate in and contribute to team meetings, such as presenting experimental plans and results
• Understand and incorporate learnings from external research through regular review of the scientific literature and attending scientific conferences; regular publication of scientific and methodological results is strongly encouraged
• Oversee laboratory work by external Contract Research Organizations (CROs)
• Become an internally-recognized thought leader in the immunobiology of heme malignancies and an internal expert resource in one or more key laboratory techniques.

Job Requirements

• Ph.D. degree in life science.
• 0-2 years of postdoctoral work, and/or work experience in the biotech/pharma industry
• A flexible mindset, with strong interpersonal, communication, and problem solving skills.
• Successful demonstration of initiative, teamwork, collaboration and technical expertise.
• Independent and creative scientist, as evidenced by a strong publication record.
• Ability to create and establish priorities, manage work plans, and meet timelines.
• Ability to identify, evaluate, implement, and become proficient in novel laboratory techniques.
• Demonstrated expertise with cell culture including primary cell culture, and the handling of rodent and human tissues such as blood and bone marrow samples
• Hands-on experience with flow cytometry data generation and analysis
• Experience with phenotypic and functional characterization of immune cells
• Familiarity with standard RNA/DNA and protein analysis techniques

Preferred

• Familiarity with next-generation sequencing (NGS) methods and immunohistochemistry techniques
• Experience with mouse models of leukemia or other hematologic malignancies.
• Experience in hematology and/or immunotherapy
• Familiarity with 3 dimensional cell culture
• Ability to perform analysis of large datasets e.g RNAseq data.

#LI-GREDNN1

We seek a highly motivated Scientist/Physician Scientist to lead biomarker development efforts in support of Genentech’s pipeline in hematological malignancies. Substantial expertise in hematology, oncology, personalized healthcare approaches, and translational research is highly desirable. The individual will be responsible for designing, implementing and leading the biomarker strategy for one or more Genentech’s products. The ideal candidate will also be familiar with methodologies and platforms used for analyzing high-content NGS data with clinical outcome, deriving scientific insights and translating them into development/diagnostic opportunities. The successful candidate is expected to work seamlessly as part of a multifunctional team, have excellent oral and written communication skills, participate and contribute to team meetings, publish in high quality scientific, technical or medical journals, present at internal and external meetings.



Scope of position:

The Scientist will report to an Associate Director/Director in the Oncology Biomarker Development (OBD) within the Development Sciences Division of Genentech Research and Early Development. The individual will be responsible for the oversight of biomarker programs of one or more early and late-stage molecules. This position will be lab-enabled.



Primary responsibilities are as follows:

• Provide exceptional scientific leadership to peers in OBD and assigned project teams (including discovery scientists, clinical researchers, bioinformatics scientists)
• Responsible for translating preclinical hypothesis into a clinical biomarker strategies for one or more projects
• Have deep scientific expertise of the subject and disease to champion the translation of novel scientific discoveries into clinical development opportunities or diagnostic platforms, such as detection of minimal residual disease.
• Participate and thrive in an interactive, team oriented culture
• Regular publication of scientific and methodological results are strongly encouraged, and scientists are expected to develop over time into externally recognized leaders in translational sciences who influence the field of personalized healthcare in oncology

Qualifications:

• PhD, MD or PhD/MD degree in a relevant scientific field (e.g. hematology, cancer biology, molecular biology, immunology)
• Ability to work with large, multi-omic data sets and familiar with techniques for exploring associations of biomarkers with clinical outcomes.
• Computational skills with statistical software packages such as R are preferred, but not essential. Experience with machine learning techniques for high dimensional data is a plus.
• Minimum of 3 years postdoctoral basic or translational research experience in either academic and/or in an industry setting
• Demonstrated record of cutting edge research as evidenced by first or senior authored publications in top tier journals
• Be able to distill complex issues and clearly articulate solutions
• Ability to collaborate, lead, influence and motivate others
• Ability to demonstrate effectiveness and growth in a fast-paced and dynamic environment
• Outstanding presentation and communication skills

#LI-GREDNN1

The Early Clinical Development (ECD) group in Oncology at Genentech is seeking a talented physician scientist to join our Cancer Immunotherapy development team to translate our preclinical discoveries into the next generation of cancer immunotherapies for patients. The ECD Oncology Group at Genentech conducts first-in-human Phase I and Phase II studies with novel agents against a variety of immunotherapy targets with a strong focus on mechanism-based biomarkers, seeking the next generation of therapies that will benefit patients.



This Assistant/Associate Medical Director will be leading a development team that is studying a novel cancer immunotherapy target as a single-agent and in combination with other immunotherapy agents in multiple solid tumors and hematological malignancies. This Assistant/Associate Medical Director will lead the design, execution, monitoring, analysis, and reporting of innovative Phase I/II clinical studies, with an initial focus on cancer immunology and novel immune-modulating agents, including studies of rational scientific combinations. Eventual opportunities to lead the development of other novel targets within our extensive oncology portfolio are also anticipated. This physician scientist will provide leadership for internal cross-functional teams in the clinical development of a novel immunotherapy target and will be the primary point of contact for communicating with external global oncology leaders, clinical investigators, and scientists. This physician scientist will directly work with research scientists in the Cancer Immunology Research group and the Oncology Biomarker Development group at Genentech, and may also work with the Genentech Partnering group on in-licensing opportunities in cancer immunotherapy.



This Assistant/Associate Medical Director will be designing and conducting efficient, interpretable clinical studies and programs that address high priority exciting questions in oncology and cancer immunotherapy that are supported by Genentech’s outstanding commitment to fundamental cancer research, its scientific leadership in cancer immunology, and its vibrant patient-oriented culture. 

Qualifications

Candidates must have an M.D. or M.D./Ph.D. with board certification or eligibility in Oncology or Hematology/Oncology.



Candidates should have an excellent scientific record with experience in laboratory-based cancer research and/or oncology clinical trials, either within an academic institution or the pharmaceutical industry, and research and/or clinical experience in Cancer Immunotherapy is preferred.



Candidates should have the desire and ability to effectively participate within multidisciplinary teams and have the ability to interact with external experts and investigators.

#LI-GREDKT1