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Date Job Title Job Level Location
10/21/19 Senior Clinical Trial Leader Individual contributor South San Francisco, California

Purpose:

 

The Sr. Clinical Trial Leader (CTL) will provide support/leadership to one or more Study Management Teams (SMTs) and/or Study Review Teams (SRTs), and provide strategic planning and organization to achieve successful study completion. The CTL will maintain full ownership of the USMA portion of a study and ensure the effective and efficient delivery of the operational aspects in accordance with the Medical Plan, The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) standards, Roche Standard Operating Procedures (SOPs), local operating guidelines and local regulatory requirements.

The CTL will  also ensure the development and maintenance of productive relationships with our customers.

 

All Roche employees are expected to effectively contribute to cross-functional collaboration and coordination and comply with all laws, regulations, policies & procedures that govern our business.

 

Role Responsibilities/Accountabilities:

 

In this position, you will be primarily accountable for consistently, effectively:

      Contributing clinical operations expertise into Medical Plans and study design

      Managing assigned clinical studies operations, and assuming accountability for such, to ensure delivery of operational activities to meet Study Plans outlined in Medical Plans

      Providing direction and/or leadership to one or more SMTs

      Providing Contract Research Organization (CRO) and other vendor oversight

      Ensuring assigned SMTs and vendor partners deliver on commitments to agreed targets

      Ensuring study adherence to budget, ICH-GCP standards, Genentech/Roche SOPs and other operating guidelines and regulatory

      requirements

      Compliantly developing and cultivating productive relationships with external partners/stakeholders

      Ensuring that risk and quality plans are robust, proactive and implemented for each assigned study

      Contributing to study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting

      continuous improvement

      Driving and making clear decisions in the project team environment

 

In this position, you will be responsible:

Operations:

  • Serve as a member of one or more global cross-functional Study Management Teams (SMTs) and Study Review Teams(SRTs) through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the Medical Plan
  • Participate in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, and PRO specifications, drug supply and biomarker/sample management plans, TMF, and CSRs. Liaise with cross-functional team members including the SMT members to solicit input
  • Draft and implement study plans, including vendor oversight, risk, quality, safety, communication
  • Support EDC and Clinical Trial Management System (CTMS) systems and data maintenance
  • Track budget, timelines, milestones, and critical study activities; identifying issues and proposing potential resolutions
  • Partner closely with Medical colleagues to provide strategic operational input on protocol feasibility
  • Provide input into the study budget and manage assigned vendor budget(s); communicate variances in actual versus forecasted spend in vendor budgets and present an action plan for resolution to the Study Management Team Leader (SMTL)
  • Participate in selection of vendors (participate in the Request for Proposal [RFP] process), in collaboration with the SMTL
  • Utilize outputs from operational analytical tools to enhance and improve study execution
  • Oversee delegated outsourced activities to ensure Contract Research Organization (CRO) and vendor delivery against contracted scope of work.
  • Contribute to study site selection and management
  • Oversee protocol, country, and site feasibility assessments
  • Assist with all activities related to site selection, contracting, set-up and maintenance
  • Partner with Site Contracts on development of site budget template and budget negotiations
  • Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness
  • Coordinate planning and execution of effective investigator meetings. As appropriate/applicable, drive agenda and content for investigator meetings
  • Ensure accuracy and timeliness of CTMS, timeline planning tools and other core systems
  • Ensure study adherence to ICH/GCP and SOPs

 

Other:

  • Stay current on relevant therapeutic knowledge and clinical research best practices
  • Participate in the evaluation of standards across one or more SMT(s)/SRT(s) with the objective of enhancing quality, productivity and efficiency
  • Provide support, mentoring and study-specific training to other USMA Clinical Operations team members
  • As appropriate, serve as subject matter expert on task forces, initiatives and various working groups; contributing to USMA and USMA Clinical Operations initiatives

Skills:

 

      Proven track record of meeting or exceeding objectives and goals

      Demonstrable abilities to work more independently (with less guidance and supervision) in strategizing, designing and overseeing local clinical study plans and projects

      Strong business acumen: knows the industry, key competitors and other marketplace factors/dynamics

      Good project and process management skills: can prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment of such

      Good communication & presentation skills: communicates in a timely, thorough and concise manner and is comfortable presenting information to others at varying organizational levels

      Strong influencing & negotiation skills

      Strong interpersonal & partnering skills: has proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams

      Financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources

      Strong customer orientation/focus

      Good computer skills, including common desktop programs

      Business travel, by air or car, may be required for internal and external business meetings

 

Background/Experience and Education:

      Bachelors Degree in a medical/science-related discipline

      Strong knowledge of ICH-GCP and other relevant standards and guidelines

      Strong knowledge of operational aspects of clinical trial management and the drug development process

      Knowledge of relevant therapeutic areas is a plus

      Experienced in managing aspects of one or more global, complex, clinical studies and generally experienced in clinical research/development

      5 or more years’ proven experience in clinical research and development

      Demonstrated experience in at least one therapeutic area relevant to the work of Genentech/Roche

      Clinical development experience in operational aspects of conducting clinical studies, including:

      Vendor/CRO management

      Participating in or leading a Study Management Team

      Implementing clinical development/medical plans

      Coordinating study level activities to deliver data for filing or publication purposes

      Project management experience including implementation of risk management plans and management of complex study budgets and resourcing plans

10/21/19 Clinical Trial Leader Individual contributor South San Francisco, California

Purpose:

 

The Clinical Trial Leader (CTL) will provide support/leadership to one or more Study Management Teams (SMTs) and/or Study Review Teams (SRTs), and provide strategic planning and organization to achieve successful study completion. The CTL will maintain full ownership of the USMA portion of a study and ensure the effective and efficient delivery of the operational aspects in accordance with the Medical Plan, The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) standards, Roche Standard Operating Procedures (SOPs), local operating guidelines and local regulatory requirements.

The CTL will  also ensure the development and maintenance of productive relationships with our customers.

 

All Roche employees are expected to effectively contribute to cross-functional collaboration and coordination and comply with all laws, regulations, policies & procedures that govern our business.

 

Role Responsibilities/Accountabilities:

 

In this position, you will be primarily accountable for consistently, effectively:

      Contributing clinical operations expertise into Medical Plans and study design

      Managing assigned clinical studies operations, and assuming accountability for such, to ensure delivery of operational activities to meet Study Plans outlined in Medical Plans

      Providing direction and/or leadership to one or more SMTs

      Providing Contract Research Organization (CRO) and other vendor oversight

      Ensuring assigned SMTs and vendor partners deliver on commitments to agreed targets

      Ensuring study adherence to budget, ICH-GCP standards, Genentech/Roche SOPs and other operating guidelines and regulatory

      requirements

      Compliantly developing and cultivating productive relationships with external partners/stakeholders

      Ensuring that risk and quality plans are robust, proactive and implemented for each assigned study

      Contributing to study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting

      continuous improvement

      Driving and making clear decisions in the project team environment

 

In this position, you will be responsible:

Operations:

  • Serve as a member of one or more global cross-functional Study Management Teams (SMTs) and Study Review Teams(SRTs) through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the Medical Plan
  • Participate in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, and PRO specifications, drug supply and biomarker/sample management plans, TMF, and CSRs. Liaise with cross-functional team members including the SMT members to solicit input
  • Draft and implement study plans, including vendor oversight, risk, quality, safety, communication
  • Support EDC and Clinical Trial Management System (CTMS) systems and data maintenance
  • Track budget, timelines, milestones, and critical study activities; identifying issues and proposing potential resolutions
  • Partner closely with Medical colleagues to provide strategic operational input on protocol feasibility
  • Provide input into the study budget and manage assigned vendor budget(s); communicate variances in actual versus forecasted spend in vendor budgets and present an action plan for resolution to the Study Management Team Leader (SMTL)
  • Participate in selection of vendors (participate in the Request for Proposal [RFP] process), in collaboration with the SMTL
  • Utilize outputs from operational analytical tools to enhance and improve study execution
  • Oversee delegated outsourced activities to ensure Contract Research Organization (CRO) and vendor delivery against contracted scope of work.
  • Contribute to study site selection and management
  • Oversee protocol, country, and site feasibility assessments
  • Assist with all activities related to site selection, contracting, set-up and maintenance
  • Partner with Site Contracts on development of site budget template and budget negotiations
  • Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness
  • Coordinate planning and execution of effective investigator meetings. As appropriate/applicable, drive agenda and content for investigator meetings
  • Ensure accuracy and timeliness of CTMS, timeline planning tools and other core systems
  • Ensure study adherence to ICH/GCP and SOPs

 

Other:

  • Stay current on relevant therapeutic knowledge and clinical research best practices
  • Participate in the evaluation of standards across one or more SMT(s)/SRT(s) with the objective of enhancing quality, productivity and efficiency
  • Provide support, mentoring and study-specific training to other USMA Clinical Operations team members
  • As appropriate, serve as subject matter expert on task forces, initiatives and various working groups; contributing to USMA and USMA Clinical Operations initiatives

 

Skills:

 

      Proven track record of meeting or exceeding objectives and goals

      Demonstrable abilities to work more independently (with less guidance and supervision) in strategizing, designing and overseeing local clinical study plans and projects

      Strong business acumen: knows the industry, key competitors and other marketplace factors/dynamics

      Good project and process management skills: can prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment of such

      Good communication & presentation skills: communicates in a timely, thorough and concise manner and is comfortable presenting information to others at varying organizational levels

      Strong influencing & negotiation skills

      Strong interpersonal & partnering skills: has proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams

      Financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources

      Strong customer orientation/focus

      Good computer skills, including common desktop programs

      Business travel, by air or car, may be required for internal and external business meetings

 

Background/Experience and Education:

      Bachelors Degree in a medical/science-related discipline

      Strong knowledge of ICH-GCP and other relevant standards and guidelines

      Strong knowledge of operational aspects of clinical trial management and the drug development process

      Knowledge of relevant therapeutic areas is a plus

      Experienced in managing aspects of one or more global, complex, clinical studies and generally experienced in clinical research/development

      5 or more years’ proven experience in clinical research and development

      Demonstrated experience in at least one therapeutic area relevant to the work of Genentech/Roche

      Clinical development experience in operational aspects of conducting clinical studies, including:

      Vendor/CRO management

      Participating in or leading a Study Management Team

      Implementing clinical development/medical plans

      Coordinating study level activities to deliver data for filing or publication purposes

      Project management experience including implementation of risk management plans and management of complex study budgets and resourcing plans

10/21/19 Process and Compliance Lead Basel, Basel-City

At Roche, we believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are ambitious in both decision and action. And we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

As a senior member of the team, you will be joining a transforming team driving transformation into the business. With the introduction of content reuse and automation (CR&A), you are willing to challenge the status quo to shape the future of medical writing at Roche. You embrace customer-centricity to prepare, introduce and embed the new way to create content that forms the regulatory submissions transforming patients’ lives. We would like to diversify our skills in the team, so we welcome individuals with agile mindset, who may be IT savvy, has knowledge of structured content management, or have knowledge of LEAN methodology to join our team. 

The jobholder will collaborate closely with senior stakeholders across the business, including senior members from other functions that contribute to the delivery of content, Global Process Owners and Business Process Owners, the QPPV and members of working groups and governance bodies. This is an influential role in sustainment of capabilities, continuous improvement and ongoing process innovation in the regulatory content management arena at Roche.

 

Primary Responsibilities and Accountabilities:

  • Lead design, development, maintenance, support, and continuous improvement of PDRD processes/capabilities, ensuring that they deliver high quality and timely regulatory documentation in line with evolving regulatory authority and internal stakeholder requirements.
  • Working in close partnership with subject matter experts (SMEs) in PDRD and broader organisation, accountable Global Process Owners and Business Process Owners. Serving as the principal SME for the assigned area(s) of process as required.
  • Maintaining awareness of external trends and anticipating future requirements or opportunities.
  • Identifying, sharing, and promoting good practice and innovation, both with regard to the assigned process(es) and the utilisation of process improvement methodologies:  Providing guidance to ensure process continuity, consistency and alignment.
  • Potentially serving as a Global Process Owner and/or Business Process Owner for one or more assigned process(es).
  • Building and strengthening relationships within Roche (e.g. within PDR, with PDS sub-functions, other PD Functions, REDs, GPS, Affiliates  and working groups) and with Roche partners
  • Collaboration and close interface with internal policy governance bodies/stakeholders (e.g., EU QPPV, Drug Safety Committee, GCP and GVP Council, quality network etc.) in adapting PDRD processes in line with evolving Regulatory Authority requirements and business needs.
  • Providing input/leadership into activities designed to promote continuous improvement, and gather broad organisational input to potential process improvements and ideas or opportunities for further innovation.
  • Providing input/leadership to project prioritisation and capacity management activities.
  • Ensuring critical process requirements are defined as an input to the development of associated tools and technologies, in partnership with internal and external informatics and IT system roles and providers, where relevant.
  • Responsible for providing relevant input to the communication, training, implementation, follow-up and feedback, relating to assigned processes.
  • Promoting a culture of continuous process improvement, innovation and a solution-orientated mind set.
  • Networking with internal and external groups to understanding their needs and ideas; identifying and anticipating solutions and working collaboratively to find solutions

    .

Education/Qualifications:

  • BSc or equivalent in relevant scientific discipline
  • Relevant experience in GVP and/or GCP-related role (typically 5+ years of experience)

     

Experience, Skills, Knowledge

  • Good knowledge of regulatory documents to develop and maintain licenses and a broad understanding of pharmaceutical drug development
  • Good knowledge of regulatory GVP and GCP requirements and guidelines specific to the regulatory documents published by the major global Health Authorities (e.g. FDA, EMA, MHRA, etc.)
  • Strong interpersonal and communication skills in a global environment
  • Experience of influencing broad groups of stakeholders, adopting a range of influencing styles and/or communication techniques, and negotiating at various levels/matrix environment to achieve expected outcomesAbility to operate effectively in, and lead as needed, multi-functional matrix teams
  • Excellent written and verbal communication skills (must be fluent in English) and the ability to present and critically discuss data in relation to its significance and impact on the processes in both internal and external discussions.
  • Planning, Co-ordination and Organisation: possesses excellent organisational and project planning skills
  • Excellent attention to detail and commitment to deliver high quality
  • Prior experience in project management and/or process improvement is desirable
  • Ability to meet tight deadlines and to work concurrently on several projects

Locations: We are hiring several people. This role can be based either in Basel, Welwyn, South San Francisco or Mississauga

Applications: Ideally, please specify at the beginning of your cover letter your preferred location

Roche embraces diversity and equal opportunity in a serious way. We are committed to building teams that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

If you still have questions then please check our FAQs and videos on careers.roche.ch/faq.

Roche is an equal opportunity employer.

10/19/19 Postdoctoral Fellow, Microchemistry Proteomics & Lipidomics Individual contributor South San Francisco, California

The Discovery Proteomics group is seeking a postdoctoral fellow to investigate the fundamental aspects of enzymes in the ubiquitin system using quantitative mass spectrometry.  The research will focus on implementing quantitative approaches and cutting edge instrumentation to probe post-translational signaling networks, with an emphasis on the ubiquitin system, cancer signaling pathways and cell death regulation.  The successful candidate should be innovative and capable of working independently to establish methods, carry out experiments, and perform computational data analysis.

https://www.gene.com/careers/university-and-early-career/postdocs

10/18/19 Senior EH&S Specialist Individual contributor South San Francisco, California

This individual will support the effective use of the EHS Management System for the Biochem Business Unit (BBU) in SSF. This person will, under the direction of the BBU EHS Manager, be responsible for the execution and supervision of ongoing environmental, safety and health programs for the site to ensure a safe environment in accordance with the goals and objectives of the BBU.

Responsibilities

  • Develop, implement and monitor company-wide environmental health programs in a variety of areas such as chemical, biological and/or radioactive waste management, effluent emission monitoring/reporting and emergency response procedures.
  • Interpret EH&S standard operating procedures (SOPs) for employees to ensure consistent and compliant application of policies and programs throughout the company.
  • Perform regular audits of SOPs and EH&S policies and revise as necessary to comply with federal, state and local requirements.  Develop and initiate communications to ensure revisions are implemented.
  • Conduct routine audits to identify changes in operations that may affect the conditions of environmental permits and licenses.  Notify management of situations requiring additional investigation, and provide investigational support as requested.
  • Conduct safety hazard evaluations through facility and equipment inspections.  Perform analysis, as necessary, to identify root causes and make recommendations on corrective to management.
  • Conduct EH&S training programs and revise instructional materials as needed. 
  • Assist in the development of new training materials and programs and in the development of tools to analyze and improve training effectiveness.
  • Participate in regulatory agency inspections by answering questions, and providing reports and documentation as directed by department management.
  • Monitor budget expenditures by maintaining accurate records in department database and/or expense reporting spreadsheets.  Perform periodic analyses to identify potential budget problems and present information to management.
  • Assist senior management, as requested, to develop portions of the department budget.
  • Perform routine operational support duties such as preparing forms, filing regulatory documentation and maintaining department logs as necessary.
  • Assist with special, short-term projects as directed by the manager of the EH&S department.
  • Complete purchase requisitions for routine supplies and equipment.

Requirements

  • Bachelor’s Degree in a life science discipline
  • 6+ years environmental health and safety experience in a bio-medical research or manufacturing environment
  • 2+ years EH&S experience in a cGMP Pharmaceutical or Biotech manufacturing environment.
  • Hazardous material certifications.
  • Ability to perform routine tasks without direct supervision, and able to complete new assignments with general instructions.
  • Demonstrate good verbal and written communication skills.
  • Ability to read and interpret complex regulatory documentation.
  • Ability to understand and follow verbal and written instructions (including SOPs).
  • Demonstrate excellent organizational skills including the ability to prioritize own work to meet established timelines and department goals.
  • Demonstrate strong presentation skills.
  • Demonstrate strong analytical problem solving skills.
  • Demonstrate excellent interpersonal skills, including the ability to resolve problems using poise, tact and diplomacy.
  • Demonstrate proficiency in standard business software applications.

Work Environment/Physical Demands/Safety Considerations

  • Work in standard office environment.
  • May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn.  No make up or jewelry can be worn when working in the clean room environment.
  • When working in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.
  • May be exposed to hazardous materials and chemicals.
  • Ability to wear a negative pressure Air Purifying Respirator and an SCBA. 
  • Ability to work around hazardous, radioactive, and potentially infectious materials and waste.
  • Ability to lift 25 pounds.
10/18/19 Sr Clinical Trial Leader South San Francisco, California

In this position, you will be primarily accountable for consistently, effectively:

  • Contributing clinical operations expertise into Medical Plans and study design
  • Managing assigned clinical studies operations, and assuming accountability for such, to ensure delivery of operational activities to meet Study Plans outlined in Medical Plans
  • Providing support,  direction and/or leadership to one or more SMTs
  • Providing Contract Research Organization (CRO) and other vendor oversight
  • Ensuring assigned SMTs and vendor partners deliver on commitments to agreed targets
  • Ensuring study adherence to budget, ICH-GCP standards, Genentech/Roche SOPs and other operating guidelines and regulatory requirements
  • Compliantly developing and cultivating productive relationships with external partners/stakeholders
  • Ensuring that risk and quality plans are robust, proactive and implemented for each assigned study
  • Contributing to study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting continuous improvement
  • Driving and making clear decisions in the project team environment

 

In this position, you will be responsible to:

  • Serve as a member of one or more global cross-functional Study Management Teams (SMTs) and Study Review Teams (SRTs) through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the Medical Plan
  • Participate in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, and PRO specifications, drug supply and biomarker/sample management plans, TMF, and CSRs. Liaise with cross-functional team members including the SMT members to solicit input
  • Draft and implement study plans, including vendor oversight, risk, quality, safety, communication
  • Support EDC and Clinical Trial Management System (CTMS) systems and data maintenance
  • Track budget, timelines, milestones, and critical study activities; identifying issues and proposing potential resolutions
  • Partner closely with Medical colleagues to provide strategic operational input on protocol feasibility
  • Provide input into the study budget and manage assigned vendor budget(s); communicate variances in actual versus forecasted spend in vendor budgets and present an action plan for resolution to the Study Management Team Leader (SMTL)
  • Participate in selection of vendors (participate in the Request for Proposal [RFP] process), in collaboration with the SMTL
  • Utilize outputs from operational analytical tools to enhance and improve study execution
  • Oversee delegated outsourced activities to ensure Contract Research Organization (CRO) and vendor delivery against contracted scope of work.
  • Contribute to study site selection and management
  • Oversee protocol, country, and site feasibility assessments
  • Assist with all activities related to site selection, contracting, set-up and maintenance
  • Partner with Site Contracts on development of site budget template and budget negotiations
  • Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness
  • Coordinate planning and execution of effective investigator meetings. As appropriate/applicable, drive agenda and content for investigator meetings
  • Ensure accuracy and timeliness of CTMS, timeline planning tools and other core systems
  • Ensure study adherence to ICH/GCP and SOPs

 

Other:

  • Stay current on relevant therapeutic knowledge and clinical research best practices
  • Participate in the evaluation of standards across one or more SMT(s)/SRT(s) with the objective of enhancing quality, productivity and efficiency
  • Provide support, mentoring and study-specific training to other USMA Clinical Operations team members
  • As appropriate, serve as subject matter expert on task forces, initiatives and various working groups; contributing to USMA and USMA Clinical Operations initiatives
10/18/19 Snr Quality & Compliance Mgr Individual contributor South San Francisco, California

Description:

This position serves as an important conduit to the broader organization to ensure a culture of compliance through well-thought out, actionable, aligned and achievable related processes and procedures. Given the nature of the group's work, the incumbent will communicate and interface with a host of internal cross-functional partners, both within gRED and other Roche functions, identifying areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance.



Responsibilities:

 

  • Partner with other departments interacting with Global & Regional functions including, but not limited to: Drug Safety, Quality Assurance/ Risk Management, PD Clinical Operations, Healthcare Law, Corporate Group & Risk Advisory, Medical Affairs to ensure appropriate cross-functional SOPs, Policies or Work Instructions are in place.
  • Collaborate with Genentech Early Clinical Development (ECD), Quality and Compliance Office (QCO) on the implementation and maintenance of the Functional Quality Management System (QMS) and its related documents, in alliance with the Quality principles outlined in the Global Roche GCP /GVP Quality Manual.
  • Provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations and tools intended for use in clinical trial conduct and/or regulated drug development activities.
  • Serve as a key contact for communicating controlled document and policy changes within/across gRED organization.
  • Serve as a consultant to management and act as an internal/external spokesperson for the organization on matters pertaining to policies, quality plans, objectives and business goals.
  • Proactively research, evaluate and make recommendations associated with evolving laws and regulations.  Benchmarks and stays abreast of other industry and marketplace developments and best practices.
  • Contributes to annual QCO goals and objectives and contributes to ongoing continuous improvement.
  • Effectively integrates compliance risk/context and business knowledge to address unusually complex problems. Keeps current in the area of healthcare compliance, GCP, GVP, company policy and procedures.
  • Proactively identifies and addresses compliance issues and risks.
  • Recommends and drafts new or amended policies & SOPs in support of regulatory policy, law and regulations while specifying actual or potential implications to existing business operations, procedures and practices.
  • Independently leads and/or participates, without appreciable direction, on internal committees as a decision-maker or is lead reviewer in a complex process.
  • Acts as a point-of-contact for ECD/gRED policies, SOPs and audits. Responds to inquiries from within and across the organization and may participate as the department’s representative in cross-functional committees.
  • Prepares regular reports for management and cross functional teams.
  • As assigned, assists with other department duties and/or projects.
  • Where applicable, manages outside vendors to ensure on-time, on-target and within-budget deliverables

Qualifications:

 

  • 12 - 15 Years with Bachelor's degree of medicine/pharmacy/other healthcare disciplines.
  • 10 - 13 Years with Masters experience in pharmaceutical drug development, preferably in regulatory compliance and/or quality responsibilities within a drug development organization.

Skills:

  • Has impeccable ethics. Demonstrates, or has proven abilities to demonstrate, Roche Values & Leadership Commitments
  • Strong influencing skills: proven track record and experience building and cultivating relationships with key partners and stakeholders across organizational levels
  • Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
  • Strong verbal and written business communication skills: highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications
  • Strong process-orientation: has proven effectiveness in identifying, developing and implementing scalable/sustainable process and other continuous improvements to achieve organizational efficiencies and increase effectiveness
  • Exercises sound and independent judgment in methods, techniques and evaluation criteria for obtaining results.
  • Highly self-motivated, well organized, and able to develop alternative solutions to issues.
  • Thinks “outside of the box” for solutions. Applies creative problem-solving and appropriate business solutions to effectively address compliance risk.
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment of such.
  • Strong business acumen: understands how the business “works” and demonstrates consistently effective “navigation” across the organization
  • Desirable, but not required: Development of Systems/SOPs for an R&D Organization, experience in implementation of new processes, proven success facilitating change within a complex organization.
  • Working knowledge of GCP/ICH and QA issues within a global pharmaceutical organization.
  • Basic understanding of numerous clinical development functional areas.
  • Ability to travel

#LI-GREDKM2

10/18/19 Associate Program Manager South San Francisco, California

GENERAL POSITION SUMMARY/PURPOSE:

In this exciting role within the I2ONE (immunology, infectious disease, ophthalmology, neuroscience, established products) Genentech Regulatory Program Management team you will participate in, develop, and implement regulatory strategies to facilitate product development.  While you are expected to perform your responsibilities with supervision, you will be given the opportunities to take the lead on different projects per your experience and background. 

Genentech, a member of the Roche group, has one of the richest and most diverse pipelines in the industry. The entrepreneurial spirit and inventiveness of our founders still defines our culture; a culture that encourages innovation and bold steps as vital partners to rigorous science. As you set off on the next leg of your regulatory career journey, explore Roche. Go ahead. Make a change. Make a difference.

PRIMARY DUTIES AND RESPONSIBILITIES:

  • Participates as a standing member in the Regulatory Affairs Functional Team (RAFT) for assigned product development projects to help ensure effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution.
  • Assists relevant Regulatory Leads with their interactions, communications and planning with various other cross-functional teams.  
  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned therapeutic areas and projects.
  • As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects
  • Participates in the development and implementation of the cross-functional regulatory strategy for each project or related assignment.
  • Documents meetings, teleconferences and other interactions/communications with regulatory authorities
  • Supports Regulatory Leads in providing internal teams with direction on regulatory authority interactions
  • Helps manage project plans and timelines for assigned projects.
  • Analyzes data, the regulatory environment and business objectives to advise others on applicability of new or existing regulations and guidelines.

QUALIFICATIONS & EXPERIENCE:

  • Bachelor’s Degree required (life sciences disciplines strongly preferred)
  • Advanced Degree in related field is preferred
  • Some relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing is strongly preferred
  • Knowledge of US regulations, processes and issues in drug/biologics development. Sound understanding of GxP and ICH guidelines. 
  • Strong project management, organization and time management skills: has a track record of consistently meeting or exceeding assigned goals and objectives
  • Good verbal communication, influencing and negotiation skills: works well with and through others
  • Strong written communication skills
  • Good judgment and decision-making skills: knows how to make trade-off decisions while balancing ethics and efficacy
  • Demonstrated orientation to teamwork: has been effective in the past working in cross-functional teams

#LI-PDAB1

10/18/19 Senior Instrumentation Technician, Site Services South San Francisco, California

The responsibilities for this position at this level may include, but are not limited to:

  • Perform calibrations, repairs, and maintenance of analytical systems, laboratory instruments and analyzers.
  • Installation, calibration, troubleshooting, and modification of analytical systems, laboratory instruments, and analyzers.
  • Collection and organization of technical data from equipment manufacturers, equipment users, and engineering personnel.
  • Timely completion of tasks and work orders with appropriate documentation according to Standard Operating Procedures, applicable standards, guidelines, practices, and policies.
  • Safe operation of tools and shop equipment, and safe execution of work in the field.
  • Utilize skills and experience to achieve the safe and accurate completion of tasks on their assigned shift in support of plant operations.
  • Utilized computer skills to navigate and use corporate intranet and related applications, CMMS/CCMS, and standard word processing and spreadsheet programs.
  • Ability to follow and execute lock out procedures.
  • Assist in the creation or modification of technical documents.
  • Escort vendors in need of lab access to preform assigned calibration and maintenance work.  Ensure vendors provide complete maintenance documentation upon work completion.
  • Review and process external vendor calibration, PM, and repair documentation per established procedures.
  • Assist with identification and purchase of spare parts.
  • Support utilities in a cGMP/cGXP environment, while minimizing instrumentation and equipment downtime.
  • Ability to interact and communicate appropriately with Manufacturing, Quality, Technology, Engineering, and other departments to ensure satisfactory performance of instruments and systems.
  • Represent Instrumentation on multidisciplinary project teams and make presentations as required.
  • Assistance with systems start-up and validation.
  • Lead and train lower level crafts persons in skills necessary to become proficient. 
  • Assist management in task / personnel coordination.
  • Attend factory training for equipment to be supported, maintained, or calibrated.
  • Provide expertise in the creation or modification of technical documents.
  • Other tasks as assigned by Instrument Services management.

Requirements:

Education and Experience:

  • High School Diploma or GED and one of the following:
    • Completion of an Instrumentation or Electronics Engineering (2-year) curriculum at a technical school with three years’ experience as an instrument or electronics technician.
    • AA/AS Degree in a related science or engineering major with three years’ experience as an instrument or electronics technician.
    • Completion of equivalent military training with three years’ experience as an instrument or electronics technician.
    • Five years in instrumentation and/or analytical instrumentation or a closely related job.
  • Ability to read and interpret P&IDs, engineering documents, and schematics.
  • Ability to build and repair equipment.
  • Must be customer service oriented with good oral and written communication skills, and have pleasant telephone mannerisms.
  • Must be organize and dependable.
  • Must have good attention to details and problem-solving skills.
  • Must be proficient in coordinating tasks.
  • Strong interpersonal / customer service skills are a must.
  • Ability to work with minimum or no supervision.
  • Ability to move from one service call to the next.
  • Ability to lift up to 50 pounds.
  • Ability to navigate and use corporate intranet, applications, software, standard word processing, and spreadsheet programs.
  • Highly skilled in one trade discipline; knowledge and application of three others.
  • Thorough knowledge of the fundamental electrical, mechanical, physical, and operating principles of process instrumentation and systems.
  • General knowledge of cGMP and GLP practices.

Job Hazards:

  • Working with/around various chemicals (e.g., acids and bases), solvents, pressurized systems, compressed gases, and biological materials (Recombinant DNA).
  • Work in environments that may include low, medium, or high voltages.
  • May work at elevated heights.
  • Work with energized systems and working in close proximity to moving equipment.

10/18/19 Medical Device / Combination Product Process Engineer Individual contributor South San Francisco, California

Executive Summary

The Senior Process Engineer will be responsible for providing drug delivery device  production innovation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at Genentech.

The candidate has in depth experience in high volume manufacturing processes and methodologies and leads process development to support clinical and commercial production activities within Genentech’s device development programs, including internal engineering partners and external design/development partners and component suppliers.

The Senior Process Engineer will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems.

The candidate will work with limited direction and may provide guidance and coordinate work activities of other personnel.

The work is reviewed with a focus on long-term perspectives, as the candidate establishes his/her own work priorities and timelines.

Job Responsibilities

Quality Systems Compliance:

  • Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
  • Use (and create and implement, if necessary) local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices.
  • Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
  • Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
  • Ensure compliance of training to PQS and job-related requirements.

Design Control:

  • Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
  • Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
  • Participate in hazards analyses and design assessments and reviews.
  • Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.

The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization.  This objective will be accomplished by executing activities in the areas of:



Process Engineering:

  • Use of state-of-the-art technology to lead process development to enable clinical and commercial production in our netowrk worldwide.
  • Create leading-edge mechanical drug delivery devices and architects their high-throughput assembly
  • Regularly interact at a detailed technical level with design engineers, equipment and production engineers.
  • Provide engineering tetchnical leadership to internal cross functional team and external development partners and component suppliers.

Qualifications

Education and Industry Experience

  • B.S, M.S, or advanced degree in Engineering, with preference for Mechanical Engineering, or the equivalent.
  • At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
  • In depth experience in high volume manufacturing processes and methologies, with an emphasis in plastic molding and mechanical assembly is expected.
  • Demonstrated success in project planning, resource management, liaison with engineering and manufacturing resources in other countries is critical.
  • Hands-on experience working with control systems to be used in production and batch release. 
  • Strong expertise with statistical handling and interpretation of data, technical report writing and reviewing. 
  • Familiarity with risk management tools; develop FMEAs of the products and ability to assess changes, non-compliances, etc., with risk assessment methods.

Technical Knowledge

Strong skills in relevant modeling and design tools, design controls and/or statistical analysis. 

For example:

  • Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
  • Device Design: CADD (Solidworks, AutoCad), Design for Manufacturability, Molding.
  • Full data and statistical analysis (JMP, Minitab) and Design of Experiments, and providing detailed review of data with an emphasis on statistics.
  • Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, User Requirement Specifications (URS), Factory/Site Acceptance Testing (FAT/SAT), test protocols, technical reports, control systems to be used in production and batch release and risk management tools (methods, FMEAs, non-compliances, etc)..
  • Six Sigma (Green/Black Belt): DMAIC and DFSS

Interpersonal Skills

  • Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., validation, quality, and program management) and collaborative environment is very desirable.

     
  • Excellent oral and written communication skills are required. 
  • Able to work with external design/development and production partners is also highly desirable.
  • Highly organized and detail oriented.
  • Excellent leadership skills.
  • Demonstrated success in project planning, resource management, and liaisoning with engineering and manufacturing resources in other countries.

Training Requirements

Core training is mandatory and must be completed within the allotted time frame beginning with on-board date.  Initial training requirements are listed in this section.  (Confirm role)

PTD DEV: Process Engineer 30

PTD DEV: Process Engineer 60

PTD DEV: Process Engineer 90

Additional training to enhance Core requirements may be assigned as elective courses.  These elective courses are deemed essential to performing the job duties related to this position.

10/18/19 Business Systems Analyst Individual contributor South San Francisco, California

Job Description

Global Technical Development (PTD) is an organization integral for the mission of Roche to develop meaningful medicines for patients. Therefore, PTD actively collaborates and develops innovative technical solutions to bridge early-stage, late-stage and commercial product needs.

PTDO Informatics Team is responsible for a broad range of IT services and support across small and large molecule technical development, device development, analytical sciences, business operations and supply chain in PTD. We provide lab information management systems, data management solutions and web applications to support PTD functions.

POSITION

Reporting to the Principal Systems Manager of Informatics, the position will be accountable for client services, IT vendor management, business analysis, collecting new demand, coordinating and executing software upgrades, lab IT systems operational support for both GMP and non GMP IT platforms, defining business requirements for new/enhanced functionality, maintenance of the system configuration and associated documentation, and implementation support. The incumbent will work closely with Roche Global Informatics services and Pharma Informatics to deliver quality services. He/she must be customer-service oriented, sensitive to the IT needs of the client groups and focused on vendor management.

RESPONSIBILITIES

  • Under the supervision and direction of Principal Systems Manager and senior team members of PTDOI execute on IT/Informatics support requests which come from lab space. Be the point person for scientific users to ensure IT systems are meeting their business needs.
  • Work closely with scientific staff to understand their information management needs, assist in collecting new demand/new requests. Analysis of new requests and do scope analysis, preparation of proposals and SOW’s, vendor and COTS solution evaluation and work with IT manager to define implementation strategy and plan to roll out new demand.
  • Work on service requests and collaborate with informatics/ infrastructure personnel to deliver on IT/informatics needs. 
  • Maintain GMP IT systems in their validated state as IT system owner. Evaluate and assess need for change requests to make changes to validated systems. Work with quality and validation leads to draft, review and execute validation deliverables and test scripts.
  • Experience in handling multiple requests/projects that require interacting with user community and technical teams. 
  • Create direct channels of communication to software and application developers that get the job done without constant managerial interjection
  • Demonstrated experience in providing IT support and solution implementation in scientific domain.
  • Develop scope documents, determine and document User/ Business requirements/Narrative Use Cases, User Stories for business processes, produce end user documentation and training materials.
  • Act as a coordinator to track, plan and deliver on IT tasks. Provide regular project progress and status to IT management and business stakeholder/interested parties.

     

REQUIREMENTS

  • Bachelor’s degree in life science, computer sciences, engineering, business or a related discipline.
  • Five years working as a BSA providing informatics solutions to business problems, developing and managing IT systems with a focus on IT solution delivery, quality IT support and client services in biotech, pharmaceuticals, medical device, diagnostic, management consulting or other relevant industry.
  • Individual with excellent customer relationship and IT vendor management skills with an IT delivery service-minded attitude. 
  • Demonstrated experience collaborating effectively across multiple IT functions and customer groups.
  • Desired experience with digital transformation projects and cloud based solutions.
  • Demonstrated experience managing lab software for scientific domains including managing software and hardware requirements, software configuration, knowledge of networks, and lab instrument installation. 
  • Working knowledge of software platforms and instruments used in GMP Quality Control Laboratories, pharmaceutical manufacturing, applicable FDA guidance, and 21 CFR.
  • Hands-on experience with ELN (preferably IDBS and Benchling), Template development, life science platforms like Biovia, Chemaxon or Dotmatics is required.
  • Hands on experience with instrument controllers like Chromeleon, empower a plus along with support of Mass Specs, LC and HPLC’s is desired with focus on data storage, archiving and data retrieval.
  • The successful candidate will be a strong team player, proactive, outgoing and detail-oriented with excellent organizational & follow up, problem-solving and written/verbal communication skills. 
10/18/19 Principal Services Reliability Engineer Individual contributor South San Francisco, California

 As a core member of the Roche Science Infrastructure (RSI) team, the service reliability engineer will be responsible for developing and maintaining interoperability and scalability of the services in RSI. Working closely with other members of the RSI team, Enterprise Operations and Engineering groups, the successful candidate will rely on their experience, knowledge and expertise to implement end to end continuity, functionality and load testing for global RSI integrated services that should be fault-tolerant and distributed providing a consistent and reliable user experience.  In this role the candidate will be responsible for understanding how services interact and depend on one another to engineer and automate away operational effort and complexity, providing proactive identification and mitigation of operational risks. The successful candidate will also be responsible for providing expertise in the enhancement of current and future RSI services, providing guidance on best practices derived from the testing, scaling and monitoring the capabilities they develop. Recognized as an expert in the field, they will provide technical consultancy to other members of Infrastructure Services, with demonstrated complex problem solving abilities. Some experience in mentoring and leading others in small team environments is highly desirable. The position is global and may be placed in one of several geographic locations.

 

Main responsibilities are:

  •  Develop meaningful metrics for performance, availability, latency and efficiency to build an overall picture of service health through continuous testing & monitoring. 
  • Support frequent incremental service updates and improvements with meaningful tests of function, load, performance, and consistency of result/outcome. 

  • Contribute and work with other engineers to create and maintain reusable tools that are applicable across services.

  • Maintain current development/test environment for testing tools and enhancements both on-prem and cloud based.

  • Work closely with other members of the RSI team ensure that the continuous monitoring and pre-emptive action is optimally used across the services offered by RSI (network, I&AM, tiered storage, containers, public cloud, etc.).

  • Apply software engineering to remove toil through automation, looking to reduce operational burden, enhance consumer experience and apply continuous improvement.

Qualifications:

 The principal Services Reliability Engineer will be an experienced IT professional. With a Bachelor’s degree (advanced degree preferred) in a relevant field of technology, science or business and possessing the following qualifications:

  •  5-10 years of experience in providing scientific services monitoring & operations.  Experience with advanced monitoring tools (e.g. Zabix, XdMod) highly desirable.
  • In-depth knowledge of tool chains and analytics capabilities for operations.

  • Experience with developing, deploying and using, non-intrusive monitoring and anomaly detection agents and methods. 

  • Experience in one or more of the following programming languages: Go (golang), Python, C, C++.

  • Machine learning experience in modeling operational performance highly desirable.

  • Knowledge of configuration management tools and tool chains (e.g., Ansible, Jenkins).

  • Expertise in debugging and optimizing systems, and automating routine tasks. 

  • Interest and expertise in designing, analyzing and troubleshooting distributed systems and APIs. 

  • Good organization skills to balance and prioritize work, and ability to multitask.

  • Good communication skills to communicate with support personnel, customers, and managers.

  • Experience in applying DevOps principles and culture highly desirable.

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10/18/19 Principal Security Product Specialist - Personalized HealthCare Informatics (PHC IX) Individual contributor South San Francisco, California

Principal Security Product Specialist - Personalized HealthCare Informatics (PHC IX) 

The power of data at scale has transformed almost every industry, personalizing experiences in many aspects of our lives. Yet in healthcare we’ve only scratched the surface. At Genentech and Roche, we are accelerating the use of data insights and digital technologies to make significant strides to reach the full potential of personalized healthcare. We are seeking mission-driven, ardent, self-starting, creative individuals to join us in this effort.  

The Principal Security Product Specialist will have the responsibility for design and development of the end-end security related solutions for deployment of PHC Applications in the cloud and on-premises. This role will be part of the Pharma PHC IX/Technology Team that provides global technology solutions to enable the Pharma PHC Vision and Strategy. The Principal Security Product Specialist will partner with stakeholders in multiple groups to design and develop the security solutions for PHC Infrastructure for Roche/Genentech’s current and future PHC needs. The goal will be to build and support most reliable and scalable security solutions to support PHC Solutions and applications meeting compliance with regulatory requirements. The PHC Platform will support applications in the areas of Advanced Analytics, Digital Health, Imaging and Data management for Exploratory to Clinical Trials to Clinical Settings. This person will work very closely with key stakeholders within the PHC Center of Excellence and other cross functional teams in GIS to build Information Technology security strategy with the PHC COE strategy and portfolio.

We expect the Principal Security Product Specialist to be a passionate business and product advocate within IT, with proven analytical capabilities. The Principal Security Product Specialist must be an effective negotiator, leader and communicator in working with Roche/Genentech’s IT cross-functional teams as well as other stakeholders and vendors. The ideal candidate will be a self-starter with a passion for innovative technologies, a high level of flexibility, and commitment. The Principal Security Product Specialist will join our diverse community of smart, fun, wholehearted, and engaged informatics professionals from various functional areas. This person will share our community values of passion, courage, integrity, and gratitude -- all in-service of our mission, “doing now what patients need next.”

Responsibilities:

As Principal Security Product Specialist in PHC Pharma IT/Technology team, you will:

  • Partner closely with key stakeholders from PHC Center of Excellence and corresponding Pharma IT Groups and Global Infrastructure and Solutions(GIS) to prototype, design and implement security solutions to accelerate the fulfillment of the business strategic vision and protect Roche assets from all types of threats and adversaries.

  • Be able to source and identify emerging security technology trends from multiple internal and external sources and assess relevance. Translate and implement trends into short-term and long term security capabilities.

  • Oversee and facilitate the evaluation and selection of security technology and product standards, and the design of security standard configurations/implementation patterns

  • Work  with IT Quality, IT Security and Governance other Business partners to ensure that the application infrastructure is designed to comply with pharmaceutical regulations and GxP requirements.

  • Security product specialist will build and secure systems from external, internal threat feeds, build behavior analysis trends and develop security analytic systems to track down, stop and/or prevent malicious activities, security violations, vulnerabilities and other threats. 

  • Ensure that Roche PHC  assets information assets are secured. Security producty specialist will work with security teams including infrastructure, engineering, operations, product development and incident response team to ensure that deployed security solutions are uptodate and meet Roche security standards.

  • Design and build security monitoring solutions for detection, protection and response include IDS/IPS, malware sandbox, packet capture, netflow tools, Web Application firewalls, Real Time Application Protection systems, Antivirus, log management, SIEM, Enterprise Detection and Response and Next Generation Antivirus

  • Research emerging technologies and maintain awareness of current security risks in support of security enhancement and development efforts.

  • Lead initiatives to develop and build security utilities and tools that will enable others to operate more efficiently and securely in cloud environments

Qualifications:

  • BA/BS in Business, Information Systems, Computer Science or a relevant area of study required

  • Minimum 8 years of related work experience in Security Engineering, Privacy & Risk Management

  • Understand products and security services available from multiple Cloud Providers such as AWS, AZURE, GCP and other vendors to map those products and services to address IT and Security needs

  • Demonstrated experience automating security controls (desired languages: Shell scripting, Python)

  • Demonstrated experience supporting security and/or privacy audits

  • In-depth experience in managing information security and privacy risks and threat modeling

  • In-depth experience in vulnerability handling pre and post-market

  • In-depth experience in system and cloud infrastructure hardening

  • Experience hardening the services and products available from various cloud providers  and partners e.g. Teradata, SageMaker, ECS, EKS, GKE, Palo Alto, Imperva, Redshift, Dataguise, ClamAV etc. and ability to propose fit-for-purpose services to meet requirements

  • Hands-on experience in designing infrastructure as Code, building  DevSecOps pipelines and automation using CI/CD toolsets such as GIT, BitBucket, Jenkins, Ansible, Terraform etc. and Container platforms such as Docker, Kubernetes.

  • Good understanding of the application landscapes used in Research  environments such as as Imaging Solutions, Advanced Analytics Tools, Data Lakes,  Landing Zones including High speed Data Ingestion from Internal and external data sources

  • Strong background in working with various operating systems including various flavors of Linux (RedHat, Ubuntu, CentOS, SuSE) and MicroSoft Windows Servers

  • Good understanding of Regulatory and GxP requirements for working in Healthcare sector including HIPAA, GDPR,  HITRUST, ISO-27001 etc.

  • Certifications are a plus: SANS GIAC (GCIH, GPEN, GCIA, GCFA and others), CEH, CISSP, CISA, CISM, LAISO27001

  • Implementation of SaaS based solutions  to achieve continuous compliance and Policy enforcements thru BOTs, Security and vulnerability monitoring, log aggregation etc. with  good understanding of tools such as Splunk, Dome9, Qualys etc.

  • Strong business knowledge in the Pharma/Biotech industry and associated processes is preferred. 

#LI-CGCM1

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10/18/19 Principal Systems Architect - Scientific Computing Individual contributor South San Francisco, California

Job Overview

The gRED IT Scientific Computing team is expanding and seeks talented and motivated High Performance Computing (HPC) engineers that wish to deliver the transformational scientific computing capabilities required to discover groundbreaking therapeutics. We are hiring at several levels including senior and principal engineer.

Applicants should have a learning mindset, be able to work in a fluid environment, and have a strong desire to pursue creative solutions to challenging problems.

This role will utilize and build on your experience in HPC application management and packaging, job schedulers, workflow performance tuning, parallel file systems, Linux computing environments, and DevOps/automation.

Who You Are
  • You have a Bachelor's degree or higher, perhaps in information systems, engineering, computer science, or another scientific field.

  • You have at least 3-5 years of experience with Linux computing environments, and strong system and storage administration skills.

  • You are comfortable with scripting and/or general purpose programming languages. We primarily use bash and Python.

  • You are comfortable working with software version control systems. We use git.

  • You are comfortable working across the full HPC software stack. Our technologies include EasyBuild, Lmod, Slurm, LSF, GPFS, NFS (Isilon), Grafana and Ganglia.

  • You have experience with, or interest in accelerator computing with Nvidia GPUs.

  • You have experience with, or interest in specialty application and development stacks including Python, R, and machine learning frameworks.

  • You have excellent interpersonal skills with your own team, technical IT partners, and customers

  • You are able to present your work, both verbally and in writing, to diverse audiences including customers, technical colleagues, and management.

  • You have experience and are comfortable performing many roles on a team including individual contributor, leader, analyst, or project manager.

  • You are comfortable working in a scientific environment, especially one that is related to drug development.

This position is based in South San Francisco and is not eligible for relocation.

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10/18/19 IT Business Partner Individual contributor South San Francisco, California

IT Business Partner

At Genentech/Roche, we believe every employee makes a difference. We are passionate about transforming patients’ lives. We are confident in both decision and action; we believe that good business means a better world.

As the Integrated Service Owner (ISO) you are a leader within the ERP North America Team, who is passionate about delivering solutions. We are looking for a highly organized and motivated individual who will support delivering digital strategy initiatives. Key focus areas include assessing various technologies, reviewing digital solutions, design, solution piloting and implementation. 

In this role, you will ensure the ERP team understands the desired experience of the customer and delivers the required services. You will ensure effective and appropriate mapping of business needs to technology capabilities.

As the Integrated Service Owner (ISO), Key responsibilities include, but are not limited to, the following: 

  • Conduct primary research into the emerging technologies and practices

  • Develop comprehensive understanding of emerging technologies and design forward-looking technology strategies

  • Work directly with clients to understand key business drivers, challenges and future growth opportunities. Develop clear requirement and solution proposals that clearly outline business challenges and goals. Influence technology selection based on best fit for purpose

  • Manage aspects of POC’s in Agile SDLC methodology 

  • Collaborate with solution architects and business analysts to identify and implement process improvements for solution delivery and support of new and existing solutions

  • Positioning GIS services in the ecosystem of complementary and competing external services

  • Participates in the Leadership Team of the North America ERP Team

Who you are 

  • We are looking for someone with a Bachelor's degree, Master’s degree preferred but not required

  • 10 + years of experience in a similar role

  • Solid technical background with understanding and/or hands-on experience preferred

  • SAP experience as an Architect, Principal Solution Designer or Analyst in multiple business process disciplines is key to this role 

  • Business Relationship management and partnering expertise

  • Experience evaluating and strong knowledge of today’s digital technology ecosystem and capabilities with a mind to enable business value and transformation

  • Experience with S/4 HANA, Cloud or Mobility

  • Demonstrated knowledge of blockchain technologies such as Hyperledger, Ethereum, Corda and key blockchain concepts such as smart contracts is highly desired

  • Expertise with IoT and Predictive Analytics is highly desired

  • Candidates should have software development experience 

  • An interest in learning new technologies and languages

  • Entrepreneurial spirit and passion to work within a fast-paced, rapidly changing environment

  • Experience with or driving production comparison evaluations via RFP’s is desired

  • Very strong verbal, written and presentation skills

  • Flexibility to travel for up to 20% (both domestic & internationally) 

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10/18/19 Advanced Analytics Product Specialist - Personalized HealthCare IT Platforms (PHC IX) Individual contributor South San Francisco, California

The power of data at scale has transformed almost every industry, personalizing experiences in many aspects of our lives. Yet in healthcare we’ve only scratched the surface. At Genentech and Roche we are accelerating the use of data insights and digital technologies to make significant strides to reach the full potential of personalized healthcare. We are seeking mission-driven, ardent, self-starting, creative individuals to join us in this effort.

The Advanced Analytics Product Specialist will work closely with key stakeholders in the PHC Center of Excellence and serve as trusted IT strategist to coordinate advanced analytics technology strategy with the PHC COE strategy and portfolio. The Advanced Analytics Product Specialist will be responsible for driving the design and implementation of the  IT strategic plan and work with stakeholders to identify technologies which enables the business to achieve its PHC vision and strategy. The goals is to design and implement the PHC Advanced Analytics Platform for Roche/Genentech’s current and future PHC needs.

The PHC Advanced Analytics Platform will provide data science users the capability to analyze large scale Global Scientific Datasets including Omics, Imaging, Digital and EHR modalities. The Advanced Analytics Product Specialist provides the business stakeholders a window to key innovative technology trends and evolution of technology within the healthcare industry, which has the potential to accelerate the fulfillment of the strategic vision. Through use of dashboards and governance boards, provides continuing communication to provide the business an overview of the progress of current IT innovation(s).

We expect the Advanced Analytics Product Specialist to be a passionate business and product advocate within IT, with proven analytical capabilities. The Advanced Analytics Product Specialist must be an effective negotiator, leader and communicator in working with Roche/Genentech’s multiple business units as well as with internal IT cross-functional teams. The ideal candidate will be a self-starter with a passion for transforming healthcare, a high level of flexibility, and commitment. The Advanced Analytics Product Specialist will join our diverse community of smart, fun, wholehearted, and engaged informatics professionals from various functional  areas. This person will share our community values of passion, courage, integrity, and gratitude -- all in-service of our mission, “doing now what patients need next.”

Responsibilities:

As Advanced Analytics Product Specialist on the PHC Pharma IX/Technology team, you will:

  • Partner closely with key stakeholders from PHC Center of Excellence, Research and Early Development teams (REDs), Product Development (PD) and Commercial business groups, and corresponding Pharma IT Groups and Global Infrastructure and Solutions (GIS)

  • Influence senior leaders across Roche and communicate PHC IX/Technology vision, strategy, goals, status, and impact

  • Develops the technology architecture, and detailed executable designs including critical investment plan in strategic technologies.

  • Conducts PoC in Advanced Analytics technologies e.g RStudio, Jupyter, Machine Learning tools e.g AWS Sagemaker and HPC’s etc.

  • Work with data scientists to apply machine learning algorithms to develop new models as well as enhance existing one

  • Ensures that the technology architecture and designs remain current with the business goals, and directs the development of architecture activities and projects, while aligning with current and long-term business and technology goals.

  • Promotes best practices to support scalability, skills transfer and organizational change management across the enterprise and architecture community.

  • Highlights short-term trade-offs vs long-term commitments and where those are worth implementing or not. Ensures that the Solutions are scalable (technology), efficient (process), effective (cost), and supportable

  • Mentor technical leads/software engineers to enable the individuals and the organization to develop a scalable and stable solution landscape

  • Have a broad knowledge and leverage the technical capabilities of the internal teams and external technology providers and vendors.

  • Conduct market assessments and to identify new capabilities for existing and future business needs.

  • Collaborate with other Architecture and Engineering groups across Roche

Qualifications:

  • Bachelor’s degree in Biology, Computer Science, Mathematics, Electrical Engineering, Information Systems or related field; Master/PHD in Business, Mathematics, Science, or Computer Science preferred

  • Overall 8-10+  years experience in Advanced Analytics Architecture and/or Engineering, of which at least 5 years as an Advanced Analytics Engineer or Product Specialist.

  • 3+ years of experience in leading design or implementation of Advanced Analytics and Data Science platform is required

  • Strong Hands on experience in designing and implementing Advanced Analytics Applications using multiple type of tools e.g. R, R Studio, Python, Deep Machine Learning Frameworks, TensorFlow, Keras, etc. is required.

  • Proven experience with Machine Learning tools, including one or more of: Numpy, SciPy, Pandas, Matplotlib, Jupyter Notebook, Spark.

  • Knowledge in Machine learning using Neural Networks, Statistical Models and NLP etc.

  • Define and develop technical requirements and design specifications for the core platform enhancements and analytics solution starters

  • Experience with reporting/visualization technologies e.g. R Shiny, AWS Quicksight, Tableau and Qlikview etc.

  • Strong hands-on experience with at least two of the public Cloud providers(AWS, GCP and Azure), different ML services and tools i.e. Sagemaker, AutoML and containers.

  • Strong awareness and market knowledge of Advanced Analytics & Data Science SaaS Services, platforms and tools e.g. datascience.com, h2o.ai, HPC landscape, container orchestration etc.

  • Handon experience in the Analysis of EMR/EHR, Omics, Imaging, Digital data modalities.

  • Ability to work in environment of competing and alternating priorities with constant focus on delivery

  • Excellent communication (written and oral) and presentation skills; solid business acumen; well-honed influencing skills are essential.

  • Self-motivated and team-oriented; able to work both autonomously and effectively as part of a geographically dispersed team

  • Ability to travel up to 25% time

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10/18/19 IT Business Partner - Digital Experience Individual contributor South San Francisco, California

The Role

The Digital Experience IT Business Partner (ITBP) will be reporting up to Workplace and Employee Experience Team Lead and be responsible for shaping up the new workplace technology at Genentech through information and technology partnering. The Workplace and Employee Experience Team is responsible to support Corporate Functions (Legal, HR, Site Services, Corp Relations etc.) at Genentech, deliver End User Technology (Devices, Software Deployment etc.) and provide a smooth employee experience via technology.

 

Responsibilities

As Principal ITBP in Digital Experience you will:

  • Partner with business stakeholders, co-create technology-enabled business strategies to enhance the digital experience

  • Lead roadmap development and technology strategy by influencing decision making and collaborating with GNE Corporate Functions (Site Services, HR, Corp Relations) and IT (GIS, PI & Group Functions)

  • Drive successful completion of strategic initiatives of high business impact by providing direction, aligning resources with shared business objectives

  • Analyze the current technology environment to detect critical deficiencies, recommend and implement solutions to create a holistic experience for corporate functions (e.g. visitor experience, registration, food service, managed meeting services, etc…)

  • Identify business opportunities and work with business and informatics partners to architect, design, prototype and deliver continually improved products

  • Work on complex business problems and provide highly innovative solutions using domain expertise, business intelligence to enable quality decision making

  • Negotiate and influence the success of key business initiatives by ensuring adequate allocation of cost and resources.

  • Take leadership role that educates, advises and challenges to enrich business area strategy for the benefit of the organization

  • Support Quarterly Business Reviews and be accountable for the Technology Portfolio

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

This position is based in South San Francisco, CA and is not eligible for relocation.

Qualifications/Experience:

  • Requires BA or BS and 12- 15 years of related experience. Preferred Master’s degree in technology with 6+ years of IT Business Partnership

  • Experience with the modern technologies and solutions: Cloud, Mobility, Analytics along with IoT’s in workplace

  • Has experience in implementing cross functional workplace technologies smart connected campus to improve digital experience

  • Demonstrates executive presence, strong business acumen, navigates ambiguity, manages complexity and can translate strategies and vision into executable plans

  • Exceptional knowledge of LEAN/KANBAN/SCRUM software development methodologies and understands market challenges and competitive issues

  • Keeps up to date with technology trends in workplace tech is able to quickly pilot technology for business value realization. Ensures execution accountability that maximizes the value realization

  • Understanding of advanced technical principles, theories, and concepts related to requirements, data, usability and process analysis

  • Exhibits an Agile mindset in the approach to work, i.e.:

    • Enables a diverse group of partners to speak with a single voice

    • Good enough instead of perfection

    • Focus on “Reuse before Buy before Make”

  • Exhibits a high degree of integrity, self-awareness, empathy, listening, active curiosity, awareness of different norms and expectations

#AfroTech19

10/18/19 Senior Desktop Support - Lab Systems Individual contributor South San Francisco, California

Sr. Desktop Support – Lab Systems

Job Summary:

Primary duties consist of the application of systems analysis techniques, including consulting with users to determine hardware, software or system functional specifications for client computing technologies. Provide security solutions using Microsoft Group Policy so computer systems are securely locked down as needed to ensure data integrity of lab computer data. Evaluates, maintains, modifies and documents client computing device changes and root cause analysis. Provides tier-3 technical support, guidance and expertise for projects and initiatives. Can independently make decisions that impact the project level and influence decision makers. Acts as team lead supervising other team members and able to represent manager in meetings making decisions relating to area of subject matter expertise.

Job Responsibilities:

  • Troubleshoot multiple computer platforms: Windows, Macintosh, Linux, and Mobility Devices.
  • Strong understanding of lab environments, GxP, system validation procedures.
  • Project Manager for global/local IT initiatives and project documentation.
  • Lead and deliver technical solutions for IT lab systems.
  • Coordinate with other site and corporate IT staff in the resolution of issues. Ensure that resolutions are consistent with IT standards and do not introduce additional conflicts.
  • Document resolutions, workarounds, and frequently asked questions for problems and service requests
  • Execute the delivery of services per Service Level Agreements to customers in support of a 24x7 mission critical environment.
  • Manage user accounts, access rights, device and print queues.
  • Support patching / security for all lab systems.
  • Maintain updated documentation on systems, such as hardware and software manuals, system site guides, change control, license agreements, and service contracts.
  • Communicates information, issues and potential solutions across project teams directly to customers.
  • Ability to work in a team environment or independently with minimal or no supervision.
  • Identify, develop and implement process improvement initiatives.
  • Ability to influence key decisions within areas of expertise.
  • Recognized as an expert in many specific technology areas.
  • Mentor and develop peers as needed.
  • Assist with new service pilots, deployments, and configurations.
  • Understands and adheres to incident management, request fulfillment, and knowledge management processes.
  • Ensures tickets are assigned and routed to the correct groups to ensure compliance with departmental Service Level Agreements (SLAs).
  • Identify trends for incident tickets that have breached.
  • Works with solution owner subject matter experts (SMEs) to document resolutions, workarounds, and FAQs within knowledge management solution articles.
  • Evaluate new technology and make recommendations as to possible departmental technology roadmaps.

Qualifications:

  • Working experience with creating and editing Microsoft PowerShell scripts as well as understanding of basic scripting concepts to administer and automate computer systems.
  • Deep knowledge and understanding of Microsoft Active Directory and Group Policy Editor with extensive understanding of how group policies work, ability to create and edit group policy to secure workstations.
  • BA degree in Computer Science or equivalent experience.
  • Minimum of 5 years of related experience.
  • In-depth knowledge of PC and Mac software and hardware for both desktop and laptop machines, in-depth knowledge of Microsoft Office suite of applications and Google suite.
  • Strong troubleshooting skills for issues that may impact networks, printers and other peripherals.
  • 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.
  • Strong organizational skills and ability to prioritize tasks among many competing requests.
  • Experience supporting mission-critical production systems in an enterprise environment.
  • 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 coordinates activities of others in a technical lead role.

#AfroTech19

10/18/19 Integrated Service Owner, GIS Integration Competence Center Individual contributor South San Francisco, California

Integrated Service Owner, GIS Integration Competence Center

Job Summary:

Do you want to be in charge of the strategy, experience and communication of your IT product or  service end-end for an innovative technology capability?

The teams in Global Infrastructure & Solutions (GIS) connect Innovation and Productivity, are ensuring we provide excellent support, while at the same time providing innovative IT solutions to all our customers who consume IT Services within Roche.

The Integrated Service Owner (ISO) is a leader with Product Management expertise who is passionate about building services that deliver excellent customer experience by considering “What would a customer say?” both in our approach to Services and in measuring what matters to them.

Key Responsibilities:

Identify and Assess Opportunities: 

  • Ensure the GIS organization understands the desired experience and delivers the required consumer experience for the services.
  • Ensures effective and appropriate mapping of business needs to technology capabilities.

Define your Service:

  • Aligns strategic direction with key stakeholders.
  • Defines Integrated Service Strategy & Roadmap, influences product Standards and Lifecycle plans, and proposes projects to create or enhance the service.

Evolve your Service:

  • Manages consumer experience and satisfaction with the integrated service while appropriate focusing on cost efficiency. 
  • Defines service marketing/communications to consumers to drive appropriate use of the service.
  • Tracks service utilization and cost to ensure GIS is doing the most with our resources.
  • Ensures meaningful qualitative & quantitative KPIs are in place and are managed.
  • Seeks opportunities for continuous improvement across all components that comprise the service.
  • Positions GIS services in the ecosystem of complementary and competing external services .
  • Create and maintain trust and mutual understanding

Qualifications/Requirements:

  • Bachelor’s Degree with 12+ year’s experience, Master’s degree preferred
  • Solid technical background with understanding and/or hands-on experience preferred
  • Demonstrated excellence in product/service management and customer relationship/account management.
  • Solid understanding of Integration Services, delivery framework and middleware capabilities (traditional ESB products and iPaaS)
  • Proven track record of managing all aspects of a successful product/service throughout its lifecycle
  • Proven ability to develop product/service and marketing strategies and effectively communicate recommendations to executive management and consumers at all levels.
  • Skilled at working effectively within cross-functional teams in a matrix organization
  • Excellent written and verbal communication and presentation skills
  • Product Management, Understanding the Customer, Product Development, Requirements Analysis, Pricing, Planning, Competitive Analysis, Financial Planning and Strategy development.

#LI-CGDL1

#AfroTech19

10/18/19 Sr. Linux System Administrator (HPC/Dev Ops) Individual contributor South San Francisco, California

Sr. Linux System Administrator (HPC/DevOps)

As part of the Global Operations team we are looking for an infrastructure engineer based in South San Francisco for our High Performance Computing (HPC) environment. You will manage agile computing environments in several locations to support our Research Partners on supporting the relevant infrastructure components to achieve agility and performance. This includes installing, configuring, administering, and fine-tuning our High Performance Computing environment and related infrastructure components across the organization in a timely, cost-effective and efficient manner.

Responsibilities:

  • Assist on the design of the new HPC infrastructure and evolution of the current environments.

  • Ensures installation, configuration and operation of the environments to achieve the performance and agility of the various applications supported (in the range of several hundreds).

  • Contributes to the concept, planning and execution of projects.

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Qualifications:

  • Bachelor’s degree in Computer Science or equivalent work experience

  • Must have Linux Administration and scripting experience (other programming language a plus) and HPC

  • Senior level technical operational skills, such as troubleshooting, capacity planning, and root cause analysis

  • 7+ years of Linux System Administration and work related experience

  • 3 + years of experience and knowledge of HPC

  • DevOps experience a plus (Puppet, Jenkins)

  • Excellent customer orientation and delivery focus with good end user perspective

  • GPFS basics

  • Configuration management (GIT/Stash, Puppet, and basic Bright knowledge)

  • Experience working in a fast changing environments where solutions are deployed and retired at high pace

  • Demonstrated problem solving skills

  • Good communication and interpersonal skills

  • Ability to work effectively alone or within a team, including virtual teams

  • Proactivity, with a clear ability to think beyond boundaries, take controlled risks and assume responsibilities

  • Understanding of Computer Systems Validation and ITIL concepts, preferred

  • Active open source contributor

  • Working experience in pharmaceutical or scientific/research sector is a plus

  • Experience working in a global organization, working in an international and multicultural environment considered a plus

Basic knowledge in:

  • High Performance Computing (HPC)

  • Dockers: Mesos/Marathon, DC-OS

  • Monitoring: Ganglia, Grafana, ELK, Influxdb

  • Provisioning: Katello/ Foreman, Jenkins

  • Network: Mellanox

Advanced knowledge/consideration:

  • More than 5 years of HPC experience (High Performance Computing)

  • Monitoring: Ganglia, Grafana, ELK, Influxdb

  • Provisioning: Katello/ Foreman, Jenkins:

  • Network: Mellanox

  • Dockers: Mesos/Marathon, DC-OS

#AfroTech19

Important Information

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity protections, view the EEO is the poster.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at [email protected].

Genentech will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.