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Date Job Title Job Level Location
3/28/17 Sr. Manager - Policy, Access and Coverage Trends - Market Analysis and Strategy Manager South San Francisco, California
  • Works on consumer / patient-related healthcare policy and trends affecting individual, employer and emerging purchasers of health care including macro issues that affect patient access to health care, benefit coverage, and purchasing decisions.
    • Affordable Care Act, patient cost burden, public Marketplaces, private exchanges, quality, cost transparency, decision support tools, benefit design, narrow networks, etc.
  • Partners with many functions throughout the organization (Government Affairs, Managed Care Marketing, Medical Affairs, Market Analysis & Strategy, etc.) and leads cross-functional teams to:
    • Understand and assess impact of patient issues
    • Outline implications for Genentech’s business, including access to and reimbursement of our products
    • Develop recommendations for go-forward, including how we interact / navigate with patients/purchasers of health care; this role is critical to informing insights for strategy development, but is not responsible for Genentech patient strategy or execution
  • Facilitates structured problem solving to answer key questions and manages project resources to successful outcomes (on time, on budget, within scope)
  • Develops and leads primary research, secondary data analytics, and modeling studies
  • Quantifies financial impact of issues (where relevant) to Genentech’s business, including patient, volume and revenue forecasting
  • Synthesizes data into actionable insights, strategies, and tactics, and creates findings reports / presentations
  • Presents findings and recommendations to Senior Leadership, including CEO and his direct reports
  • May have direct report/s so the ability to direct team members and guide work and performance would be a plus
 ...
3/28/17 Senior Operations Specialist, Packaging Experienced Hillsboro, Oregon

Please note there are two positions available; both are Monday through Friday.  Positions could be either Day or Swing shift. 


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

 

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

  • Passion and drive to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customers.
  • Embraces Class A principles and behaviors.
  • Continuously in search of ways to maintain the highest levels of productivity.
  • Actively participates in a teamwork environment that maintains a high performance culture.
  • Continuous Improvement mindset with an ability to directly impact increased equipment reliability/uptime and product or component yields
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3/28/17 National Managed Care Liaison Experienced South San Francisco, California

The Managed Care Liaison (MCL) is a member of a field-based team assigned to develop and cultivate relationships with key decision-makers and other influencers in managed care organizations, government programs, employers, hospital systems and product distribution companies, to enhance access to and optimize formulary positioning for Genentech products. A key aspect of the MCL’s responsibilities is to keep payers and other key external constituents or influencers abreast of new product launches, line extensions and Medical Affairs research. 


 

Responsibilities: 

 

This position will report into the National MCL Account Associate Director.

 

Provide portfolio clinical product support to managed care account teams focused on Cigna, Employers and related accounts.

 

Provide medical expertise internally and externally to support optimized access and product pull-through on segment initiatives (employers, pharmacy benefits management organizations)

 

Provide account relationship support to managed care account teams by identifying and developing relationships with key decision-makers in managed care organizations and other institutions that purchase, influence or manage the use of Genentech products.

 

Contribute managed care business, health plan and clinical input to help shape product strategies for optimized access and formulary positioning for Genentech products.

 

Provide field support to generate applied science research demonstrating the value of Genentech products in real-world clinical use.

 

Provide USMA medical teams with the managed care perspective for strategic plans and tactics to translate of clinical science into clinical practice.

 

Assist in the development and implementation specific programs, tools and other resources to support Genentech’s value-based approach to medicine. 

 

Act as a conduit between the external payer environment and the HEOR in-house HEOR and managed care medical communications teams ensuring strategies and tactics are robust in filling key performance and evidence gaps from a payer perspective.

 

Provide scientific information and education to external customers, decision-makers and other influencers in response to unsolicited requests. 

 

 

Attend and represent Genentech through advisory panels, advisory boards and other professional and/or policy-making forums to influence the healthcare debate and advance Genentech’s mission to be the leading biotechnology company in the U.S.

 

Comply with all laws, regulations and policies that govern the conduct of Genentech activities. 


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3/28/17 Assoc Director, Operational Excellence- Vacaville, Ca Executive (Director/VP/SVP) Vacaville, California
Oversees the development and implementation of Operational Excellence for the Vacaville site activities. Coordinate activities related to the implementation and dissemination of the Global Operational Excellence Program. Champion Lean Production System (LPS) and maturing the site's Lean capability to improve site performance and deliver site/PT strategy.    Leadership & People Management:
  •  Creates an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.  Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
  • Establish strategic goals and objectives and maintain full strategic responsibility for the organization.
  • As a site leadership team member, drive collaboration within site and across network activities, cross-functional planning, and decision making.
  • Accountable for overall budget and financial performance of the Operational Excellence Support organization.
  • Proactively promote positive Safety Culture and cGMP operating principles.
  • Embody PT lean leadership principles and methods while fostering a continuous improvement mindset
   Technical:
  •  Focuses on building and applying continuous improvement methodologies
  • Ensures body of knowledge is current and industry leading for continuous improvement methodologies
  • Provides leadership for continuous improvement:
    • Labor
    • Equipment
    • Process
    • Yields
    • Materials/Component
    • Cost reduction
  • Oversees training in Lean and Six Sigma concepts and methodologies, coach and develop capabilities for Lean and LPS
  • Oversees improvement teams through “Kaizen” style continuous improvement tools  
  • Facilitates dialogues between leaders of Operational Excellence projects and sponsors
  • Supports all areas of site operations in identification and problem solving solutions
  • Manage the Operational Excellence team (OE Practitioners)
  • Ensures site has installed and is effectively practicing defined business processes and Lean Production System
  • Responsible for effectively applying Global LPS standards where appropriate to improve site performance and deliver site and global strategy
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3/28/17 Technical Development Associate Scientist - Analytical Dev/ Quality Control Experienced South San Francisco, California

The job responsibility within the Biological Technologies group in Analytical Development and Quality Control, is to develop, validate, and troubleshoot biochemical/immunochemical and cellbased assays for clinical products.

  • The successful candidate will perform testing in support of process development, stability, and lot release according to established test procedures and in compliance with cGMP’s.
  • Expectations may also include routine lab maintenance, writing S.O.P.’s, test procedures, protocols, reports, summarizing/presenting data and participating in inspection by regulatory agencies.
  • Additional responsibilities may include writing data analysis template for new assays, equipment qualification, and supporting collaborations with other groups/sites.
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3/28/17 Intern - Product Development - Business Process Associate Entry Level South San Francisco, California
GENERAL DESCRIPTION  The business process associate Intern assists with the execution of strategic business process reengineering efforts under the direction of Business Process Leads in the Development Process Office within the Product Development organization at Genentech; we are looking for someone with a hybrid Consultancy, Analyst background. Comfort in ordering various competing priorities & organizing process, technology & people. Background & exposure to Business Process (Six Sigma, Lean, implementation focused project manager) is desired; someone who is familiar with process improvement methodologies but has had exposure to implementing it in real world conditions. 
The associate will document processes, learn & apply the DPO’s process mapping approach, analyze various data sets & produce compelling & concise reports for review & assist the team in various projects.
Comfort applying, adapting & implementing LEAN & other Process Tools in a non-manufacturing setting.
ESSENTIAL DUTIES AND RESPONSIBILITIES 
  • Will work with the Business Process team on documenting and creating repeatable, sustainable, and scalable business processes.  
    • Partner with the DPO team in working with various stakeholders across End to End Processes to assess the current state through document reviews/summaries, consultative reports, conduct analysis, capture requirements end-to- end with an eye towards simplifying and globalizing processes.
  • Assist in implementing process improvements which will drive business results  
    • Work with team in simplifying internal business processes through a standardized approach
    • Assist with identifying and documenting current state (as-is) process, system, and data flows through process mapping, value stream mapping & other process methods
    • Participate in design and documenting future state (to-be) process, system, and data flows
    • Assist in the organizing and facilitation-support of various company wide forums, seminars & larger scale process oriented conferences; goal is to build & grow a Community of Practice
    • Assist in analyzing, synthesizing & reforming Standard Operating Procedures
    • Assist in developing, analyzing, updating & reporting the organization’s dashboard(s), KPIs & other metrics
    • Assist in developing, analyzing, updating the DPO’s Program/Project plans through a milestone/GANTT approach
    • Other similar activities as assigned
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3/28/17 QC Scientist / Sr QC Scientist, PAC-Validation (E4/E5) Experienced South San Francisco, California

The QC Scientist/ Sr. QC Scientist will be a member of the Protein Analytical Chemistry Validation & Testing Department (PAC-VT). PAC-VT is one of the five departments that comprise Analytical Development and Quality Control (ADQC) organization within PTDU.

 

PAC-VT team is responsible for performing GMP and GLP release and stability testing of preclinical and clinical products for protein therapeutics, antibody-drug conjugates, and supporting functional testing of combination products. PAC-VT is responsible for the validation life cycle of quality control methods until established as part of a commercial control system.

 

The candidate should have in-depth scientific knowledge and experience in the development and validation of analytical methods, covering a wide array of analytical techniques such as HPLC, CE, MS, and wet-chemistry. He or she will be involved to ensure the proper and timely execution of all aspects of the life cycle clinical analytical methods across Genentech's clinical product portfolio and testing sites (including CMOs and partners).

 

The individual is expected to author, review or approve Quality documents in development phases such as method validation protocols and reports; stability protocols and reports; method validation master plan and reports; Author sections in regulatory submissions (INDs, BLAs, etc.) and support Q&A from health authorities.

 

The individual is also expected to lead or participate in cross-functional Analytical tech transfer team, which is responsible for overall planning, coordination, communication of analytical deliverables for a product launch (including method co-validation with the commercial QC sites;  transfer of In-Process, Release and Stability test methods from PTD to commercial QC sites; transfer of product quality knowledge to Commercial such as control system specifications, IMP stability, Reference Standard, Change Control, etc.)

 

Additionally, the candidate is expected to be a key player in Genentech's business process for continuous innovation and improvement. The position involves a multitude of interactions within a global matrix organization, excellent communication and presentation skills are essential.


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3/28/17 Clinical Safety Assoc I Experienced South San Francisco, California

The Clinical Safety Associate I (CSA I) supports the drug safety staff in the day to day operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information

received by US Drug Safety. The CSA I supports study management activities in collaboration with other functional groups and supports the US Drug Safety Case Management Manager (CMM) in all activities. All responsibilities are performed under the direction of the CMM.


Key Accountabilities:


Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and Genentech/Roche Standard Operating Procedures

(SOPs) (~60% and as per business needs)


Reviews, evaluates and verifies potential AE information to determine required action per internal policies and procedures


Provides medical assessment on all cases for seriousness / validity / causality and conducts quality review of all cases (as applicable) including medical review of information entered in the safety database for completeness and coherency


Performs follow up (e.g. Drug specific questionnaires / Pregnancy reports etc.) for all reported cases (as applicable) based on their assessment (i.e. Medically significant, non-serious, invalid etc.) to capture complete medical picture of an ICSR


Medically reviews ancillary documentation accompanying Individual Case Safety Reports (ICSRs) and identifies medically relevant safety information for incorporation into the Global Safety Database


Demonstrates understanding of appropriate labeling documents for Genentech/ Roche molecules and products and performs labelling assessment for AE(s) received using clinical knowledge


Identifies and collaborate with external stakeholders for Antibody testing requests


● Responsible for identifying ICSRs requiring expedited safety reporting to Health Authorities. (~5%)


● Responsible for review and implementation of internal Manuals, global / local safety SOPs / Work Instructions (applicable to USDS). Identify the need for creating additional or updating existing local Guidance Documents including but not limited to training matrix and identify appropriate target audience for training assignment. (~3%)


● Demonstrates a general understanding of protocol management in accordance with PV related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) to support the protocol review process for supported/funded studies (~10%)


Perform Post Authorization Safety Assessment (PASS) classification for all Genentech /Roche supported studies based on medical knowledge and European Union (EU) regulations


Assists in reviewing Safety Data Exchange Agreements (as applicable)


Participates and supports the Supported Research Team (as applicable)


Assists in AE reconciliation and/or Case Transmission Verification (CTV) activities (as applicable)


Acts as single point of contact for safety related issues


Acts as Safety Liaison between Safety Science and Supported Research Team


Oversees Safety related activities for assigned Genentech/ Roche Product(s) managed by US Medical Proprietary – For Genentech Internal Use Only Version: 2017 Affairs to include (~10%)


Demonstrates advanced knowledge of the safety profile to include comprehensive working knowledge of appropriate labeling documents for assigned Genentech/ Roche Product(s)


Communicates and updates Team of any process related issues/ concerns


Acts as single point of contact for safety related concerns


Acts as Safety Liaison between Safety Science, Supported Research Teams (SRT) and Medical Team


Responsible for medical review and updating of safety sections for documents e.g. pregnancy letters and notify appropriate stakeholders of any changes in executive summary of aggregate reports


Assist in implementation of Risk Management Plans (RMP) / Risk Minimization activities or Risk Evaluation and Mitigation Strategies (REMS) for assigned molecules / products


● Assists in projects under the direction of US Drug Safety management or project lead (~10%)


● Contribute to the preparation and development of Drug Safety presentations for internal/external stakeholders as applicable (~2%)


● Liaise with Compliance and Training (CAT) / Business Operations Analytics and Market Research and Patient Support (BAM) teams within USDS to ensure all processes are implemented

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3/28/17 Associate Director - Business Support- Vacaville, Ca Executive (Director/VP/SVP) Vacaville, California
Vacaville Business Support position will direct, manage and oversee the processes and projects at the site to ensure successful delivery of its mission, goals and strategy.  This includes IT, Portfolio, Project Management, Risk Management, site business planning, training, and site-wide communications functions.  Business Support ensures a training and learning environment which enables the employees and the organization to build the skills and capabilities needed to deliver on their tasks. Leadership & People Management:
  • Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.  Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
  • Establish strategic goals and objectives and maintain full strategic responsibility for the organization.
  • As a site leadership team member, drive collaboration within site and across network activities, cross-functional planning, and decision making.
  • Accountable for overall budget and financial performance of the Business Support organization.
  • Proactively promote positive Safety Culture and cGMP operating principles.
  • Embody PT lean leadership principles and methods while fostering a continuous improvement mindset 
  Technical:
  • Responsible for developing the  Site Business Plan and Operational Plan
  • Develop and oversee the site-wide Communications strategy and execution
  • Support development, implementation and monitoring of Site Goals and KPI’s
  • Responsible for implementation and continuous improvement of business processes at the site
  • Ensures site alignment with PT goals, systems and business processes
  • Directs and develops site Program Management Office (PMO) processes and ensures alignment of the site and network portfolios
  • Oversee product technical transfers execution (XTL’s)
  • Provides oversight and ownership for the site Risk Management Process including Quality, Safety and Business Risk
  • Provides oversight and ownership for the site Business Continuity
  • Oversees the investment and project execution of Capital projects in partnership with global engineering PTA
  • Lead and develop Technical Training for site, including adult learning theory, training administration/logistics, training program management, new hire and contractor onboarding, and overall accountability for training at the site. 
  • Ensures a compliant training environment and documentation system
  • Oversee and implement Business Process Management, Operations reviews, Resource Management, and Governance for site
  • Drive Business Process Management excellence
  • Local dotted line leader for IT support at the Vacaville site
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3/28/17 Sr./Principal Business Manager - Development Sciences, Business Management and Communications Experienced South San Francisco, California
The Business Management and Communications group’s vision is to provide the most efficient and strategic business solutions for Development Sciences (DevSci). 

The Sr./Principal Business Manager will contribute to the success of DevSci by leading strategic planning activities and providing business management support to key scientific functions, managing essential cross-functional projects, as well as taking ongoing responsibility for certain key business processes. 

The Business Management group ensures effective management of a wide range of projects and processes, for ~500 scientists and managers, in such areas as:
  • Partnering with functional area heads (VP/Director-level) to enable them to meet functional goals and improve operational capabilities
  • Being a thought-partner and advisor to DevSci leaders on business, organizational, and operational strategies and solutions
  • Planning and implementing functional and cross-functional initiatives and deliverables
  • Leading or managing DevSci initiative teams to ensure that deliverables are achieved timely and with a standard of excellence
  • Identifying and potentially leading cross-functional business process improvement projects
  • Representing DevSci by liaising with other Genentech Research & Early Development (gRED) and corporate functions
  • Owning and/or support various DevSci programs that contribute to Great Place to Work and innovation
The Sr. / Principal Business Manager will be involved in multiple teams and support one or more functions simultaneously, as well as contributing as an individual on less complex efforts.

Successful factors for the Sr./Principal Business Manager include:
  • Partnering with scientific functional leaders in driving business initiatives within the functions
  • Balancing the needs of multiple competing priorities, with internal customers from several departments
  • Providing project management expertise to cross-functional teams, including goal setting, planning, facilitation, conflict resolution and team building
  • Independently managing and influencing multiple stakeholders simultaneously in a matrix organization
  • Facilitating resolution of issues relating to projects, priorities and team dynamics
  • Demonstrating creativity, independence, and initiative in resolving issues
  • Understanding the strategic, big picture priorities while managing the detailed execution of deliverables
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3/27/17 Sr. Scientific Researcher, NMR Spectroscopy - Structural Biology Experienced South San Francisco, California
We have an opportunity for a talented NMR spectroscopist to join the NMR group in the Structural Biology Department, to explore the structure and function of proteins of therapeutic interest. The successful candidate will be responsible for applying NMR-based strategies to support small molecule and large molecule drug discovery programs. Day-to-day activities and responsibilities include protein sample purification and handling, protein characterization, hands-on NMR data acquisition and analysis to assess ligand/protein interactions, as well as protein-protein interactions involved in regulating biological pathways. Our protein NMR facility includes dedicated 800, 600 and 500 MHz spectrometers, Linux workstations and access to the Central California 900 MHz spectrometer.
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3/27/17 Therapeutic Area Lead Experienced South San Francisco, California
Relocation has been designated for this position.
The Position
Therapeutic Area Leader - Product Development (PDG) Oncology

The Therapeutic Area Leader (TAL) provides leadership to develop & deliver global strategies for implementation and execution of Roche’s Oncology portfolio.

The TAL provides strategic input into the Roche oncology portfolio and manages a team of senior Operational Program Leaders to deliver on projects in line with PDG operational plans and overarching PD strategy.

As a member of the Oncology Operational Leadership Team (OOLT), TALs contribute to defining and implementing PDG’s Oncology vision, priorities, and strategy. The TALs partners with a broad set of senior stakeholders across the franchises and global functions to enable smart development & delivery of the oncology PD portfolio.

The Therapeutic Area Leader position:
  • Leads development of Disease Area Operational Strategy by:
    • Designing strategic frameworks to inform operational delivery of the portfolio 
    • Enhancing cross functional collaborations and practices to support efficient execution on the oncology operational strategy
    • Developing a long term Disease Area Operational strategy to support future operations of oncology clinical trials 
    • Leading a Disease Operational Team (DOT)
    • Providing functional management to the Program Leadership Group (Operational Program Leaders)
This position reports to the Global Head of PDG Oncology and is Basel, Welwyn, or South San Francisco-based

Major Responsibilities and Accountabilities
  • Contributes functional expertise to the development of the operational strategy and participates actively at Development Review Committees (DRCs) as the PDG reviewer.
  • Accountable for the delivery of programs and studies in respective oncology Disease Areas (DA). 
  • Anticipates new trends in competitive or disease area landscape to guide the organizational strategy accordingly. 
  • Recognizes opportunities to create value for Roche Oncology and proactively lead efforts to maximize PDG’s competitive advantage through such efforts. 
  • Assesses different operating models to incorporate new and novel approaches to planning and execution of clinical programs
  • Applies strong analytical skills to translate data to strategies and action plans. 
  • Effectively collaborates across the 4 oncology DAs to ensure consistency and best practices are implemented.
  • As a member of the OOLT:
    • Contributes to defining and implementing the strategic direction, objectives and goals for the Oncology TA as well as the DAs.
    • Provides a consolidated overview of programs within their DA including the strategy, status and project issues.
    • Works with other leaders to remove barriers at the program level.
    • Contributes actively to making the Oncology Operations Leadership Team into a highly functioning team.
  • Proactively works cross functionally to ensure Program Leadership resources are efficient and effective:
    • Actively participates in appropriate governance at the cross Therapeutic Area level.
    • Collaborates effectively with leaders and staff within and outside PDG to ensure PDG Oncology is meeting its business objectives. 
  • Provides leadership, coaching, and line management to global staff in the assigned DA.
    • Provides strategic guidance to the OPLs personnel on their programs to ensure they are contributing at a high level of excellence on their teams.
    • Ensures the performance of employees is proactively managed and they are coached, trained and developed in order to maximize their contribution.

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3/27/17 Operations Manager - Commercial Business Practices Group Experienced South San Francisco, California
The Function:

Business Practices Group (BPG) is a functional group within Commercial Business Operations (CBO) comprised of experienced specialists who partner with the business to deliver industry-leading compliance and operations functions. Business Practices Group (BPG) Operations sub-department provides strategic planning, communications and operational leadership for the Business Practices Group department.

The Position:

The BPG Operations Manager will support planning, operations and communications for the BPG organization (a functional unit of approximately 90+ employees). You will support other BPG Planning, Operations & Communications team members with a variety of activities, which may include strategic and tactical planning, budget development and tracking, space and capacity planning, planning and execution of meetings, business processes, communications, employee engagement and other relevant initiatives.

Incumbents in the Operations role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of Genentech activities.

Key Activities:
  • Helping maintain best-in-class business processes, systems and other tools that optimize effectiveness and efficiencies across BPG, including business planning processes, templates, broad BPG communication practices and other tools 
  • Helping track, monitor and report the key performance indicators of BPG’s business strategies, plans, budgets, capacity, other resources and business metrics
  • Responsible for identifying, recommending and implementing best practices across all relevant BPG operations and other activities. Proactively identifies potential synergies and/or redundancies to optimize operations and resources across BPG.
  • Actively contributes to the BPG teams to lead, coordinate and / or implement initiatives supporting BPG by contributing to best practices and continuous improvement within the Operations community
  • Manages special projects, as assigned. Includes developing detailed project plans, managing project teams, managing development and implementation of project deliverables, supporting project implementation with change and communication plans and keep all internal customers, partners or other stakeholders abreast of project milestones, risks, challenges and results
  • Ensuring assigned goals and objectives are met or exceeded and that assigned projects and other work are completed on time, to high standards and within budget 
  • Supporting cross-departmental communication of BPG’s mission, objectives, strategies and progress. Working collaboratively with all internal and external customers, partners and other stakeholders.
  • Where applicable, supporting the content development, coordination, agendas and other materials for key meetings across BPG
  • Managing the coordination, development of communications and activities to drive employee engagement such as: All Hands meetings and the BPG Offsite
  • Maintains awareness of applicable regulations, policies and guidelines necessary to perform role
  • Acts in complete & total compliance with all laws, regulations and policies 
Critical Competencies:
  • Strategic agility – Links responsibilities with the mission of the organization; focuses on activities that add the most value
  • Communication – Listens well; expresses ideas fluently and logically; is open to input and can be depended on for truthfulness
  • Teamwork and collaboration – Creates an atmosphere of openness and trust; collaborates; offers support and encouragement
  • Achieving results – Is goal directed and persistent; is accountable for meeting commitments; recognizes the contributions of peers
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3/27/17 Sr Operational Specialist, Inspection (Day) Experienced Hillsboro, Oregon

Main Purpose of the Position:

Under the directionof Manufacturing or Packaging Supervisor or other qualified OperationsSpecialist, perform a wide variety of tasks and operations that are required toformulate, fill, and package sterile pharmaceutical products in a state-of-the-art,automated production and packaging facility. Troubleshoot, maintain, assemble,install, and repair all electronic, mechanical, and instrumentation devices onproduction equipment as required. Assist on major equipment overhauls, repairs,and installations as necessary. All operations will be carried out incompliance with cGMPs, Standard Operating Procedures (SOPs), product recipes,and Genentech standards.

 

Inaddition to performing the responsibilities/tasks below, the successful candidatewill need to demonstrate the following traits:

 

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

 

 

Responsibilities:

  • Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
  • Perform safety and housekeeping audits as required.
  • Set up, change over, and test run equipment for various-sized vials and packages as required.
  • Make mechanical and electrical adjustments necessary for the correct operation of the equipment.
  • Act as a troubleshooter, moving between all areas to assist related crafts in the performance of their duties. Diagnose problems involving electronic, electrical, instrumentation, and pneumatic hydraulic control systems. Work with the maintenance department and/or outside services to repair, maintain, and calibrate these systems as required.
  • Perform or coordinate major and minor overhauls of production equipment as needed.
  • Perform training of other Operations Specialists.
  • Assist in the development of plant SOP's and training materials.
  • Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
  • Assist and/or operate all sterile filling and final vial packaging equipment in the plant.  Perform material handling in the plant as required.
  • Perform preparation of sterile components.
  • Assist in the cleaning, set-up, sterilization, and performance of maintenance on a variety of processing equipment.
  • Perform bulk thaw, dilution, and formulation operations.
  • Conduct environmental monitoring activities in the manufacturing areas as required.
  • Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
  • At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs, process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency.
  • Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
  • Perform cleaning and housekeeping duties as required.

 

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3/27/17 Associate Program Director/Program Director, Regulatory CMC Biologics Marketed Products Experienced South San Francisco, California

Locations:  The position may be located in South San Francisco, CA , Vacaville, CA, Oceanside, CA or Hillsboro, OR

 

In the position of Associate Regulatory Program Director or Regulatory Program Director in Pharma Technical Regulatory (Technical Regulatory Leader), you will be accountable for the preparation of CMC regulatory submissions and strategies supporting the product’s lifecycle and business needs.

 This Technical Regulatory Leader role is focused on the development of strategies supporting biologic marketed products. Demonstrated leadership capabilities, a proven ability to work cross-functionally, and recognized strengths in collaboration, teamwork, and communication is a requirement for this role.

You will be tasked to navigate and lead the preparation of complex global regulatory strategies with support from global team members representing both technical regulatory and various cross-functional representatives.

 

You will be responsible for timely compilation of all necessary CMC documentation to support technical content of regulatory submissions. You will ensure quality, content and format of regulatory submissions comply with applicable regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics. With a focus on biologics marketed products, you will also be required to provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management.

 

Additionally, you will support departmental business processes to document and improve best practices and work efficiencies.

 

The Technical Regulatory Lead must maintain a high level of professionalism, efficiency, and follow-through as the primary regulatory liaison for the assigned product.

 

The successful candidate will demonstrate effective problem solving, strong understanding of regulatory, excellent interpersonal/collaboration skills, the ability to prioritize multiple tasks and lead in a matrix team environment.

 

Must have a proven ability to communicate effectively in both a written and verbal format. Have a demonstrated ability to work both independently or collaboratively in a team structure, including a proven ability to work well under pressure.

 

The incumbent will be skilled to lead communications with FDA and other regulatory agencies to facilitate review and approval of submissions.

 

 

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3/27/17 Senior Scientific Researcher - Oncology Biomarker Development Experienced South San Francisco, California
The Department of Oncology Biomarker Development at Genentech Research is seeking a highly motivated Senior Scientific Researcher to contribute to the development of predictive/pharmacodynamic biomarkers in support of Genentech's extensive Early Development oncology portfolio. The successful candidate will work closely with an interdisciplinary team, including colleagues from research, bioinformatics and clinical sciences.

Responsibilities
You will be responsible for translational research to enable the development of
biomarkers and assays for use in the clinical development of cancer vaccines.
Experimental strategies will include application of cellular immunology in developing immune monitoring assays. Specific responsibilities will include processing and analyzing clinical trial samples, data analysis and presentation, and contributing to experimental design and planning.

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3/27/17 Clinical Biomarker Operations Manger Experienced South San Francisco, California
Position Purpose:
  • Provides biomarker operational expertise and guidance to multiple cross-functional global Protocol Execution Teams (PETs), to implement scientifically driven clinical development plans. Single point of contact on Biomarker Sub Team (BMST), Companion Diagnostic Joint Project team (CDx JPT), Clinical Sub Team (CST), PET and with CRO partners on all aspects of biomarker operations 
  • Ensures the timely and efficient delivery of all biomarker operational aspects of gRED clinical studies, including company collaboration and academic collaboration studies across all stages (start-up, conduct and close-out), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.
Main Responsibilities and Accountabilities:
  • Provides biomarker operational expertise and guidance to global Protocol Execution Teams (PETs)
  • Accountable for executing exploratory and companion diagnostic biomarker strategy, including planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (collection, processing, analysis, data delivery process and final sample disposition). 
  • Authors biomarker portions of key clinical documents including Clinical Study Protocols, Informed Consents and Laboratory Reference Manuals. 
  • Develops and maintains effective working relationships with team members, with particular focus on the BMST, operational team, diagnostic partners (Roche DIA), external CRO and Central Lab (for outsourced teams), and external biomarker vendors, where applicable. Close collaboration with Biomarker Scientists, CDx Project Leaders and Clinical Trial Leaders. Core, standing member of multiple teams.
  • Builds and maintains effective and efficient high performing biomarker sample analysis & data delivery. Supports relevant stakeholders including Clinical Data Management, Biometrics, Biostatistics in their accountabilities, responsibilities and deliverables, including data analysis for go/no go decision making, filing of the clinical study report (CSR). Manage data delivery timelines in accordance with internal decision making/governance meetings (OBRF, DxRF, DRC, etc).
  • Responsible for the identification, validation and selection of biomarker vendors in collaboration with the Biomarker Scientist and GPPS; ensuring appropriate cross-functional input is incorporated into the scope of work. Partner with Biomarker Scientist for biomarker assay development at vendors, leading operations of assay development and ensuring assay readiness in accordance with clinical sample testing timelines. 
  • Liaise with internal CDx function and external CDx partners to facilitate companion diagnostic development as needed and serve as a member of the CDx Joint Project Team
  • Ensure collection, delivery and analysis of biosamples under the highest standards of quality, ethics, and informed consent at study level 
  • Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans
    • Ensures biomarker operational tracking and project management tools are utilized to meet the needs of the operations team
    • Supports the development of the biomarker analysis budget and manages it on a study level. Communicates variances in the budget as appropriate.
    • Establishes biomarker sample analysis and data delivery milestones and ensures accurate tracking and reporting of Biomarker sample metrics. 
    • Provides study level updates to stakeholders, clinical study teams and biomarker teams including sample collection, assay status and analysis updates
  • Provides clinical biomarker operations expertise to ensure operational feasibility and delivery
    • Responsible for assessing feasibility for biomarker operations plans on clinical studies across related functions
    • Leads the development and finalization of the Biomarker Management Plan (BMP) based on input from scientific and operational stakeholders to execute biomarker operational strategies
    • Reviews and provides recommendations into all study related documentation (including protocol, informed consent form, and amendments) and processes.
    • Participates in Investigator and Pathologist meetings, monitor training, CRO kick-off meetings, as applicable, to deliver presentations and in-depth trainings to internal and external stakeholders on biomarker and companion diagnostic sample collection and handling procedures
    • Contributes to HA exchanges specifically by providing responses to biomarker sample related questions or issues from Health Authorities or Ethics Committees.
    • Co-develops protocol feasibility questionnaires to ensure sites can meet sample-handling needs for the study 
    • Provides input into the development of PET goals.
  • Delivers the ...
3/27/17 Postdoctoral Fellow, Christoph Spiess lab, Genentech Research Experienced South San Francisco, California
We are seeking a talented postdoc to join the Antibody Engineering Department. The group is interested in engineering antibodies for new delivery strategies to cellular compartments and tissues previously poorly accessible to antibodies and/or the recruitment of unique properties to endow therapeutic molecules with novel or superior activities. The engineering of antibody variants will be carried out through rational design or display techniques. Subsequent cellular assays will validate successful engineering.

Information about the postdoctoral program at Genentech can be found at http://www.gene.com/careers/academic-programs/postdocs.

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3/26/17 Senior Manager - Compliance Experienced South San Francisco, California

Position Summary:

·       The Manager/Senior Manager, Compliance Management provides leadership and management of pharmacovigilance compliance in the US Affiliate: oversight of inspection/audit activities including corrective and preventative actions, digital media compliance, compliance metrics tracking and review, and deviations. This individual manages the USDS Compliance & Training staff to support all safety-compliance related activities accountable to US Drug Safety. 

 

 

Job Duties/Responsibilities:

 

·       Provides routine oversight of US Pharmacovigilance Compliance activities performed by USDS Compliance & Training (CAT) team including, but not limited to: ensuring timely and compliant USDS TRAC deliverables, ensuring appropriate oversight of US Affiliate and USDS PV compliance reports 

·       Provides oversight of review and support of corrective and preventative action deliverables to ensure highest level of operational excellence and timely compliance

·       Works with global and/or across business units to implement new global or local Inspection Readiness and Corrective and Preventative Action (CAPA) management processes

·       Works with US Medical Affairs Compliance and Regional PV Excellence Leader to perform and follow up on monthly compliance checks. Tracks trends in order to identify compliance risks

·       Determines resourcing across compliance-focused staff within USDS CAT 

·       Ensures USDS local processes and documentation are compliant with Global standards

·       Develops and strategizes innovative approaches with the Global Digital Media Governance Network and Digital Communication Committee to ensure US Affiliate Digital Media compliance 

·       Leads in the creation and implementation of Compliance Management operational strategies, goals and objectives for the CAT team

·       Maintains strong relationships and communication with key stakeholders, including Global Safety organization, Commercial leadership, PD Quality Services (PDQS) and USDS leadership to address CAT queries, share metrics, and discuss new CAT-related processes.

·       Acts as subject matter expert for Compliance Management Operational process in the event of audit or regulatory inspections

·       Participates in or leads relevant Global initiatives or work streams as needed

·       Under guidance of the Director, CAT, oversees and ensures execution of USDS-related CAPAs

·       As a member of the extended USDS Safety Leadership Team, collaborates with the leaders within USDS to drive the organizational strategy, goals, and objectives for the department

·       Manages direct reports – USDS Compliance & Training Managers (levels E3-5)

·       Accountable for coaching and developing direct reports by providing an environment that encourages ongoing personal and professional development

·       Responsible for the performance of assigned personnel against departmental processes, standards and performance goals

 

...
3/26/17 Senior Compliance Lead Experienced South San Francisco, California

The Senior Compliance Lead is responsible for all activities related to the Quality Management System oversight as well as audit and inspection readiness in the US Affiliate. The Senior Compliance Lead coordinates closely with the Compliance & Training Team (CAT) members and cross functionally to drive compliance.  The Senior Compliance Lead is responsible for compliance of strategic input and tactical implementation for pharmacovigilance activities and projects, identify and communicate compliance risks, oversee action plans to mitigate risks (if applicable). This role reports directly to the Senior Compliance Manager.

 

Senior Compliance Lead performs the following:

 

CAPA Management:

• Evaluates and develops corrective and preventative action deliverables to ensure highest level of operational excellence and timely compliance

• Develops feasible solutions to deviation/audit/inspection findings or gaps and manages CAPA projects

• Identifies SMEs across USDS and USMA to support CAPA deliverables

• Coordinates and implements project management structure across multiple CAPA projects

• Plans and guides SMEs to deliver appropriate evidence to meet criteria for CAPA closure

• Coordinates closely with SMEs and relevant stakeholders to manage and influence CAPA resolution

• Assesses incoming deviations and accurately updates dashboards and tracking tools in a timely manner


Audit and Inspection Readiness:

• Establishes and implements inspection readiness processes

• Minimizes PV risks through pulse checks to evaluate current process design

• Identifies PV gaps and solutions to address the risks related to those gaps

• Develops internal processes to effectively manage audits and inspections

• Conducts mock audits and inspections

• Analyzes audit and inspection findings and prepares CAPA plans

• Educates relevant staff in the US Affiliate and high risk functional areas on audit/inspection readiness and CAPA management

• Conducts lessons learned sessions following audits and inspections to continuously iterate on current processes


PV Content Compliance:

• Provides PV guidance on digital media compliance across the US Affiliate

• Develops and strategizes approaches with the Global Digital Media Governance Network and Digital Communication Committee to ensure US Affiliate Digital Media compliance

• Coordinates and supports GNE sponsored websites/social listening and GNE Customer Relationship Management (CRM) databases on AE reporting and global PV requirements

• Directs compliance metric tracking for digital media and CRMs


Risk Assessment:

Establishes compliance checks, business continuity management plan testing, vendor site visits and identifies PV compliance risks

Evaluates implementation of processes across functional groups to ensure compliance

Determines risk management plans for non-compliant processes or functional groups

Assesses risk findings and designs processes/programs to mitigate risks

Recommends process enhancements to drive overall effectiveness and/or address identified gaps

Coordinates with USDS teams to continuously update non-compliant or ineffective processes

Effectively formulates strategies, tactics and action plans to achieve results    

 

Additional Job Duties/Responsibilities:

· Conduct vendor assessments for adverse event reporting compliance

· Working with commercial organization to ensure monitoring of Genentech sponsored websites for adverse event reporting

· Monitor Information Technology issues

· Track and analyze US Pharmacovigilance metrics

· Involved in pharmacovigilance activities and projects as assigned by the Senior Compliance Manager or Director of Compliance

...

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 US.Accommodation@roche.com.

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.