|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|
|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:
|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.
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.
|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:
|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.
|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
|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.
|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.
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<...
|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:
|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:
Successful factors for the Sr./Principal Business Manager include:
|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.
|3/27/17||Therapeutic Area Lead||Experienced||South San Francisco, California|
Relocation has been designated for this 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:
Major Responsibilities and Accountabilities
|3/27/17||Operations Manager - Commercial Business Practices Group||Experienced||South San Francisco, California|
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 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.
|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:
|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.
|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.
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.
|3/27/17||Clinical Biomarker Operations Manger||Experienced||South San Francisco, California|
|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.
|3/26/17||Senior Manager - Compliance||Experienced||South San Francisco, California|
· 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.
· 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:
• 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
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...
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