The Clinical Pharmacology Department at Genentech, Inc. is seeking a Ph.D. level Associate Scientist or Scientist who is driven to understand the clinical pharmacokinetics and pharmacodynamics of novel drug candidates in the area of Biologics.  This individual will be primarily responsible for the clinical pharmacology activities of Biologics in clinical development. This person will have responsibility for the Clinical Pharmacology strategy in order to ensure that appropriate dose/route/schedule decisions are made using the state of the art modeling and simulation strategies that are aligned with project needs. This will be accomplished by working in close partnership with Clinicians, Biostatisticians, Clinicians and project teams.  Responsibilities will include planning and reviewing study designs, analysis plans, data analysis, interpretation of PK/PD as well as planning, implementation and organization of regulatory filings (worldwide) and presentation of data at cross-functional teams, department meetings, conferences and regulatory meetings (worldwide). Additionally this individual will also be directly involved in leading project sub-teams and representing the function at cross-functional project teams.

The Clinical Pharmacology Department at Genentech, Inc. is seeking a Ph.D. level Scientist who is driven to understand the clinical pharmacokinetics and pharmacodynamics of novel drug candidates in the areas of Oncology, Immunology and/or CNS . This individual will be responsible for the clinical pharmacology activities of delivering Small Molecules in clinical development. In addition to having responsibility for the Clinical Pharmacology strategy to ensure that appropriate dose, route, and schedule decisions are made using the state of the art modeling and simulation approaches. This will be accomplished by working in close partnership with Clinical Science, Clinical Operations, Regulatory, Biostatisticians and other functions which make up project teams. Other responsibilities will include planning and reviewing study designs, PK/PD data analysis and interpretation of analysis, as well as planning, preparation and implementation of clinical pharmacology sections, and organization of regulatory filings (worldwide). Clinical Pharmacologists at Genentech often present data at cross-functional teams, department meetings, conferences and regulatory global health authority meetings (worldwide). Additionally, this individual will also be directly involved in leading interdisciplinary sub project teams and representing the function at cross-functional project teams.

• Perform testing of routine and non-routine samples and document according to GMP.
• Perform environmental monitoring and utilities sampling and document according to GMP.
• Review data and assess against established acceptance criteria.
• Perform technical review of peer-generated data for basic methods.
• Prepare data tables and graphs.
• Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiatives as needed.
• Receive and provide training.
• Participate in assay transfer and assay validation as needed.
• Perform equipment qualification / maintenance.
• Prepare and maintain standards, controls, stocks, and cultures per established procedures
• Support the maintenance and compliance of operational areas.
• Assure and apply GMP throughout operations.
• Coordinate with supplier/customers to support operational activities.
• Support internal and external audits.
• Work to meet schedules.
• Identify and support resolution of technical problems. Resolve sample issues as needed.
• Actively participate in group and project teamwork; projects and process improvements.
• Draft protocols and reports under supervision.
• Meets scheduled performance of 95% on time (ATS).
• Perform other duties as requested by managers to support Quality activities.

The candidate will be a member of the Analytical Chemistry group in the Method Management and Technology (MMTech) Function within Genentech’s Corporate Quality Organization.  MMTech is the scientific and technical Center of Excellence for commercial quality control methods, specifications/control systems and reference standard and provides support to the Roche/Genentech Global Quality Control Network for the commercial biotech product portfolio. We are looking for an experienced Scientist to play an integral part in providing and supporting analytical chemistry methods (e.g. HPLC, CE) used for quality control purposes.

MAIN PURPOSE OF THE POSITION

• Responsible for method troubleshooting and optimization in support of life-cycle management of methods for Roche/Genentech commercial biotech products
• Develop and execute experiments for the development, validation, implementation of QC test methods for commercial biologic products following cGMP regulations, regulatory guidelines as well as local and global quality standards.
• Support regulatory submission and inspections: through authorship of CMC subsections, responses to questions and direct interactions

JOB DUTIES/RESPONSIBILITIES

• Serve as analytical technical lead/representative (biotech products) on cross-functional and multi-site project teams.
• Ensure on-time delivery of controlled documents, reports and method packages to support project timelines.
• Apply technical knowledge, scientific experience and expert judgment to address a broad range of difficult problems.
• Troubleshoot and direct the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of departmental functions.
• Perform assigned tasks and work to achieve company goals and department objectives.
• Train personnel and internal customers on relevant business processes.
• Support the development and administration of Quality Control and laboratory training materials.

The job responsibility within the ADQC--Biological Technologies Testing Group is to perform cell-based and immunochemical/biological assays in support of process development, stability, and lot release testing with established procedures in a GMP environment.  Role includes reviewing assay packets and releasing assay data as well as prepare assay reagents, generate computer results, monitor assay quality, use of LIMS, maintain the lab via Lean tools such as 5S and EHS safety practices.  Expectations include lab maintenance and project support/equipment qualification/computer systems/document management as needed.

The job responsibility within the ADQC--Biological Technologies Testing Group is to perform cell-based and immunochemical/biological assays in support of process development, stability, and lot release testing with established procedures in a GMP environment.  Role includes reviewing assay packets and releasing assay data as well as prepare assay reagents, generate computer results, monitor assay quality, use of LIMS, maintain the lab via Lean tools such as 5S and EHS safety practices.  Expectations include lab maintenance and project support/equipment qualification/computer systems/document management as needed.

This is an exciting opportunity within the Drug Substance Global Biologics Manufacturing Sciences and Technology (DS GBMSAT) department in the Pharma Technical Development organization.  GBMSAT provides technical leadership to develop solutions in support of commercial manufacturing across the internal and external Roche network.  GBMSAT plays a critical role in enabling the network concept for the MSAT network across Roche.   Additionally, GBMSAT provides technical leadership for technology transfers to contract manufacturing organizations.

Job Duties/Responsibilities:

• Perform microbiological, biochemical and analytical lot testing of raw materials, E. coli and mammalian cell banks, commercial and clinical fermentation, purification, and final product samples according to GMPs.
• Review data and assess against established acceptance criteria. 
• Evaluate data to identify trends and/or establish limits. 
• Identify gaps in and potential improvements to systems and procedures. 
• Perform equipment qualification and or maintenance. 
• Prepare and maintain standards, controls, stocks, and cultures per established procedures. 
• Assure and apply GMP throughout all operations. 
• Coordinate with customers to support multi-site operational activities. 
• Present analytical procedures and results during internal and external audits and regulatory inspections.
• Participate in and/or lead projects and process improvements. 
• Perform other duties as requested by managers to support Quality activities. 
• Works to meet schedules, timelines and deadlines. 
• Meets scheduled performance of 95% on time.

Technical Duties/Responsibilities

• Write technical protocols and reports under limited supervision. 
• Identify and propose resolutions for study or project deviations. 
• Provide input to and participate in assay transfer and assay validation.
• Perform technical review of data derived from complex tests. 
• With limited supervision, design and execute quality investigations and CAPA (corrective actions preventive actions) initiatives as needed. 
• Identify, troubleshoot, and propose resolution to technical problems. 
• Identify and propose resolution for discrepancies. 

Job Summary:

Perform analytical, biochemical testing and related activities to support QC operations

Description:

Must have flexible schedule, 4x10 day shift schedule. This role will require working major holidays.

Perform analytical, biochemical, and/or biological cell based testing of commercial and clinical in-process, drug substance, drug product and stability samples to meet standard lead times to support Quality Control Bioanalytical  / In-Process operations. 

Technical Duties/Responsibilities:
•Perform testing of routine and non-routine samples (e.g. Spectrophotometry, pH, HPLC) and document according to GMP.
•Review data and assess against established acceptance criteria
•Perform technical review of peer-generated data for basic methods
•Prepare data tables and graphs
•Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiatives as needed.
•Receive and provide training
•Participate in assay transfer and assay validation.
•Perform equipment qualification / maintenance
•Prepare and maintain standards, controls, stocks, and cultures per established procedures
•Support the maintenance and compliance of operational areas.
•Assure and apply GMP throughout operations.
•Coordinate with customers to support operational activities.
•Support internal and external audits.
•Work to meet schedules.
•Identify and support resolution of technical problems.
•Actively participate in group and project teamwork; project and process improvements.
•Drafts protocols and reports under supervision.
•Meets scheduled performance of 95% on time.
•Perform other duties as requested by managers to support Quality activities.

Note:
•Position may involve use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
•Must be able to lift up to 10 lbs
•Repetitive pipeting

Note: This position is posted as E3/E4 depending on skills and experience.

The job takes place in an office environment and requires computer use >4 h/day, prolonged sitting, and repetitive motion (keyboarding, mousing, etc.). Occasionally job requires lab investigation and potential exposure to a number of chemicals, including but not limited to: acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.

Main Purpose of the Position:

·         Provide commercial and clinical product support to ensure highest level of compliance, uninterrupted supply to patient, and continuous improvement in business processes and methods.

·         Represent Quality Control in Product Quality Teams

·         Draft Annual Product Quality Report and Annual Trend Report

·         Ensure Quality Control is ready to execute commercial & clinical manufacturing campaigns

·         Ensure effective corrective and preventive actions are systematically identified, analyzed, implemented and documented to prevent recurring problems and improve product and process quality.

·         Perform tasks and work to achieve company goals and organizational objectives.

Job Duties/Responsibilities:

• Apply extensive theoretical and cross-functional expertise in the context of company objectives to independently address complex problems
• Subject matter expert in test methodology, systems, or operational process
• Review data and assess against established acceptance criteria
• Perform technical review of data derived from complex tests, including those outside their primary area of expertise
• Evaluate data to identify trends and/or establish limits
• Identify and resolve discrepancies. Design and execute quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
• Review and approve technical / investigation reports.
• Identify, troubleshoot, and solve technical problems.
• Independently identify and lead process improvements and develop resolution of complex gaps.
• Provide input to and oversight for assay transfer and assay validation
• Act as a subject matter expert for equipment qualification and maintenance requirements, as assigned.
• Assure and apply cGMP throughout operations
• Design, develop, and/or approve training material. Receive and provide training as necessary.
• Lead collaborations to support complex and/or multi-site projects
• Serve as subject matter expert in internal and external audits and regulatory inspections
• Write protocols, procedures and reports
• Meets scheduled performance of 95% on time.
• Perform other duties as requested by managers to support Quality activities.
• Interacts with senior internal and external personnel on significant matters.
• Represents organization as a prime contact on initiatives and projects.
• May provide guidance and coordinate work activities of other personnel.
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact.

Capabilities Identified for Success:

• Accountability
• Attention to Detail
• Communication
• Organization and Prioritization
• Policies, Process, Procedures
• Teamwork

Position Summary:

The Commercial Control System Lifecycle Management function of MMTech at Genentech has an open position for a QC Scientist/Senior QC Scientist to support lifecycle management of commercial biologics control systems.  This position is part of a function responsible for developing and implementing strategies to systematically evaluate and update control systems for the Genentech/Roche product portfolio.   

MMTech is part of the Genentech/Roche commercial quality organization and is responsible for method validation, control systems and specifications, reference standards, assay transfers, and providing scientific/technical support for the global QC Network across the commercial biotechnology product portfolio.

Job Description:

The individual will support the development, implementation, and maintenance of strategies to systematically assess and update commercial product control systems.  He/she will manage product, process, and external knowledge to ensure that control systems reflect current product and process understanding, analytical technologies, and Health Authority expectations.  The individual will be responsible for contributing to reports that document information supporting control system assessments and revisions.

As part of the control system evaluation and revision, this individual will:

• Oversee comprehensive control system assessments based on: identification of critical quality attributes, method and process capabilities, current industry practices, and contemporary Health Authority expectations
• Lead cross functional technical teams that perform detailed physicochemical characterization, method development/validation, and sample testing so that control system revisions are effectively managed and aligned with present-day requirements
• Provide scientific input and technical oversight to support control system changes
• Partner with subject matter experts to identify and complete key activities required for control system updates
• Collect and analyze results from product release and stability testing for use in evaluating and updating specification acceptance criteria
• Provide technical review and approval of analytical control system cGMP documents
• Support and coordinate quality assurance activities/reviews in Quality systems (e.g. Change Control, Discrepancy Management, etc.) to ensure compliance to procedures, current GMPs, and regulatory requirements
• Support regulatory submissions and inspections through authorship of relevant CMC sections, written responses to agency requests, and direct interactions with Health Authorities

Applicants should be comfortable working both independently and collaboratively as part of a team. The position offers opportunities for professional and scientific growth in a dynamic work environment.

E2/E3 position depending on experience of candidate.

Perform microbiological testing of raw materials, E. coli and mammalian cell banks, commercial and clinical fermentation, purification, and final product samples to meet standard lead times.  Review data and assess against established acceptance criteria.  Identify discrepancies, participate in quality investigations and CAPA initiatives as needed.  Participate in assay, facility, equipment and process validation. Perform equipment qualification and maintenance activities.  Support nonroutine microbiological projects and studies.  Prepare and maintain standards, controls and stock cultures per established protocols.  Support the maintenance and compliance of operational areas.  Assure strict adherence to cGMPs throughout operation.  Ensure training qualifications are up to date.  Identify and support resolution of technical problems.  Actively participate in group projects and process improvements.  Perform routine maintenance duties to ensure inspection ready state.  Draft protocols and reports under supervision.  Work with internal and external groups to develop methods for clinical products for in process and final products testing.

·         Follow company policies and procedures and be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies

·         Lead product complaint investigations with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards.

·         Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.

·         Develop solutions to complex product complaint issues and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards. 

·         Ensure appropriate application & integration of cGMPs in the product complaints management system.

·         Set personal performance goals and provide input to departmental objectives.

·         Establish work priorities to meet targets and timelines and manage competing priorities/

·         Serve as the Quality representative on cross-functional and multi-site teams.

·         Identify, design, and implement process and system improvements.

·         Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

·         Develop, train, and mentor personnel and internal customers on relevant business processes.

·         Collaborate and author department policies and procedures.

·         Make decisions that impact the goals and objectives of the department.

·         Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. 

·         Inform management of critical product complaints and provide timely impact assessments of potentially affected products, materials or processes.

·         Review and approve product complaint investigation reports and supporting documentation. 

·         Lead collaboration with departments to establish appropriate, efficient, and timely investigation strategies.

·         Educate departments on the best practices for conducting investigations and root cause analysis.

·         Lead project teams to resolve deficiencies identified through the root cause analysis process.

·         Assess the accuracy of root cause determinations based on a thorough evaluation of possible failure modes.

·         Present product complaint records and/or reports during periodic audits and regulatory inspections.

·         Perform any other tasks as requested by Management to support Quality oversight activities

This is a 2 year TERM position:

The primary responsibility of this position will be to report to the
operations Sr. Manager in charge of a global group that executes
testing (cell based and PCR based platforms) for adventitious agents,
i.e., virus, mycoplasma in CHO-derived products following established
procedures and in compliance with cGMP’s.  The position will require
work in the laboratory executing the test methods for both routine lot
release and validation of the methods on a product specific bases.
The analyst in this position will be expected to execute other QC
laboratory related activities with other team members like sampling
handling, equipment maintenance and review of QC batch test records
and certificates of analysis.  The position will also be expected to
author study reports and draft protocols for approval on validation
and/or investigational studies, review and/or author discrepancy
protocols and assessments.  Opportunities for participation as a
trainer on various topics related the detection methods utilized in
the lab, regulations that govern the use of those methods and topics
about Quality and compliance will also be available.

Note: Position can be filled as a QC Pharmaceutical Specialist II (E4) or Sr. QC Pharmaceutical Specialist (E5) based on education and experience.

QC Pharmaceutical Specialist II Role
The QC Pharmaceutical Specialist is a member of the senior technical staff of the QC Microbiology/Environmental/Molecular team specializing in environmental/utility monitoring support for biotech drug substance production and aseptic filling.

Main Purpose of the Position:   
• Develop solutions to complex Environmental/Utility monitoring activities and issues.
• Lead Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards. 
• Perform tasks and work to achieve company goals and organizational objectives.

Job Duties/Responsibilities:
• Follow company policies and procedures.
• Set personal performance goals and provide input to departmental objectives.
• Establish work priorities to meet targets and timelines.
• Manage competing priorities and allocate, adjust, and optimize assigned department resources.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Manage department and cross-functional initiatives.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) for Environmental/Utility Monitoring in support of department functions.
• Develop and train personnel and internal customers on relevant business processes.
• Mentor junior personnel serving as a subject matter expert (SME) on Quality systems, processes and issues.
• Collaborate and author department policies and procedures.
• Make decisions that impact the goals and objectives of the department.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
• Meets scheduled performance of 95% on time.
• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Provide technical expertise in the development of test method validation protocols and supporting procedures.
• Ensure validated methods and supporting procedures adhere to approved regulatory specifications.
• Prepare validation summary reports for test method validation activities.
• Provide input into regulatory filings.
• Participate in internal and external audits and regulatory inspections.
• Perform Quality Control testing for product release.
• Support quality investigations for testing and method discrepancies.
• Oversee equipment validation for laboratory instruments used in cGMP testing activities.
• Identify, initiate and approve change records to GMP controlled documents and electronic systems as appropriate.
• Collaborate with departments to ensure product release requirements are completed.
• Communicate testing, scheduling, or Environmental/Utility Monitoring issues that may impact the timely release of final product to Quality Control Management.
• Compile trending reports for method validation, testing activities and Environmental/Utility Monitoring.
• Develop and deliver training materials for new and revised test methods and laboratory procedures.