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.

This position is for Swing shift (Monday – Friday 2:00pm – 10:30pm).

Main Purpose of the Position:   

• Solve a variety of routine and difficult Manufacturing Quality Assurance and product release issues following cGMP regulations and Genentech standards       
• Perform assigned tasks and work to achieve company goals and department objectives. 

Job Duties/Responsibilities:

·               Follow company policies and procedures.

·               Maintain a state of inspection readiness.

·               Provide input to the development of personal performance goals and departmental objectives.

·               Collaborate with Management to establish and meet targets and timelines.

·               Independently manage competing priorities with limited instruction.

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

·               Identify and recommend solutions to potential procedure, process and system gaps.

·               Provide assistance to customers in support of departmental functions.

·               Participate in the design and implementation of department and cross-functional initiatives.

·               Apply basic theory and technical principles to address moderately complex problems.     

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

·               Serve as a technical subject matter expert (SME) in support of department functions.

·               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.

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

Technical Duties/Responsibilities:

·               Evaluate and close complex, non-investigational discrepancies.       

·               Initiate discrepancy investigations as required.       

·               Draft and route discrepancy summaries to Discrepancy Management.         

·               Perform Assessor and Evaluation activities defined in the Discrepancy Management System (DM...

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.

 The QC Pharmaceutical Specialist will be a member of the Method Transfer, External QC, and Method Monitoring group, which is part of ROCHE/GENENTECH’s Global Method Management and Technology (Global MMTech), the department responsible for the life cycle management of all commercial methods and control systems and innovation within Commercial Biologics Quality.
Method Transfer, External QC, and Method Monitoring is responsible for all aspects of assay transfer, QC support of CMOs and partners, and method monitoring activities across ROCHE/GENENTECH’s entire commercial network, including CMOs and partners. The successful candidate will provide QC oversight of Contract Manufacturing Organizations (CMOs) who manufacture and test commercial ROCHE products.

Job Responsibilities:
The successful candidate will be responsible for managing all QC aspects at our CMOs on a global basis as the single point of contact representing ROCHE/GENENTECH. The scope of this role includes all US based CMOs that manufacture and test Commercial Small Molecule Pharmaceutical Products. Responsibilities include, but are not limited to, the following key aspects: Qualify CMO for QC testing and data review; ensure appropriate adherence to cGMP requirements at CMO; work with appropriate subject matter experts to provide support to CMO in QC related investigations and analytical method issues; participate in laboratory audits and inspections; participate on Quality Review Boards as needed; manage change control for all CMO analytical methods and laboratory impacting activities; review and approve documents; manage critical reagents/reference standard supplies for CMOs; support preparation of Annual Product Quality Reports.

The Scientist will be a member of the Protein Analytical Chemistry Validation Department (PAC-V). PAC-V is one of the seven departments that comprise Analytical Development and Quality Control  (ADQC) organization within Process Research and Development.

PAC-V  is responsible for the validation life cycle of quality control methods (covering a wide array of techniques) until established as part of a commercial control system. PAC-V is responsible for both the development and execution of the strategies. The candidate will provide practical guidance and expertise to ensure the appropriate and timely progression of acceptable validation activities across the Protein Analytical Chemistry Department.

The candidate must have in depth scientific knowledge and hands-on experience in the development, robustness testing, 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).

Additionally, the candidate is expected to be a key player in Genentech's business process for continuous innovation to identify, evaluate, and implement novel and viable state of the art analytical technologies for QC testing. The candidate is also expected to represent PAC-V in cross functional teams. The position involves a multitude of interactions within a global matrix organization, excellent communication and presentation skills are essential.

Responsibilities      

• Perform technical and compliance review of analytical testing results for bulk, final product, pre-clinical, cell banking and stability products
• Compile analytical data for bulk, final product, pre-clinical, cell banking and stability products
• Set up stability studies for clinical products in accordance internal PQS and ICH stability guidelines. 
• Plan and prioritize new stability studies to ensure regulatory submission timelines are met.
• Review and approve time point data to ensure regulatory compliance.
• Manage inventory of all stability studies, including sample submission to partner labs and cycle counting
• Assess and approve discrepancies of clinical and pre-clinical products
• Technical proficiency in analytical methodology and adherence to cGMP compliance
• Train colleagues on stability, assay review and analytical methodology as appropriate
• Identify and address gaps in systems and procedures for continuous improvements.
• Accomplish corporate, operational and departmental goals
• Exert influence in the development of objectives and long range goals of the organization
• Make independent decisions around complex issues in alignment with Roche policies
• Support internal and external audits
• Work with internal departments and outside vendors, collaborators and partners concerning projects and commitments
• Mentor and supervise (as required) other staff members on QC related, processes and projects.

Responsibilities      

• Perform Quality review and approval of method validation and qualification reports
• Perform technical and compliance review of analytical testing results for bulk, final product, pre-clinical, cell banking and stability products
• Compile analytical data for bulk, final product, pre-clinical, cell banking and stability products
• Assess and approve discrepancies of clinical and pre-clinical products
• Review and approve COA, COT and stability statements
• Technical proficiency in analytical methodology and adherence to cGMP compliance
• Train colleagues on assay review and analytical methodology as appropriate
• Identify and implement process improvements
• Accomplish corporate, operational and departmental goals
• Exert influence in the development of objectives and long range goals of the organization
• Make independent decisions around complex issues in alignment with Roche policies
• Support internal and external audits
• Work with internal departments and outside vendors, collaborators and partners concerning projects and commitments
• Meets scheduled performance of 95% on-time
• Mentor and supervise (as required) other staff members on QC related, processes and projects.

Analytical Operations provides assay support for Process Technical Development in GMP and R&D environments.  The hire will be mainly responsible for performing HPLC, CE and LC/MS assays, data processing, and development of HPLC methods. Responsibilities also include assay reagent and instrument maintenance, and assay troubleshooting.  Position requires working closely with other members of the department in a team setting, as well as extensive interaction with other departments. Handling of biological and chemical reagents is required.

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 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.

QC Associate I (N5):

This is an 18 Month Term position on the weekend shift.

Main Purpose of the Position:     Perform analytical, biochemical, and/or biological testing; data review; and/or related activities that support QC operations. 

Job Duties/Responsibilities:

• Perform a broad variety of basic and moderately complex tests with documentation according to GMP Review data and assess against established acceptance criteria and peer generated data for basic methods.
• Prepare data tables and graphs
• Identify discrepancies andparticipate in quality investigations as needed.
• Receive and provide basic training
• Participate in assay transfer and assay validation.
• Perform testing for 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.
• Meets scheduled performance of 95% on time.
• Perform other duties as requested by managers to support Quality activities.
• Works under general supervision.
• Manager provides work priorities, timelines and resources
• Instructions given on new lines of work or special assignments.
• Progress on work assignments is generally reviewed on a regular basis.

Capabilities Identified for Success:

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

SHE requirements

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…

Purpose:
• Solve a wide range of difficult validation activities and quality issues that impact multiple functions following cGMP regulations and company standards.
• Identify gaps and declining trends as well as innovate on processes and tools to simplify work and standardize practices.
• Build relationships and teamwork across departments, functions, and organizations to ensure commitment and adherence to PTQ strategies and initiatives.
• Be open-minded to diversity in people and ideas and be customer focused without sacrificing quality.
• Perform assigned tasks and work to achieve company goals and department objectives.

Accountabilities:
• Innovate and develop tools and processes to improve standard work and efficiencies.
• Build relationships to influence and dissimulate PTQ strategies, processes, and initiatives.
• Proactively identify gaps and trends in quality and compliance in order to proactive prevent decrease in compliance for inspections.
• Be open to diverse opinions, ideas, and viewpoints to be in a position to make the best decisions, plan, and executions.
• Balance between customer service and compliance without sacrificing quality standards and quality of work.
• Establish and follow company policies and procedures.
• Maintain a state of inspection readiness.
• Provide input to the development of personal performance goals and departmental objectives.
• Establish work priorities to meet targets and timelines.
• Manage competing priorities and allocate, adjust, and optimize assigned resources when applicable.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Development and 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) 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 on and author department policies or guidelines.
• 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.
• Be accountable for behaviors as described in companies Core, Common, and Critical Competencies.
• Perform any other tasks as requested by Management to support quality oversight activities

Requirements:
• Process Chance Requests related to accountable computer systems.
• Determine Change level per quality policies and appropriate training.
• Review, assess and approve IT related changes.
• Collaborate with departments to ensure validation activities are executed efficiently and effectively.
• Provide guidance to internal and external customers on best practices for executing and maintaining a validation program.
• Develop strategies for new validation projects in collaboration with system owners.
• Develop near-term and long-range plans for the group in collaboration with Management.
• Review and approve applicable validation deliverables.
• Collaborate with departments to ensure validation activities are executed efficiently and effectively.
• Present and provide rationale for the validation strategies during internal and external audits.
• Ensure the department is represented on relevant project teams.
• Identify, design, and implement validation process improvements.
• Support internal and external audits.
• Assist senior personnel in support of regulatory inspections
• B.A. or B.S degree (preferably in Life Science or Engineering) and at least ten years experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience
• Sound knowledge of cGMPs or equivalent regulations
• Ability to interpret and relate quality Standards for implementation and review
• Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
• Ability to communicate clearly and professionally both in writing and verbally
• Flexibility in problem solving, providing direction and work hours to meet business...

The Position

• Perform final review, cumulative review and disposition of Genentech manufactured cell banks and clinical drug substance, drug product and final drug product.
• Review and approve procedures, tickets and other clinical QA controlled documentation. 
• Provide clinical trial support such as COA/COC/COT requests.
• Provide support and oversight of manufacturing activities on the floor.
• Manage batch disposition activities to ensure that products are dispositioned in accordance with cGMPs, Regulatory, and Genentech Policies and Procedures and adherence to schedule.  
• Set personal performance goals and collaborate with management to establish organizational objectives.  
• Manage competing priorities to meet department and organizational targets and timelines.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Apply advanced theory, technical principles, and judgment to address a broad range of difficult problems.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
• Be accountable for behaviors as described in Genentech's Core, Common, and Critical Competencies.
• Perform any other tasks as requested by Management to support Quality oversight activities.
• Interface with appropriate departments to ensure that batch disposition items are complete and timely notification to Management of all known delays and significant Quality issues is provided
• Interact with interdepartmental contacts on discrepancy assessment, resolution, and Quality approval
• Support and present in Internal and Regulatory Inspections.
• Participate in the resolution of Quality issues by fostering effective interdepartmental and cross-functional relationships.
• Participate or lead different internal or cross functional projects relevant to QA lot disposition
• Train new personnel and internal customers on relevant business processes.
• Ability to revise or create work instructions, SOPs and business process instructions.

The Position

• Perform final review, cumulative review and disposition of Genentech manufactured cell banks and clinical drug substance, drug product and final drug product.
• Review and approve procedures, tickets and other clinical QA controlled documentation. 
• Provide clinical trial support such as COA/COC/COT requests.
• Provide support and oversight of manufacturing activities on the floor.
• Manage batch disposition activities to ensure that products are dispositioned in accordance with cGMPs, Regulatory, and Genentech Policies and Procedures and adherence to schedule.  
• Set personal performance goals and collaborate with management to establish organizational objectives.  
• Manage competing priorities to meet department and organizational targets and timelines.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Apply advanced theory, technical principles, and judgment to address a broad range of difficult problems.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
• Be accountable for behaviors as described in Genentech's Core, Common, and Critical Competencies.
• Perform any other tasks as requested by Management to support Quality oversight activities.
• Interface with appropriate departments to ensure that batch disposition items are complete and timely notification to Management of all known delays and significant Quality issues is provided
• Interact with interdepartmental contacts on discrepancy assessment, resolution, and Quality approval
• Support and present in Internal and Regulatory Inspections.
• Participate in the resolution of Quality issues by fostering effective interdepartmental and cross-functional relationships.
• Participate or lead different internal or cross functional projects relevant to QA lot disposition
• Train new personnel and internal customers on relevant business processes.
• Ability to revise or create work instructions, SOPs and business process instructions.