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

...

The Principal Research Associate within the Biological Technologies group in Analytical Development and Quality Control will be responsible for all aspects of automation for all phases of clinical trials utilizing precision robotics.  The Sr QC Associate will support the execution of vendor IQ, OQ/PQ documents, write and execute instrument, assay validation protocols and IQ, OQ/PQ documents.  The associate will also support the development of R&D assays onto high throughput automation platforms utilizing liquid handlers, plate readers and high content analysis instruments.  The candidate will identify and evaluate new technologies and work collaboratively with different research and development departments.  Expectations will also include writing test procedures, SOPs, protocols, technical reports, and summarizing/presenting data.  Additional responsibilities may include presentation of data at internal and external meetings, as well as reports in support of IND/BLA regulatory filings, and supporting collaborations with other groups/sites.
...

The job responsibility within the Biological Technologies group in Analytical Development and Quality Control, is to develop, qualify/validate, and troubleshoot biochemical/immunochemical and cell-based assays for clinical and to-be-marketed products.  The candidate will perform testing as needed in support of process development, stability, and lot release according to established test procedures..  Expectations will also include some routine lab maintenance, participate in writing SOPs, test procedures, and participate in training, performing testing, troubleshooting, and/or validation of immunological and cell-based potency methods.  Additional responsibilities may include presentation of data at internal meetings and participating in the evaluation of new equipment and technologies. ...

 

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.

...

 

• Lead and/or participate in tech transfers of purification processes across Roche/Genentech’s drug substance manufacturing facilities and to external contract manufacturing facilities.  Requires close collaboration with cross-functional team to implement, validate, and license Drug Substance processes at receiving sites.
• Responsible for providing on-going technical support for Drug Substance production at contract and partner sites. Includes monitoring process performance, resolving manufacturing deviations, participating in quality investigations, and providing technical approval of document and automation recipe changes to support continuous process improvement.
• Lead and/or participate in global initiatives and cross-functional teams in the areas of downstream processing.
• Work collaboratively with site Manufacturing Science and Technology (MSAT) groups to develop and communicate best practices for process design and operations to ensure consistency and compliance across the biologics manufacturing network.
• Represent MSAT Network on corporate initiatives led by partner groups such as Quality, Regulatory, Manufacturing Operations, Pharma Technical Development, etc.
• Provide technical leadership for topics including support for proposed manufacturing process changes, process validation, discrepancy and investigation evaluations, change control, and regulatory submissions. Some lab work may be required in order to resolve investigations and/or demonstrate proof-of-concept for proposed process changes.
• Responsible for authoring and reviewing technical reports, manufacturing instructions, process validation documents, and portions of regulatory submissions to support licensing processes at new manufacturing sites.
• Travel within the Roche network and to contract manufacturing sites will be required.

 

 

 

...

The In Vivo Studies group is seeking a team-oriented, highly motivated individual to participate in the technical conduct of in vivo studies in a high-throughput work environment. This unit of the Safety Assessment Department is responsible for the planning and execution of pre-clinical drug development studies (including pharmacokinetics and toxicology) supporting a large customer base.

Responsibilities:
Studies include (but are not limited to) work with chemotherapeutics, radioisotopes and other potentially hazardous materials. The individual will have to perform applicable techniques requiring a high-degree of manual dexterity (cannula implantation, catheter insertion, drug administration, blood collection, restraint, anesthesia, euthanasia) in common in vivo models. Maintain study-related documents and follow departmental SOPs to ensure study integrity and quality. Assume role of study coordinator for selected studies and write preclinical protocols as appropriate. This job will involve a high level of physical activity.
...

The Clinical Pharmacology Department at Genentech, Inc. is seeking aPh.D. level scientist who is driven to understand the Clinical Pharmacokineticsand Pharmacodynamics of novel drug candidates in the area of Oncology. This individual will lead and support Clinical Pharmacology activities ofAntibody Drug Conjugates across all phases of clinical development.  Thisperson will have responsibility for the Clinical Pharmacology Strategy toensure that appropriate dose/route/schedule decisions are made using state ofthe art modeling and simulation strategies that are aligned with projectneeds.  This will be accomplishedby working in close partnership with Clinicians, Biostatisticians and projectteams 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) andpresentation of data at cross-functional teams, department meetings, conferencesand regulatory meetings (worldwide). Additionally this individual will also bedirectly involved in leading project sub-teams and representing the function atcross-functional project teams....

The Clinical Pharmacology Department at Genentech, Inc. isseeking a Ph.D. level Senior Scientist who is driven to understand the clinicalpharmacokinetics and pharmacodynamics of novel drug candidates in the area ofOncology.  This individual will beresponsible for the clinical PKPD activities of Biologics, Antibody DrugConjugates and/or Small Molecules in clinical development. This person willhave responsibility for the Clinical Pharmacology strategy in order to ensurethat appropriate dose/route/schedule decisions are made using the state of theart 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.  Responsibilitieswill include planning and reviewing study designs, analysis plans, data analysis,interpretation of PK/PD as well as planning, implementation and organization ofregulatory filings (worldwide) and presentation of data at cross-functionalteams, department meetings, conferences and regulatory meetings (worldwide).Additionally this individual will also be directly involved in leading projectsub-teams and representing the function at cross-functional project teams.

...

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.

...

The Country Study Manager (CSM) provides leadership to one or more Study Management Teams (SMTs) and provides strategic planning and organization to achieve successful study completion. The CSM maintains full ownership of the US Medical Affairs portion of a study and ensures the effective and efficient delivery of the operational aspects in accordance with the medical plan and ICH/GCP standards, Roche SOPs, local operating guidelines and local regulatory requirements. The CSM also ensures the development and maintenance of productive relationships with our customers.

 

Responsibilities:

 

- Provides Direction and Leadership to one or more SMTs

- Establishes Study Timelines, Budget, Resource, Risk and Quality Plans

- Manages the Delivery of Study Activities in Order to Meet Study Plans

- Builds effective, high performing SMTs through influence, integration, motivation and optimization of team performance.

- Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders, eg, Pharma Business

- Functions as Study Management Team Leader.

- Maintains awareness of external clinical research practices to ensure the SMTs are aware of the risks, priorities, value and impact of their work and contributions.

- Provides input into the study synopsis, development of the final protocol, feasibility conduct and all study specific documents and procedures.

- In accordance with the overall medical plan, establishes and maintains accurate study level plans in designated resourcing and planning system.

- Is accountable for the development and active management of the study patient recruitment strategies in US Medical Affairs.

- Develops Partnership with Business, participates on local life cycle teams, consults local Business Units, and participates in local Business Unit meetings as necessary.

- Is accountable for the selection, training and direct management of external suppliers supporting US Medical Affairs trials.

 

- Ensures that data is delivered in accordance with established dataflow timelines.

- Develops/maintains investigator relations, builds and maintains a professional relationship between Roche and Investigator, participating in Investigator Meetings as necessary.

- Monitors progress against SMT goals and takes appropriate action to ensure goals are met and issues are communicated with the appropriate persons or teams.

- Oversees the management of the Clinical Operations studies budget.

- Leads the evaluation of standards across one or more SMT(s) with the objective of enhancing quality, productivity and efficiency. 

...

 Purpose: 

The Genentech Research and Early Development (gRED) Clinical Program Leader (CPL) position is accountable for operational strategy for assigned early development programs. The CPL is accountable for functional management including recruiting, building and maintaining a high quality gRED Clinical Operations organization. 

Primary Accountabilities and Responsibilities: 

Program Management Responsibilities: 

Through appropriate leadership, direction and operational expertise, lead the development and execution of operational strategies for multiple molecules/programs in Genentech’s early development portfolio: 

• Represent Clinical Operations on the Early Development Teams (i.e. Core, Development or Clinical Sub-Teams) 

• Develop program timelines and budgets and manage variance 

• Provide strategic, operational input to clinical development plan (CDP), target product profiles (TPP) and project plans 

• Lead the Clinical Operations team to ensure effective development, implementation and execution of all clinical trials within agreed timelines, resources and budget 

• Develop and present operational plan to management review bodies 

• Identify program risks and develop and implement mitigation strategies for assigned programs 

• Define the resourcing and outsourcing strategy for early development programs 

• May participate in Business Development assessments 

• Work collaboratively, effectively, and efficiently with all internal and external partners and stakeholders 

• Partner with Business Management to identify strategic business needs to support the clinical programs 

• Partner with late-stage development leaders to ensure strategic alignment on the CDP 

Functional Management Responsibilities: 

Identify, recruit, hire, and develop Clinical Operations staff, as well as oversee their work to ensure all department goals, deliverables, and objectives are met. Additionally, contribute to the Clinical Operations organization. These responsibilities include: 

• Manage Clinical Operations staff including development, coaching, mentoring, performance management, and succession planning 

• Ensure that employees are appropriately trained and comply with company and regulatory standards 

• Create a positive work environment by encouraging mutual respect, innovation and accountability 

• Resource projects to enable teams to meet deliverables 

• Create and maintain Clinical Operations as a ‘great place to work’ 

• Participate in and/or lead working groups and/or initiatives within the gRED organization or cross functionally as required 

• Partner with Process and Training Management (PTM) to optimize and continually improve processes; to create and maintain role definitions and standards; and to develop role-based competency and training programs 

• Create an environment supporting innovation and smart risk to help the department continuously evolve, improve and excel *LI-EK1

...

Provide accurate and effective administrative support Managers within the group, and coordinate administrative duties with other Administrative Associates to provide seamless support for the group. Identify and anticipate needs of the group and plan work activities accordingly. Look for areas of activity overlap with co-workers and leverage resources to maximize time, resources and dissemination of information. Manage multiple schedules with heavy calendaring of complex meetings. Arrange, coordinate and support meetings, events, and activities both on and off-site. Generate, disseminate and maintain documents and information. Develop, implement and evaluate department work processes and procedures. Manage deadlines related to business planning as well as other special projects. Collaborate with Admin team to support complex projects and deadlines General office responsibilities include but not limited to: Schedule and coordinate staff onsite/offsite meetings, create and prepare presentation materials, assist with special projects, schedule travel for staff, process payment and expense reports, maintain files, order department office supplies, maintain photocopying equipment, order catering and other supplies for a variety of meetings and events, greet visitors, disseminate information, fully utilize PC and software applications. Ensure compliance with policies Integrate and facilitate communication with individuals, the team, the department and other functions across the company Attend and actively participate at staff level meetings as required, coordinate/publish agenda and minutes from meetings Integrate and actively participate in administrative associate team meetings and projects as requested The ideal candidate will succeed not just by completing tasks, but by proactively working to maximize the effectiveness of the managers and otheradministrative\nassociates in the group. Provide judgment in sensitive, confidential and complex information. Flexibility to take direction on projects from team and co-workers and work projects yet demonstrate autonomy in managing time and priorities. Proactive problem solving and decision-making within agreed parameters. Customer service orientation. Demonstrated successful experience indicating attention to detail, ability to work independently and in teams, strong follow up skills and ability to manage multiple projects simultaneously. Individual must possess strong, positive interpersonal skills and have the ability to work with diverse individuals. Must be willing and able to handle large volume of routine work, as well as more challenging projects and provide a consistently accurate work product.

...