The Network Operations Manager will be responsible for providing leadership and technical guidance to a team of Network Engineers throughout North America. He/She will ensure timely response to all alerts, resolving or escalating issues as appropriate while working closely with internal customers to assure continued quality of service. The Network Operations Manager will lead various transformative Network initiatives (Network redesign, infrastructure upgrades, new buildouts), both strategic and tactical in nature, that will address our most important challenges including scalability, stability, and an increasingly complex network. He/she will manage the network in accordance with identified service level agreements (SLA), KPIs, policies, and procedures.  This individual is key in maintaining the highest level of service for our customers, both internal and external.  Additional responsibilities include:

• Delivery services include long range planning, project management, internetworking, network monitoring, capacity planning, asset management, problem management and change management.
• Project responsibilities include managing the North America Network project portfolio approval process; managing project managers and their project activities; monitoring project status; acting as an escalation point for risk mitigation and issue resolution; and tracking project deliverables, schedule and budget to ensure successful project outcomes. 
• Develops annual budgets, and life cycle maintenance projects in order to maintain the corporate network infrastructure.
• Works with our Network Architecture and Engineering organizations to develop initiatives to ensure the strategic fulfilment of business needs, lifecycle management, and continuous improvement, as well as overall customer experience and satisfaction for a specific solution.
• Is responsible for leading (and providing direction for) many vendor initiatives, contracts, and service negotiations. Works closely with vendors, monitoring service delivery, evaluating new technologies, products and services to better position the company from a data networking perspective.
• Constantly reviews and refines support documentation, processes, and procedures. 
• Reports on SLAs and metrics for the performance of the network

...

We are seeking a Project Manager who will manage projectsto successful and timely decision points from Late Stage Research throughProof of Concept.  The Project Manager will contribute to the definitionof project strategy and guide the project core and sub teams to deliver onproject objectives.  This position will be accountable for steering drugdevelopment teams through corporate processes.  Additionalresponsibilities include but are not limited to the following:

 

·        Establish and maintain functionally integrated project schedulesto enable accurate project, financial and portfolio analyses and ensureaccurate inputs are provided into business planning processes; Ensuresalignment with project sub-teams and functional partners

·        Oversees and prepares project team budget including resources andcosts collaborating with Finance and other cross-functional departments

·        Communicate, document, and archive project team activities anddecisions; act as a primary contact for project team related information

·        Facilitate project team meetings, cross-functional communicationand decision making, ensuring alignment with internal and external stakeholders

·        Identifies, recommends and implements opportunities forstreamlining team and business processes.

·        Partnerswith the team leader to ensure the team achieve and maintains a high-level ofsustainable performance, by contributing to appropriate team management bestpractices.  

...

• Provide QA oversight, support and execution of validation/qualification activities pertaining to Investigational Medicinal Products (IMP, a.k.a. clinical) GMP manufacturing equipment and analytical instruments, including preventive maintenance and requalification activities.
• Provide technical review and approve quality risk management and validation/ qualification deliverables for small molecules and biologics equipment qualification, ensuring proper design and execution.
• Ensure that equipment and systems remain in a validated state, and that validation master plans and their related documents are accurate and current.
• Develop strategies and act as project manager for new projects in collaboration with system owners.
• Develop near-term and long-range plans for the department in collaboration with Senior Management.
• Provide technical assessment and approval for GMP changes.
• Assess equipment-related discrepancies and provide input to investigations.
• Apply expertise of compliance requirements to maintain an inspection-ready state.
• Participate in audit/inspections as a subject matter expert.
• Support implementation and provide stakeholder feedback and input to the integrated Pharmaceutical Quality System (PQS) documents.
• Perform tasks and work to achieve company goals and organizational objectives.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Provide guidance to internal and external customers on best practices for generating and executing validation protocols.
• Provide input into investigations involving GMP related failures.
• Develop and implement process and system improvements, including contributing to the development of new concepts, techniques and standards.
• Advise other IMP QEV staff members on Validation related processes and projects.
• Supervise/oversee temporary or contract staff, as required.

...

The Senior Finance Business Partner will support senior leaders in Technical Regulatory and Quality and Compliance (RQC).  Quality & Compliance, the broadest Functional Unit of the PT network, spans the Biologics, Small Molecule and Contract Manufacturing Operating Units.  As a business partner, you will contribute a business perspective as a member of the leadership teams and drive the planning, reporting and ad hoc financial analyses to support each of these leaders and their teams.  This position is focused on global controlling but has significant local controlling responsibilities, too.  The successful candidate will be seen by his/her business partners as a thought leader in financial issues and a “go to” person for financial / business advice. 

This position, based in South San Francisco, will report to the Head of Finance, Quality & Compliance and Technical Regulatory, located in Basel, Switzerland.

MAJOR RESPONSIBLITIES 
• As a contributing member of numerous leadership teams, provide business partner support to South San Francisco based Technical Regulatory and Quality & Compliance leaders and their respective global leadership teams. 
• Partner with RQC leadership to understand and seek new business drivers and key operational issues; actively identify tactical and strategic opportunities; contribute to the development of appropriate financial and performance metrics; recommend decision frameworks and present to senior management.
• Lead RQC global functions’ planning and forecasting exercises.
• Provide accurate and timely monthly management reporting.
• Provide decision-support analysis to management on projects and initiatives.  Leverage technical financial knowledge and available data to ensure analyses are well founded and thorough.
• Develop logic, models and presentation material for demonstrating/communicating value proposition for services provided by Regulatory, Quality & Compliance evaluating business need and significant changes within PT and Roche.
• Work closely with Accounting and Global FMT resources to ensure that RQC global functions’ financial and accounting data are accurate and aligned with principles governing technical operations including GAAP and IFRS (FGAR).
• Work with Capital Planning to ensure RQC needs are communicated and included in the Capital budget, forecast and business plan exercises.

...

Finance Manager, FP&A

Reporting to the Associate Director, FP&A, the Finance Manager will support the corporate planning processes, including forecast, budget, and long-term planning.  This position will be responsible for both delivering forecasts/budgets to local management as well as submission of the plans to Basel.  This role will require significant interface with other finance and planning groups across the organization.

Job Description:

• Manage and coordinate planning exercises to meet corporate reporting schedules and goals
• Review and analyze planning data and develop presentations for senior management review
• Act as the primary liaison with Basel (Global HQ) and functional finance teams (at South San Francisco) for all planning-related issues
• Lead ad hoc analyses as assigned to support senior management strategy discussions and decisions
• Proactively identify, design, and implement enhancements to existing planning processes and systems 

...

Position requires an experienced Human Capital Management (HCM) Technical Analyst with demonstrated work experience on multiple project and support environments.  This role will require ability to manage complex solutions in a high-pressure, fast-paced environment in close coordination with the customer.  Excellent customer orientation is critical to the role because position is face to the customer.   

Specific responsibilities include: 

• Heavy focus on end user support; Consulting related to HR system functionalities
• Collaborate with business users, end users, system architects, developers, vendors, and engineers on system solutions.  
• Day to day system administration, application monitoring and proactive issue resolution
• Analyzing and resolving IT Incident in co-ordination with Shared Service Centers (SCC) and IT partners.
• Managing standard pre-approved change requests.  Change requests will require system configuration or coordination with solution delivery team. 
• Refresher trainings (focus on usage of current functionality)
• Creating and maintaining knowledge management in close collaboration with local IT Service Desks and Employee Resource Center (HR).

...

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.

...

This role provides technical and business leadership to IT and our internal business partners; its primary focus is developing and improving business processes. The individual acts as a business relationship manager responsible for the collection, analysis, review, documentation, and communication of business requirements and needs. The individual also acts as a liaison between IT and business units or vendors, establishing relationships with employees and key stakeholders. The individual is responsible for designing solutions with architecture, engineering, and various IT entities. The role also assists with the development of metrics, both within the technology and business organizations. The solutions must be developed at the best possible cost and aligned with customer and business needs. The individual oversees the development and implementation of corporate standards, technology architecture, technology evaluation, and life cycle. To be successful, the individual must possess a combination of business, technical, and leadership skills. This requires an understanding of customers’ business needs, processes, and functions.  They also need a solid knowledge of IT infrastructure, architecture, applications development, and support. In addition they must possess excellent communication skills and the ability to influence others. They must be able to quickly assess the impact of technical issues on the business and make decisions appropriately

...

Sr. Finance Manager – Pharma Finance Development (PFD), South San Francisco

Description:

The Pharma Finance Development group has ~ 45 people in multiple locations around the globe.  It is a cross-functional, cross-cultural group that supports the Roche Product Development organization.  This role is based in South San Francisco and reports directly to the Director of SSF Pharma Finance Development. 

The Senior Finance Manager is responsible for providing financial management and decision support to the Product Development organization. 

Major Responsibilities:
•   Provide local financial controlling support to several functions within Product Development (Biometrics, Portfolio Management, Global Medical Affairs, Quality)
•   Provide global controlling support in collaboration with global functional controller for Biometrics
•   Act as internal consultant by providing financial consultation and guidance to business partners as needed;  support business in understanding state of finances and actions required to achieve business objectives
•   Provide support for all budgets & forecasts for respective local and global functions supported throughout the year
•   Prepare and present monthly financial results to functional leadership
•   Participate and drive key strategic projects for PFD in support of Product Development
      o Provide strategic financial analytical support that both measures and drives efficiencies within the Development organization and improves decision making
      o Present analysis to PFDLT and the PDLT sub-functions
•   Collaborate with Global Controllers, Life Cycle Controllers and Global Development Heads on cross-functional projects and to ensure Product Developments meets its business objectives

...

Weare seeking one or more seasoned and dynamic thought leaders in oncologytranslational sciences / medicine to join the Oncology Biomarker Development(OBD) group at Genentech.

The AD/D of predictive diagnostics will provideexceptional scientific and strategic leadership for therapeutic franchises and/ or disease-based biomarker activities in support of a large number ofoncology molecules in late-stage clinical development and/or FDA-approved.

Leading a team of lab-enabled scientists / Sr. scientists, the incumbent willbe responsible for development and oversight of the Franchise biomarkerstrategies and ensuring successful execution of drug-diagnostic co-developmentin collaboration with the Companion Diagnostics Development group within OBD.

The successful candidate may also serve as a Biomarker Subteam leader for oneor more molecules within their Franchise area. This role requires an individualwith outstanding communication and leadership skills, as well as the ability tobuild strong relationships with key stakeholders in product development andother relevant functions and navigate challenging situations.

The individualmust also be viewed as a strong scientific and strategic leader, one who canreadily bridge between a cutting edge Research environment and a fast-pacedclinical and product development organization. The successful candidate isexpected to drive the publication of biomarker data in high quality scientific,technical or medical journals, to represent the department and programs at externalmeetings, to be a key representative to our investigators, and to promotecollaborative efforts to forward the biomarker sciences field in general. Thisis an important leadership role with substantial visibility within Genentech /Roche organization.

 

As an AD/D, you areexpected to:

• Provideexceptional scientific leadership across multiple molecule teams, to your peerswithin OBD and to the organization in general with a particular focus on latestage development
• Provideleadership, visibility and expertise to the oncology product developmentorganization on all biomarker related question for a specific therapeuticfranchise
• Leadbiomarker strategies at a franchise level, and lead one or more biomarkersubteams
• Representbiomarker related strategies and plans to late stage development review forums,decision committees and project teams.
• Leadbiomarker related regulatory strategies and interactions with healthauthorities around the globe including review of relevant regulatory documents
• Bean active member of the OBD Leadership Team, contributing to the continuingstrategic development of our Department and our people
• Leadand drive scientific and technical innovation collaboratively with othermembers of the Department
• Drivehigh quality publications in high impact scientific, technical or medicaljournals
• RepresentOBD externally through presentations at key National / International meetings,interactions with our key investigators
• Participateand thrive in an interactive, team oriented culture

...

The Department is currently seeking an additional Pathologist to work with five of its Pathologists to help them support (i) research scientists who discover and develop drugs for the treatment of cancer, and (ii) research scientists and clinicians who discover and develop biomarkers for pharmacodynamics and patient selection purposes in Phase I, II and III clinical trials of oncology therapeutics.

The successful candidate will be familiar with, if not expert in, the molecular, cellular, systems biology, and pathogenic mechanisms of cancer. He/she will have a strong interest in providing pathology support for drug and biomarker discovery programs in cancer, and an appreciation for the need for potential flexibility in contributing support to programs outside of oncology as the need arises.  Depending on the candidate and the availability of resources, there may be an opportunity for the individual to spend part of his or her efforts in basic and/or translational research activities that have relevance to the company’s business goals.

...

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.

 

 

 

 

 

 

 

 

...

Job Description (gRED ECD Onc Clinical Science Specialist [E4a])

Genentech is seeking a Clinical Science Specialist (CSS) with clinical and drug development experience in oncology to join the Genentech Research and Early Clinical Development (gRED) Oncology ECD organization and support Clinical Science deliverables for clinical trials and programs associated with the exploratory clinical development of novel anti-cancer agents within the Genentech portfolio. These programs span first-in-human Phase I studies through proof-of-concept Phase II studies in a variety of malignant disorders, and may involve collaborations with other Clinical Development teams at Genentech, corporate development partners, and external scientific/academic/clinical organizations. The optimal candidate will have the desire to proactively participate within a multi-disciplinary team of internal clinical and commercial colleagues and have the ability to interact with external experts and investigators.

Job Duties and Responsibilities:

Scientific Writing

• Draft Strategic Context Documents (SCD), Clinical Protocols, and Investigator Brochures, and coordinate the successful completion of documents with medical editing.
• Conduct literature searches, draft abstracts, draft safety narratives, draft background sections of clinical documents, and ensure that standardized disease/molecule protocol language is incorporated (e.g., eligibility, dose-modification criteria, risk language, key scientific statements). Track items for inclusion in protocols and ICF amendments and work with Medical Editing to ensure the completion of the protocol and any subsequent amendments.

Functional Activities

• Serve as a Clinical Science representative on cross-functional teams as assigned (i.e., Protocol Execution Team, Safety Sub-Team, Biomarker Sub-Team, cross-functional initiatives).
• Identify and implement processes to share clinical information across teams/molecules/indications.
• Develop study-specific listings with data management representatives and conduct frequent clinical data listing reviews.
• Working closely with the gRED medical monitor, serve as primary point of contact for, and triage, clinical study inquiries from site staff, CROs and site monitors regarding the study protocol, modifications to informed consent, and patient-specific questions. .
• Partner with Data Management for CRF design, instructions for unique CRFs, and data quality plan.
• In conjunction with a Medical Director, create and or review clinical slides for internal and external meetings (i.e. Investigator meetings, PSSV and SIVs, Study Coordinator and CRA training, Advisory Boards, scientific meetings). Develop and QC data tables with biostatisticians to support these activities.
• Participate in tracking/analysis of any potential safety events within a given trial and across trials for assigned program(s).
• In conjunction with Biostats and Medical Director review appropriate analysis and reporting documents (i.e. clinical study report, analysis plan, etc.).
• As assigned, participate in development of the long-range strategic plans for the assigned program(s).
• As assigned, participate in Clinical Science assessment of in-licensing opportunities.
• As assigned, mentor and/or train new Clinical Science Specialists

...

Location:  San Francisco

The Procurement Manager is a vital role within the Pharma Procurement organization charged with building and maintaining a strong partnership with internal stakeholders. It is a leadership role in the development and execution of procurement strategies to maximize the value of the services procured for the US organization. This role is also responsible for Supplier Relationship Management, Process management and Customer relationship management.   This role is responsible for developing and demonstrating in-depth knowledge of markets, suppliers, products and their cost drivers within this category.  In addition, this role will be responsible for supplier relationship management and will lead cross-functional teams through strategic category sourcing to deliver breakthrough business benefits.

Key Responsibilities:

• Execute and implement professional services sourcing strategies for various Commercial groups. This position will require in-depth industry expertise in one or more of the following categories of spend: consulting firms, market research companies, training and meeting logistics vendors. 

• Demonstrate consultative behaviors with stakeholders so that this is the Procurement SPOC for the stakeholder

• Collaborate with stakeholders and key business units/partners to understand current procurement practices and use change management techniques to bring best procurement practices to the commercial groups  

• Provides end-to-end strategic solutions, from idea generation to presentation to senior business management and initiative execution

• Develop and maintain strategic relationships with key suppliers to ensure best service and commercial terms,  continuous improvement, innovation and optimal value are delivered to our commercial groups

• Achieve Annual Value Improvements through: 

o Tracking, monitoring and measuring key performance indicators for Supplier Relationship Management Programs

o Identifying opportunities that focus on cost reductions, efficiencies/quality improvements, risk mitigation, industry and supply trends and shifts in technology

o Driving best practices and reductions in Total Cost of Ownership (TCO)

• Enhance and improve the tools and processes by capturing, sharing and evaluating best practices and lessons learned with Process Leadership

• Facilitate issues resolution when necessary

• Focus on the needs of the US organization while supporting the growth, demands and unique needs for our global organization

• Must be able to succeed in a non-mandated procurement environment 

• Must be able to lead in a cross-functional “matrixed” environment and proactively support internal customer requests

• Act as an ambassador for Commercial Procurement by demonstrating a collaborative and professional style

...

The Genentech Research and Early Development (gRED) Clinical Trial Manager (CTM) provides support and/or leadership to one or more global Study Teams within an early development program(s). The CTM is accountable for activities ensuring high quality deliverables are within budget and timelines.  

 

Primary Accountabilities and Responsibilities:

 

• Support cross-functional Study Team within Clinical Operations with minimal oversight from the Sr. CTM and/or CPL

• Responsible for Clinical Operations deliverables to achieve study objectives and milestones within timelines and budget

• Responsible for vendor selection and management including CRO, IVRS, central lab and imaging vendor

• Provide input to the study budget and is responsible for managing assigned vendor budget(s)

• Under the leadership of the Sr. CTM, takes responsibility for agreed operational aspects (e.g., vendor management, drug supply management)

• Identify and track timelines, milestones, critical study activities, issues and budget and provide regular updates to the Study Team and CPL as appropriate

• Partner with CPL to develop and/or present at project teams and management review bodies

• Conduct protocol and site feasibility assessments

• Provide support, mentoring, and study-specific training to Clinical Operations staff

• Network and share best practices with colleagues to ensure optimal efficiency and consistency in Clinical Operations

• Participate in initiatives and/or activities as assigned

 

Responsibilities and Accountabilities When Leading a Study:

 

Depending on skill level and study design, CTM may lead Study Team, including obtaining agreement on project timelines, study objectives and goals.

 

• Ensure relevant functional groups provide input to and participate in developing and finalizing Study Team level documents and meet Study Team level deliverables within timelines

• Accountable for Clinical Operations deliverables to achieve study objectives and milestones within timelines and budgets

• Provide input to the program budget and is accountable for managing overall study budget

• Delegate and oversee study activities assigned to Clinical Operations Study Team as applicable

• Provide drug supply assumptions to clinical planning team

 

 

These statements are not intended to be an exhaustive list of all responsibilities, duties, and skills required of people assigned to this job, but are instead intended to describe the general nature and level of the work. Different levels of responsibilities and accountabilities may be assigned to take account of the skills capabilities and experience of the individual.

...

• 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.

...

Requirements:

• Provide statistical expertise to multiple nonclinical areas, including projects in research, preclinical studies, assay development, bioprocess development, quality control, and manufacturing.
• Propose experimental design and analysis strategies, perform statistical analyses, and collaborate with investigators to ensure the statistical integrity of nonclinical reports.
• Support regulatory submissions and investigations.
• Build strategic partnerships with collaborators and promote statistical thinking in decision making in nonclinical areas of drug development.
• Provide advice and training on the use of statistical methods and software packages to nonclinical investigators within the company.
• Develop and deliver statistics courses to nonclinical audiences
  Collaborate with scientists in support of external publications.
• Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and professional activities.

...

We are seeking a postdoctoral fellow to work in the laboratory of Dr. Eric Brown. The incumbent will conduct original and significant basic investigations in the area of the pathogenesis of infectious diseases and host response to infection. The expectation is that this work will result in novel and important contributions to understanding of host-pathogen interactions, as evidenced by publication in top tier scientific journals. The laboratory explores both host and pathogen genetics as its approach to understanding the host-pathogen interface and uses a wide variety of genetic, cell biologic, and biochemical methods to investigate these questions. Projects in the Brown lab currently focus on molecular mechanisms and pathologic consequences of Type VII secretion and on regulation of autophagy by ubiquilins....

Summary:    

 

This position serves as an important conduit within the broader organization to ensure a culture of compliance through well-thought out, actionable, aligned and achievable compliance related processes. Given the nature of the group's work, incumbent will communicate and interface with a host of internal cross-functional partners, both within gRED and other Roche functions; identifying key performance indicators, areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance. The Quality Specialist will actively contribute to the development and implementation of Standard Operating Process / Procedures, tools, and templates for application in clinical research and provide and interpretative guidance of such within Clinical Operations and the broader gRED community. 

This is achieved through:

• Proactively identify and manage changes in controlled processes and procedures as the organization evolves, industry practices change and/or regulations change to assure high quality standards with applicable laws, regulations, guidelines and Roche policies.  

• Working collaboratively with all internal and external business partners and key stakeholders to assess clinical business systems and processes and provide input on any unique business requirements utilizing strong interpersonal, influencing, and negotiating skills.

• Identifying and anticipating potential problems impacting the ability to meet business goals; developing and implementing methods of improvement and resolution in a pragmatic and effective manner.

• Staying abreast of relevant laws and regulations that affect organizational quality and ability to remain in a state of regulatory compliance 

• Proactively communicating and educating others regarding such laws and regulations

Key Responsibilities:

• Partner with other departments interacting with Global & Regional functions including, but not limited to: Drug Safety, Quality Assurance/ Risk Management, PD Clinical Operations, Healthcare Law, Corporate Group & Risk Advisory, Medical Affairs to ensure appropriate cross-functional SOPs, Policies or Work Instructions are in place. 

• Facilitate SME involvement and partner with global and cross functional teams in the development, review and implementation new/updated controlled documents (Policy/SOP)

• Serve as a key contact for communicating controlled document and policy changes within/across the gRED organization 

• Provide direction, and guidance to study teams to address quality issues, concerns and or potential regulatory compliance risks       

• Participate in the development and execution of GCP, SOP or Policy related training 

• Provide support and guidance during and following internal audits and external regulatory inspections (as required).

• Provide consultative guidance on business initiatives involving new systems, processes, procedures, regulations and innovative tools for use in clinical research activities.

• Facilitate the process of continuous process improvement and support internal and global cross functional initiatives by analyzing “to be” processes; forms, templates and related process documents to ensure alignment, accuracy, and adherence to relevant internal/country/local legal and regulatory requirements.

 

• Liaise with internal stakeholders and global quality partners to ensure strategic quality risk assessments are completed and provide oversight to gRED management and personnel on contracted service providers to ensure services meet business needs (quality deliverables and alignment to regulatory requirements)

• In partnership PD Quality, identify, interpret, and disseminate quality and compliance related trends, expectations and compliance requirements to leadership and respective governance bodies. 

• Challenge inefficient processes and leverage compliance and maintain highest levels of awareness, expertise in international GxP regulatory requirements, and project-specific procedures applicable to the clinical trial methodology

• Serve as consultant to management and internal/external spokesperson for the organization on matters pertaining to its policies, quality plans, objectives and business goals

• Provide regular u...

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.

 

 

 

 

 

 

 

 

...