The Department of Small MoleculePharmaceutics in Genentech Research and Early Development is seeking a highlymotivated Senior Scientific Manager to lead an effort in pharmaceuticalprofiling and development, during preclinical and early clinical assessment, ofnovel small molecule therapeutics for unmet medical needs. The successfulcandidate will head a small group of scientists, and is expected to:

• Provide exceptional scientific leadership within Small Molecule Pharmaceutics, as well as to other functions, subteams and teams at Genentech

• Develop and effectively manage a small laboratory group focusing on selection, profiling and advancing small molecule clinical candidates in a scientifically rigorous, phase-appropriate manner 

• Drive scientific and technical innovation collaboratively with other members of the Department

• Develop and execute preformulation and formulation strategies based on strong scientific rationale and pharmaceutical/biopharmaceutical properties of the molecule for one or more projects

• Author development reports and relevant CMC sections for regulatory filings

• Publish in high quality scientific and pharmaceutical journals

• Participate and thrive in an interactive, team oriented culture, interfacing with discovery and early development functions

We are seeking an outstanding individual for theposition of a Research Associate / Senior Research Associate within theBiochemical and Cellular Pharmacology department. The successful candidate willbe responsible for supporting research projects in the disease therapeuticareas of immunology and/or immunotherapy as part of the biologics drugdiscovery program at our South San Francisco campus. The individual will be expectedto work independently in developing and performing immunochemical, biochemical,and cell-based assays to support candidate selection, potency, efficacy, andpharmacokinetic studies as well as immunogenicity evaluation andpharmacodynamic biomarker measurements. In addition, the individual will incorporateautomation into his/her daily work and apply novel technologies in assaydevelopment.

How do changes in genome sequence affect biological function and disease? We cannot assay billions of mutations, but evolution has already tested the impact of changing every base in our genomes. Comparative genomics now offers a key to break this ‘evogenetic code’ by exploring which mutations survived evolution and how they correlate with the rest of the genome and on the biology of the organism.

We are looking for a smart, skilled, and highly motivated postdoctoral fellow to lead our exploration of genome evolution by reconstructing ancient genome sequences and modeling mutation patterns and evolutionary constraints. This will have potentially profound implications on understanding human sequence variation (familial and somatic), on understanding protein functions, and on relating genomics to organismal biology.

Our postdoc training encourages exposure to multiple projects, and we also have remarkable opportunities in the integrated analysis of cancer genomes. The Department of Bioinformatics and Computational Biology at Genentech is one of the largest bioinformatics research groups with a remarkable breadth and depth of expertise, a strong team environment, deep links to our research colleagues, and a uniquely strong opportunity to help develop breakthrough new medicines. The Manning lab (http://manninglab.org/) focuses on understanding of biological function and disease through evolutionary genomics analysis.

Summary of Position:

The Compliance & Training associate reports directly to the Manager, Compliance & Training. This individual will work closely with the US Drug Safety staff to support all safety-related activities accountable to US Drug Safety.  In addition, interactions US Medical Affairs Compliance will also occur on an as-needed basis. 

Job Duties/Responsibilities:

• Training of vendors and other 3rd parties to drug safety reporting requirements
• Working with commercial organization to ensure monitoring of Genentech sponsored websites for adverse event reporting
• Oversight of US Drug Safety audit and inspection findings and CAPAs
• Oversight of US Drug Safety local procedures and controlled documents
• Management of US Pharmacovigilance & Safety Data Exchange agreements 
• Management of US Drug Safety global pharmacovigilance commitments
• Monitor IT issues
• Management of special projects
• Track US pharmacovigilance metrics
• Conduct vendor assessments for AE reporting compliance
• Interact, where applicable, with US Medical Affairs Compliance to address safety-related issues or concerns

Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :

·         Works with a host of internal and external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication

·         Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries

·         Participates in the identification of appropriate external investigators

·         Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications

·         Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.

·         Supports his/her manager in developing clinical components of presentations* for clinical trial investigator meetings

·         In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors

·         Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager

·         Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.

·         Keeps all partners abreast of projects progress throughout all applicable intervals

·         May also participate/coordinate collaborations with external stakeholders

(e.g. cooperative groups, other companies, etc.) on development and implementation of

approved clinical projects.

·         May coordinate, liaise with internal and external providers for data mining activities

·         Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.

·         May interact with NCI or other agency, as appropriate, with supervision from his/her manager

¿ Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature

Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of production equipment within the PTD Operations and Engineering group.  Assist with engineering and evaluation of existing and new equipment and processes.

Responsibilities:
• Responsible for the maintenance and repair of all mechanical process equipment within PTD Operations & Engineering at the South San Francisco facility
• Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
• Conduct routine inspections and monitoring of equipment and systems.
• Perform troubleshooting of electrical, pneumatic, and mechanical equipment.
• Complete preventive maintenance and assigned paperwork in a timely manner.
• Assist/Manage specialized maintenance and equipment projects as needed.
• Responsible for inputting data to derive performance metrics for management
• Coordinate contractors and work in conjunction with internal business units who perform repairs, modifications, preventive maintenance and installations of mechanical and electrical equipment.
• Provide technical expertise and training to junior staff.
• Assist as a technical SME with identification, purchase, and organization of spare parts.
• Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on production equipment.
• Ensure/maintain all process equipment and areas in a constant state of inspection readiness; specifically, but not limited to, the following:
o Cleanliness
o Personnel and equipment safety.
o Area maintained in an organized fashion.
• Continuously evaluate all operational Standard Operating Procedures and Preventive Maintenance procedures for accuracy and applicability.  Submit appropriate change requests to supervisor to correct any deficiencies discovered. Create new SOPs and equipment/system related procedures.
• Interact with PTD Operations and Engineering staff members as well as other internal/external customers.
• Follow established safety and environmental guidelines and procedures for all work performed. Immediately report safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Foster a positive safety culture.
• Respond to emergency call-in when regular scheduled personnel are not available

• Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
• Conduct routine inspections and monitoring of equipment and systems and documenting systems operating parameters.
• Make appropriate adjustments or modifications within company and GMP guidelines and notify supervisor of any abnormal parameters.
• Lead and organize specialized maintenance and equipment projects. Includes research of methods and devices, assisting with implementation and documentation of change control.
• Provide general labor services throughout all areas maintained by the Maintenance department.
• Responsible for providing data to derive performance metrics for management that will be gathered on a daily basis for monthly reporting.
• Provide technical expertise and training to junior staff.
• Assist as technical SME with identification, purchase, and organization of spare parts.
• Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on manufacturing and utilities equipment.
• Cleaning and organization of designated work areas in Manufacturing and Utilities.
• Complete GMP and other controlled documentation.
• Revise or modify existing SOP documentation as necessary and be expected to write new procedures for new equipment and other duties as assigned by management.
• Interact with Manufacturing, Instrumentation, Metrology and Engineering staff members as well as other internal/external customers.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

Objectives and Scope of Position:

• Responsible for the preparation of regulatory documents for submission to regulatory authorities within subject area (clinical/safety). This role involves working in close partnership with the medical/scientific content owners in the relevant functions
• Takes accountability for delivering regulatory documents and works effectively and closely with key content owners 
• Applies document and project management expertise
• Contributes to the functional excellence of regulatory documentation (process management) 

Primary Responsibilities and Accountabilities

• Prepare regulatory documents in accordance with applicable regulatory guidelines/Roche standards/SOPs, ensuring high scientific quality & consistency with other documents where appropriate
• Liaise with document contributors to gather information (including Licensing partners where relevant)
• Plan & create timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate
• Review documents for: organisation/clarity/use of English language/grammar/scientific standards/consistency between textual presentations and listings/tabular or graphical displays 
• Manage the review process, including leading/coordinating adjudication of review comments and incorporating review comments
• Participate as a member of key functional/cross functional Team (s) (e.g. Regulatory Area Functional Team, Safety Team etc), ensuring that Teams adequately plan for document deliverables
• Ensure that the document is published in collaboration with Regulatory Operations and that the document is approved by the single accountable signatory

In addition as a Senior Regulatory Documentation Scientist

• Manage the preparation of a suite of regulatory documents e.g. Clinical Dossier, suite of Safety Documents
• Lead Writing Team for preparation of Clinical Dossiers/Safety Reports
• Review documents to ensure adherence to documentation quality standard, regulatory requirements and consistency of messages across all documents for a product/across clinical documents within a dossier
• Prepare specifications for outsourced work (writing/review of documents) and serves as Roche liaison for project purposes
• Plans and creates timelines for the production of assigned documents e.g. Clinical Dossier/Suite of Safety documents. Ensures proper planning and resourcing of all documents assigned to Writing Team including what work or portions of work to be outsourced
• Actively contributes to best practices and continuous improvement within Regulatory Documentation. Represents the group in functional and cross functional initiatives/projects when required

S3

Who we are

At the RocheGroup, about 80,000 people across 150 countries are pushing back the frontiersof healthcare. Working together, we've become one of the world's leadingresearch-focused healthcare groups. A member of the Roche Group, Genentech hasbeen at the forefront of the biotechnology industry for more than 30 years, usinghuman genetic information to develop novel medicines for serious andlife-threatening diseases. The headquarters for Roche pharmaceutical operationsin the United States, Genentech has multiple therapies on the market for cancerand other serious illnesses. Please take this opportunity to learn aboutGenentech, where we believe that our employees are our most important asset andare dedicated to remaining a great place to work.

The Position

The successful candidate will participate in cross-functionalproject teams discovering antibodies with high therapeutic potential to addressmajor unmet medical needs across different therapeutic areas.  This hire will lead a group discoveringantibodies from immunized sources. Research by this group will included enhancing understanding andoptimizing the immune response in immunized mice plus isolation and culturingof antigen-specific B cells.  Thisindividual is expected to collaborate closely with colleagues in other antibodydiscovery groups and other departments.

Act as the main point of contact between Solution Owners, Project Managers and the Operations Support team in the release or implementation of new services, applications or products into production. Ensures smooth transition of new Operational Services and provides implementation support for the Regions

• Ensures tools, processes and procedures are in place to enable the Regions to support new services, applications and products
• Coordinates with the AE&O Support Processes & Continuous Improvement team and the Regional Account Managers on the release and design of new services, applications and products into production 
• Develops methods to track and monitor the Service Health and provide initial reporting
• Acts as the main point of reference and is consulted in Operational AE&O IT projects that impact the tools, processes and technologies used in the Operational Teams in the support of AE&O provided services
• Develops Training material for new Services in collaboration with the solution owner and coordinates the Trainings with the Regional Account Managers
• Assists the Site Implementation Team during the integration of new sites or acquisitions to ensure Processes, Training and Regional/Local Support is in place.   
• Coordinates with the Support Processes & Continuous Improvement Team, the AE&O operational Teams and the Regional Account Managers to ensure tool and Process availability for a upgrade to an existing service, new service release or implementation 
• Ensures and coordinates knowledge base updates with any required information to support a release or implementation
• Ensures Training material availability on new processes and procedures and coordinates Trainings in cooperation with the Regional Account Managers
• Reviews project plans with the Solution Owner or Project Manager for transition planning and provide feedback to ensure a smooth release or implementation.
• Provides reports and monitoring on the impact of releases and implementations on the AE&O operational Teams and the Regional and Local support teams and drives improvements until normal operations are achieved
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• Works with Solution Owners and Project Managers to ensure that requirements of the Operational Teams and the Regional/Local Support teams are represented and understood
• Ensures efficient processes for Operational and Supporting teams and establish an aligned incident escalation chain to reduce escalations. 
• Push automation opportunities for request and change management, reduce escalation of incidents by enforcing Knowledge management usage and validation of KM data.
• Establish early reporting and Service Health metrics with trending information on incidents, requests and changes. 

The ERP Portfolio and Demand Management Coordinator position provides non-technical support primarily to the North American based ERP (Enterprise Resource Planning) team, within the Shared Platforms and Applications area of Pharma Informatics. The global ERP team consists of approximately 180 team members, 50 of which are based in our SSF office. The ERP team mainly supports the business application areas of SAP, Business Warehouse and ARIBA.

This SSF-based position is within the ERP Portfolio and Demand Management team. The ERP Portfolio and Demand Management team is responsible for many important cross-functional topics, such as financial management, demand planning and communication, supporting and advising project managers, process implementation and compliance, audit co-ordination and tracking, metrics and reporting, as well as adhoc management support requests. We support the various managers, project managers and application teams to ensure consistency and efficiency across the ERP Department. 

As part of this small team, you will have a varied and challenging role, working on cross-functional topics while interacting with team members in Basel as well as colleagues other functions (e.g. Finance, Procurement, HR).

You will have the following key responsibilities:

• Support the required financial processes, including the coordination of the budget and monthly outlook events and monitor the budget versus actual spend. Proactively support and advise the SSF based activity owners and project managers on financial topics
• Provide the required financial reports and updates, accurate and timely organizational information and recommendations to ensure the ERP department stays within the given budget
• Support the ERP Team, being the point of contact and advisor for the North American based ERP team with day to day business processes to ensure efficiency and accurate information flow (e.g. purchase order creation and processing, payment of invoices, checking accuracy of accruals, etc.). Advise team members in order to resolve issues in a timely way.
• Manage key relationships and liaise with other departments as required, e.g. Finance, Procurement, HR.
• Support the ERP Team with the needed tools and processes to manage the ERP portfolio of work, which will enable the ERP department to meet the needs of their customers.
• Participate in or lead small projects/initiatives as needed to ensure implementation of common process and tools (e.g. Resource management, Customer satisfaction surveys) and provide ongoing support to the ERP Department
• Assist the Portfolio and Demand Management team establish and report on metrics required by the ERP Solution Owners
• Support and assist with the ongoing improvement of Collaboration tools, such as Touchpoint.

Job Title: Senior Specialist (E4/5)

Job Responsibilities:

·         Key contributor for developing consistent strategies for stability studies performed at different sites, CMOs and partners

·         Manage and monitor milestones and detail timelines for assigned commercial products to ensure the achievement of corporate goals and objectives while providing timely and transparent communication to the PMT subteams and other cross-functional teams.

·         Provide scientific rational for stability study design and propose changes for the Genentech Quality organization

·         Provide scientific and technical leadership in Inspection/ Audit situations, thinking critically and acting creatively while providing information quickly and accurately

·         Author and  provide scientific as well as technical representation of Stability in all stability relevant sections for Submissions, Regulatory Agency responses, APRs and ARs

·         Work closely with other Senior Specialists and senior management to develop strategy for long range operational and resource planning   

·         Serve as a subject matter expert (SME) for stability questions related to assigned commercial products

Associate Group Manager, Government Calculations

The Associate Group Manager, Government Calculations leads and oversees the function and specialist team of calculations managers who process all Government Pricing & Reporting (GP)-related calculations and are accountable for compliance with strict accuracy targets, timelines, laws, regulations, government contracts and GP’s methodology. In addition, the Associate Group Manager is responsible for effective deployment of and improvements to GP Standard Operating Procedures (SOPs), systems, technologies, and data. The Associate Group Manager regularly engages with relevant partners and stakeholders to resolve operational issues. He/she may also lead cross-functional projects from a GP calculations, systems, process or data perspective.

• Acts as the subject matter expert for content and interpretation of various, often complex, government programs, contract strategies, contract issues or terms, e.g. pricing and payment calculations, contract performance, compliance, etc.
• Proactively reviews and assesses existing government programs, contracts, contract administration practices, policies, guidelines, systems, performance tools, etc. versus new, extended or enhanced opportunities. Plays a leadership role in recommending new opportunities; including leading in the development and implementation of such
• In conjunction with Managed Care Contracts Manager, collaborates with the renewal of Federal Supply Schedule Contract
•  Plays a leadership role in GP-wide annual and longer-range strategic and tactical planning
• Leads Government Calculations input into GP annual and longer-range strategic and tactical plans. Includes developing and recommending budget requirements for the work of Government Calculations
• Coordinates with Government Analytics & Compliance on stakeholder meetings and planning initiatives. Provides expert recommendations and perspective to ensure, from the government contracting process and calculations perspectives, effective and efficient policies and contracting strategies
• Develops and cultivates professional relationships internally and externally; including external vendor partners supporting or otherwise involved in work relevant to Government Calculations
• Works with Legal, Government Analytics & Compliance and other groups to evaluate legal and regulatory requirements with government payer pricing and contracting strategies to ensure full and exacting alignment and compliance for Genentech; including all relevant government contracting and calculations processes, monitoring and reporting practices, systems, data and other tools
•  Supports as needed, or otherwise participates in the development of new, enhanced or extended government pricing and contracting strategies
• May present pricing certification decks to senior executives
• Leads development, education, communication, implementation and ongoing maintenance of Government Calculations SOPs, systems, data, reporting templates, and the like. Accountable for development and maintenance of effective GP systems and data
• Plays leadership role in development of performance metrics for monitoring, evaluation and reporting of government payer contracts and programs
• Collaborates with Government Analytics & Compliance to create GP-wide training
• Manages development and implementation of Government Calculations-specific training and ensures team members are provided such training in a timely and thorough manner
•  Leads GP project initiatives specific to GP operations
•  Leads department and team to ensure the highest levels of performance for government contracting processes and price calculations, to include maximum efficiencies and compliance:
•  Manages team to ensure accurate and timely completion of pricing calculations  according to the varying legislation, regulations and terms of contracts for government payers and programs
•  Responsible to ensure ongoing and consistent adherence to all applicable laws, regulations, corporate and business unit standards and requirements 
•  Reviews and approves pricing calculations from team members. Ensures pricing calculations are provided to other Government Pricing & Reporting partners to ensure timely and accurate processing
•  Regularly monitors compliance to internal and external policies
•  Manages any issue resolution 
•  Responds to questions from team members and other partners/stakeholders regarding complex issues that may require interpretation
•  Ensures team prepares and delivers routine and ad hoc reporting, as per departmental guidelines, standardized work practices, or otherwise as needed
• Self and team participate in internal and external auditing; including...

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.

The Senior Scientist, in vivo pharmacology, will lead a translational research group focused on immune-mediated oncology therapeutics. The successful candidate will work closely with other disciplines within Genentech to drive research stage programs into early clinical development, providing scientific and strategic leadership, and technical management. The individual must be motivated to work in a scientifically rigorous, fast-paced environment to achieve key results that drive program decision-making. The ideal candidate will have an in-depth understanding of immunology, cancer biology and animal models with a strong publication record.

Summary of Key Responsibilities:

• Lead translational research group primarily supporting tumor immunotherapy programs.
• Develop experimental strategies to define/validate the mechanism of action and mechanism of resistance of immune-mediated anti-tumor therapeutics.
• Provide in vivo pharmacology expertise to project teams during the discovery and development phases of biologics and small molecule drug discovery programs.
• Define PK/PD/efficacy relationships in collaboration with colleagues within DMPK and research oncology.
• Develop innovative preclinical animal models that enable interrogation of mechanisms of action, diagnostic hypotheses, and mechanisms of resistance.
• Direct management of up to 5 research associates, in vivo and in vitro. Develop and assess goals of direct reports.
• Responsible for authoring documents to support regulatory filings and patent applications.