Position is responsible for the development, maintenance and advancement of the Enterprise Resource Planning (ERP) system recipes and master data used by SSF Clinical Supplies Management.  Successful candidates will represent the department as a subject matter expert and liaison between a variety of key internal and external stakeholders.  They will lead processes to ensure successful SAP data development, deployment, and maintenance and will ensure appropriate integration of CLARA, R3, and APO with supporting systems.  The successful candidate will be adept at leading cross-functional teams in problem identification and resolution.  They will be relied upon to work collaboratively and independently to solve emerging challenges inherent to rolling out new data applications.  The position will provide support of user needs for current and future applications for the Clinical Supplies Management department.  They will represent the department in interactions with the global business process management community and will proactively identify areas for improvement.  Additionally, the successful candidate will play an important collaborative role in the integration of the newly formed production services team.  To this end, the successful candidate must also demonstrate competency and/or aptitude as well as interest in broader aspects of materials management, master production scheduling, capacity management, and detailed scheduling.  In addition to their system expertise, they will bring a willingness to learn new skills and tasks that will allow them to successfully backfill other production services roles in a dynamic environment.

Job Responsibilities

Scope of Work - The Business Analysts will be responsible for creating the SAP Recipe in collaboration with data owners to enable materials and capacity requirements planning and successful execution. Responsibilities of this position include:

*Develop SAP recipes for load into system
*Coordinate and lead data strategy and execution meetings with site and network representatives
*Provide technical solutions to a variety of problems of moderate scope and complexity.
*Develop solutions that are imaginative, thorough, practicable, and consistent with organization’s objectives
*Adhere to change management processes to ensure data accuracy is maintained across systems
*Provide reporting and analysis required to manage key performance indicators
*Translate business requirements to technical specifications and collaborate with key stakeholders to complete requests
*Provide training on usage, enhancements and changes to business systems
*Work is performed under limited direction and guidance, with general instructions on new assignments
*Proactively recommend priorities, timelines, and resources for addressing emergent business needs
*Participate in developing courses of action that may impact multiple functions in the organization
*Network with senior internal and external personnel in own area of expertise. Represent organization on assigned projects
*Identify opportunities for improvement
*Lead cross functional and cross network teams in the identification and implementation of improvement initiatives

The Senior Corporate Counsel or Assistant General Counsel (Specialist) will work as part of the Healthcare Law Group within Genentech's Legal department. 
The position will have the opportunity to provide legal advice and support across the lifecycle of Genentech's products, including commercial, medical affairs, development and manufacturing functions.  Supported teams include brand sales and marketing teams, commercial strategic and operational functions, and medical affairs and development teams that have human medicines and companion diagnostics in all phases of development, and manufacturing.  Specific activities may include the following:

Provide statistical and strategic support related to clinical development plans, study designs, planning and execution of exploratory biomarker analysis, and incorporation of biomarker objectives in clinical development plans.

Major Responsibilities and Accountabilities:

• As part of a clinical development team, collaborates in the preparation and review of protocol writing, CRF design and monitoring of ongoing clinical trials.
• Provides technical and strategic support into clinical development plans
• For assigned clinical development project(s), provides statistically sound clinical trials design, including clinical pharmacology trials and data analysis input to meet project objectives.
• Supports teams in the development and review of regulatory submissions such as clinical protocols, INDs and pre-meeting packages.
• Provides strategic and analytical support for exploratory project activities such as biomarkers and PK/PD analysis
• Develops statistical analysis plans, including biomarker analysis plans, prepares data displays and as necessary develops statistical programs to perform exploratory analyses.
• Authors the clinical study report; with help from senior statistical staff, leads team members to complete the report.
• Provides advice and training on the use of statistical methods and software packages to the biomarker scientists
• Collaborates with scientists in support of external publications.
• Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, workshop attendance, etc.

The IT Business Systems Analyst position will be responsible for working closely with partners across lines of business and the IT group in order to understand strategic drivers and tactical needs to ensure that implementation teams can provide solutions that meet the business need with the necessary stability, usability, and scalability. The IT Business Systems Analyst will be supporting projects in the global Laboratory Information Management Solutions portfolio for manufacturing and clinical Quality Control laboratories.

Duties:

• Analyzes business scenarios and identifies opportunities for improvement through automation and/or business process change
• Provides analytical expertise in identifying, evaluating, designing and developing systems and procedures that are cost effective and meet user requirements.
• Develops user requirements, functional requirements and/or technical specifications, process flow diagrams; may configure some system settings and/or options.
• Provides consultation to users in the area of business systems and processes.
• Leads cross-functional analytical teams in the resolution of business or systems issues.
• Leads successful completion of major projects/programs across portfolios. 
• Champions accountability by example.
• Applies advanced technical principles, theories, and concepts related to requirements, data, usability and process analysis.

• Other duties as assigned:
• Conducting 1:1 or group interviews, facilitating workshops
• Facilitating and supporting GMP validation, system and user acceptance testing
• Participating in roadmap discussions and vendor assessments
• Overseeing and mentoring less senior resources on solution or project teams
• Overseeing consultant resources as applicable

The Quality Product Leader is part of Clinical (IMP) QA.  This position will be responsible for managing the quality logistics for commercial product used in clinical trials across the network. The job responsibilities include creating and implementing business processes to effectively manage the logistics for small and large molecule active, placebo, and comparators; both product produced by Roche and by a competitor.  The position is global.  This position will establish and maintain strong partnerships with internal and external colleagues, customers, and stake-holders.  These groups are located globally and are comprised of, but not limited to, QA Operations, Commercial Product Quality Stewards, External and Site Quality, Commercial QC, Product Development, Global Supply Chain, Country Qualified Persons and Pharma Technical Regulatory (PTR).

Position

Pharmacovigilance Programmer Analyst

Job Summary/Purpose:

Experienced Oracleprogrammer with good knowledge of Drug Safety databases.

• Assumes responsibility for the analysis of data from the Drug Safety Database (ARISg DataMart).
• Develops, tests, documents, maintains and validates programs written in SQL, PL/SQL and SAS.

Primary Job responsibilities:

The positionis within the Data Management Group (DMG). DMG is responsible for dataretrievals from the Drug Safety database. These retrievals are performed on adatabase named "ARISg DataMart", a databases that gets dailyincremental uploads from the ARISg transactional system. The DataMart isdesigned and optimized for data retrieval.

The maincustomers of DMG are the members of safety Science located in Basel,Switzerland, and San Francisco, CA. DMG performs data retrievals for ad-hocquery requests, aggregate reports and for signal detection. Currently all DMGmembers are located in Basel, Switzerland. The position is created to supportSafety Science on site in San Francisco.

Thefunctional requirements in detail are the following:

• Interactswith internal or external customers to clearly define the search criteriarelating to requests; and to aid in the selection of the appropriate dataanalysis strategy and adequate presentation of results.
• Checksresults of database retrievals for consistency and plausibility. Initiatesappropriate actions in case data inconsistencies are detected.
• Performs thestatistical analysis and presents data in appropriate format i.e., reports,line listings, tabulations or graphs through using a variety of tools like SQL,SAS, Excel.
• Ensurestimely and correct delivery of search results.
• Responsiblefor the documentation of the search strategy and the results (electronically oras hard copies). Ensures search strategies and results of searches are filedand archived.
• Assists inout-of-normal-office-hours ad hoc/special database searches in the event ofurgent enquiries or audits by regulatory authorities.
• Assumesresponsibility for signing validation documentation.
• Ensures anyissues relating to database searches are highlighted to the Head of PDS DataManagement Group.

We seek a highly motivated Scientist / Sr. Scientist to lead biomarker development efforts in support of Genentech’s Oncology pipeline. The incumbent will lead a small laboratory group focusing on predictive and pharmacodynamic biomarker development efforts, as well as lead and support biomarker subteams for programs in clinical development. All of the Scientists in OBD are encouraged to develop a focus in one of several areas that advance our understanding of specific diseases or enable advanced biomarker assessments through exploration of innovative, cutting-edge technologies.  For this particular position, a strong background in cancer cell signaling and cancer genomics, evidenced by peer reviewed publications in top tier journals, is required.  Practical experience with predictive or pharmacodynamic biomarker development in an industry setting would be an important asset.  The successful candidate is expected to effectively lead cross functional teams, to publish innovative biomarker or disease focused research in high quality scientific, technical or medical journals, present to our key investigators and at meetings and promote collaborative efforts to push biomarker sciences forward. Scientists / Sr. Scientists in OBD are expected to be, or develop into, externally recognized leaders in clinical translational sciences.

As a Scientist / Sr. Scientist, you are expected to:

• Provide exceptional scientific leadership within OBD, as well as to other functions, subteams / teams at Genentech / Roche
• Develop and effectively manage a small laboratory group, predominantly focused on scientific support for molecule programs
• Drive scientific and technical innovation collaboratively with other members of the Department
• Lead one or more biomarker subteams
• Develop and execute on lead and exploratory biomarker strategies for one or more projects
• Participate in, or lead, disease focused translational biomarker programs, or develop a key focus on novel technologies that advance clinical biomarker assessment
• Publish in high quality scientific, technical or medical journals
• Represent OBD externally through presentations at key National / International meetings, interactions with our key investigators
• Participate and thrive in an interactive, team oriented culture

(External Quality, Commercial Drug Substance)

Sr. Technical Manager, Tech Transfer – Biologic Drug Substances (SSF)

Main Purpose of the Position: 

* Provide Quality oversight for Roche and Genentech products manufactured at Contract Manufacturing Organizations (CMOs) to ensure compliance with cGMP regulations and Roche/Genentech standards. 

* Serve as the Quality single point of contact for designated CMO(s) and participate as a key member of Drug Substance (DS) CMO governance teams to support site selection, product technical transfers and on-going external commercial site management.

Responsibilities:

* Participate in site selection and product technical transfer activities at CMOs, such as due diligence audits and GMP readiness activities.

* Manage all required activities to support release of commercial product including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls. 

* Develop, negotiate and maintain CMO cGMP quality agreements and ensure compliance with agreements.

* Develop/maintain quality risk management plans; utilize risk management tools to identify and mitigate CMO quality and compliance risks, ensuring CMO sites are in a state of continuous inspection readiness.

* Participate in regulatory inspections and cGMP compliance audits, collaborating with CMOs to ensure on time closure of associated CAPAs.  Support regulatory filings for products manufactured at CMOs.

* Support creation of Annual Product Reviews, product complaint investigations, and other quality functions as required.

* Establish CMO goals/metrics and monitor and report progress. Lead or participate in CMO or cross-functional process & quality improvements projects.

The role of the Validation Engineer, located in San Francisco, is a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle with a focus on compliance with regulatory, legal and finance requirements.  We are looking for a customer-focused, highly collaborative individual to  work with delivery units to advance existing emerging business critical technology according to Roche Pharma needs. 

The selected candidate will be responsible to:

Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV).  This includes, but not limited to policies, directives, and Global Informatics standard operating procedures related to the CSV area.

Assemble global feedback on proposed or existing standards and tools and providing recommendations for new guidance/standards or revisions to existing guidance/standards.  

Provide consultation and guidance to delivery and operational units within Pharma IT to provide accurate interpretation of Roche CSV approach and requirements, information concerning regulatory requirements related to CSV in the specified area, updates on changes in the regulatory environment

Assure that processes are established across Pharma IT to support delivery and operations of compliant systems.

Gather and analyze metrics and key performance indicators to identify opportunities for process improvement

Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management function for resolution

Facilitate and leverage quality practitioners within the delivery units  to identify best practices,  and lead improvement initiatives across functional areas

Identify new training programs and/or revisions to existing training programs and approaches for delivery of training within and outside of Global Informatics

Provide change request control and support for legacy GMP systems 

Statistical Programmer (SPA-2) 

Position Purpose:

The Statistical Programmer has responsibility for statistical programming support for the Pharma Development, gRED, pRED, and/or EpiPRO organizations.  He/she supports statistical programming teams on assigned study level activities in planning, designing, and implementing statistical software solutions for the reporting and analysis of clinical trials in accordance with applicable processes.     

Major Responsibilities and Accountabilities:

 Contributes to SPA team in preparing summarized information to clinical study team members

 Assist statistical programming activities at study level or components of a clinical project as applicable

 Able to access and clarify requirements, provide statistical programming solutions and ensure their efficient implementations under supervision

 Under guidance of a senior SPA, develops approaches to meet the study and project requirements

 Assist in determining and developing approach to technical solutions

 Responsible for accuracy and reliability of results.  Builds and monitors quality in every aspect of job activities. 

 Has an awareness and familiarity with the types of risks associated with a study and the impact on the quality of deliverables

 Is aware of timelines and scope based on resourcing / priority constraints within the SPA team and understand their implications on individual work assignments 

 Builds and maintains effective working relationships with SPA team members.

 Adapts to changing circumstances, policies, work assignments, and/or team members.  Able to multi-task and prioritize between tasks

Level:
Automation Engineer I (E2)

Genentech's US Biologics Pharma Technical Development organization is looking for an Engineer I to work in our Process Development Engineering group (PDE).  PDE's role is to provide innovative engineering services to the cell culture and purification pilot plants and labs.  PDE also evaluates new automation, robotics, and process sensor solutions for Drug Substance processing.

The Automation Engineer will be expected to support the users and systems in the large scale cell culture pilot plant.  This role will require design, specification, implementation and maintenance of bioreactor control systems for both mammalian and microbial processes.  Key roles and responsibilities include:

-  Identification, evaluation and implementation of new technologies to improve the efficiency and safety of control systems at Genentech.

-  Maintenance and troubleshooting of hardware and software on the process control systems in the Process R&D Labs and pilot plants.

-  Design, implementation and support of laboratory automation systems.

-  Leading and supporting small project teams which design develop and integrate automation systems in the Process R&D laboratory and pilot plants.

-  Scope of work definition and supervision of contract labor for small and medium projects under the direction of a senior engineer.

-  Collaboration with Corporate Engineering, Manufacturing Science and Technology (MSAT) and other business partner groups on technology transfers and information exchanges.

-  Author and maintain system support and specification documentation.

-  Author technical reports and/or presentations.

-  24/7 on-call support is required for this position.

This IT Manager is responsible for managing the Portfolio processes for Research and Development IT and for providing Project Management on a variety of projects that are used by Research and Early Development.  The position also oversees Portfolio/Project Management, Budgeting, Forecasting and related processes for Research and Development IT.  The position is part of the gRED IT organization.

Responsibilities: 

• Acts as Project Manager on projects, as assigned.
• Ensures that formal project management processes (PMM) are adhered to 
• for planning, chartering, and management of strategic initiatives and 
• projects. 
• Establishes and manages project teams and core teams to develop and 
• execute project plans. 
• Monitors projects and their progress towards goals, provides status, and 
• ensures issue resolution. Manages project budget and timeline to ensure 
• that they are efficiently delivered.
• Identify and implement process improvements in solution delivery and 
• support of new and existing solutions
• Collaborates with Pharma Informatics technology groups and business 
• functional groups, to ensure project delivery and on-going support of 
• applications.
• As the Portfolio Manager for gRED IT, partners and coordinates with Finance, gRED IT project managers and functional managers, other Portfolio Managers and the business to ensure appropriate project methodologies, governance and control processes are followed.  Also coordinates annual budgeting and monthly forecast/actuals processes and acts as the gRED IT representative on larger Pharma IT portfolio process improvement efforts.  Provides support and guidance to gRED IT project managers, as needed.
• Coordinates the yearly and project budget processes, including monthly forecasting, actuals analysis and resource management processes for your area of responsibility. 
• Provides support to the Director of gRED IT, as needed, related to creating general presentations, leading certain recurring meetings, etc.
• Participates in the Leadership Team of gRED IT organization

In the position of Senior Regulatory Product Manager in Technical Regulatory Affairs, you will be accountable for the preparation of regulatory submissions and strategies supporting the product’s lifecycle and business needs.  This role within Pharma Technical Regulatory is focused on the development of strategies supporting biologic marketed products.  The successful candidate must have demonstrated leadership capabilities, a proven ability to work cross-functionally, and recognized strengths in collaboration, teamwork and communication.  He/She will be tasked to navigate and lead the preparation of complex global regulatory strategies with support from global team members representing both technical regulatory and various cross-functional representatives. The successful candidate must have an ability to develop and drive innovative solutions to complex regulatory strategies while maintaining compliance with regulations.  With a focus on biologics marketed products, he/she will also be required to provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management.  Additionally, he/she will support departmental business processes to document and improve best practices and work efficiencies.

He/she will be responsible for leading a team that delivers timely compilation and of all necessary documentation for regulatory submissions to support technical content of regulatory submissions. He/she will ensure quality; content and format of regulatory submissions comply with applicable regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics.

TheImmunology, Tissue Growth and Repair Diagnostic Discovery Department is seekinga motivated, interactive and flexible Senior Research Associate to perform researchrelated to biomarker discovery and analysis in infectious diseases. 

Theposition will report to a Scientist lead for the Department's new program inInfectious Disease and Host-Pathogen responses. The successful candidate willimplement a variety of in vitro and in vivo molecular, proteomic and cellulartechniques to elucidate disease pathways and identify relevant biomarkers, andwill be expected to make intellectual as well as technical contributions to theteam. Responsibilities: Perform wet lab experiments, generate and analyze dataand communicate findings and interpretations relevant to the Department'smission to identify predictive and prognostic biomarkers for therapeuticResearch and Development programs. Specific responsibilities will include:performing exploratory disease-oriented research utilizing samples & datafrom human infectious disease cohorts, processing and analyzing clinical trialsamples, data analysis and presentation, and contributing to experimentaldesign/planning.

The successful candidate will be a key member of the Cross-Portfolio Governance (CPG) team within PPP/Pharma Portfolio Management. The CPG team establishes and manages governance operations and decision-making processes for late stage development to enable well informed and timely corporate decisions on portfolio investment and prioritization.

The manager of LSPC Operations works in close partnership with the late stage portfolio committee (LSPC) Business Manager and is responsible for providing project management support for CPG key initiatives and for leading and managing the monthly LSPC decision-making operations cycle.

Responsibilities

• Lead and manage the monthly LSPC agenda preparation process with key stakeholders in late stage teams in efficient, collaborative and transparent way
• Write minutes for the LSPC monthly meetings
• Anticipate, identify, manage and communicate risks to the execution of the monthly operations cycle
• Support LSPC Business Manager in preparing recommendations and proposals for meetings with LSPC Chairs and other senior leadership
• Maintain LSPC Charter, process documentation and required templates for team presentations for committee decisions
• Manage CPG communications with cross-functional stakeholders
• Guide, educate and support late stage teams, finance, PPM and other key stakeholders though the LSPC operational processes
• Actively contribute to best practices and continuous improvement
• Provide project management support to key projects, and programs led by CPG members and sponsored by senior leadership

Job Skills and Expectations

• Excellent project management skills
• A strong understanding of pharmaceutical/biotech industry, drug development process and trends, and business strategy
• Customer service orientation and attention to detail
• Strong oral and written communication skills
• Experience managing process improvement implementation and change
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.

Global Product Development Biometrics Biostatistics (PDBB) at Roche/Genentech plays a key role in successful drug development by contributing expertise to the drug development process from research through entry into humans through regulatory approval and beyond. Biostatisticians collaborate on cross-functional teams with colleagues from Clinical Science, Safety Science, Regulatory Affairs, and other functions.  Statistical Methods and Research is a group of statisticians within PDBB with a mission to enhance our strategic and methodological capabilities. Current areas include portfolio decision-making, quantitative benefit-risk, regulatory statistics, and personalized healthcare, but may be extended to meet business needs.  

Key responsibilities include:

• Provide effective, timely and reliable consultancy across the company on statistical problems

• Engage in research in statistics to improve clinical trial methodology used in the development of company products consistent with corporate priorities and timelines

• Work in collaboration with Biostatistics leadership to identify and prioritize areas of potential impact that need new or improved statistical methods

• Impact drug development science beyond the company in industry forums

• Influence internal and external stakeholders to produce and implement robust drug development strategies 

• Contribute to ensure that PDBB is regarded as highly effective strategic partners in drug development whose prestige extends beyond the company

• Develop and maintain expertise in at least one core area of biostatistics and serve as an advisor to other biostatisticians and PD leadership