Purpose:

The senior utilities engineer provides technical leadership and accountability for plant and GMP utilities engineering in the delivery of capital projects and engineering services for research and development (R&D) and quality laboratory, as well as commercial and clinical manufacturing related facilities.

Responsibilities:

• The senior utilities engineer will work effectively on multi-discipline engineering capital project teams, as well as other project related cross-functional teams with representatives from departments throughout the Pharmaceutical Technical Operations and R&D organizations.

• Responsibilities may extend to all regional Americas manufacturing and research facilities, as well as the network of Contract Manufacturing Organizations organized under the Manufacturing Collaborations group.

• The primary area of focus for this position will be the execution of projects from design through commissioning and qualification. The senior utilities engineer will be accountable for:

- Planning and Execution of Projects: including project approach and resource needs, options analysis, utility systems and equipment design, engineering document development, and system ownership through the project delivery phases of plan, design, procure, construct, commission and qualification for research, cGMP and development facilities; and 

- Technical Analysis:  including utility system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design, constructability and assessment of applicable new technologies to balance performance, cost and maintainability.

• Areas of expertise include systems and equipment for purified water, water for injection (WFI), clean steam, process air, process gases and process waste, as well as associated knowledge in plant steam, plant chillers and utility piping.

• This position requires coordination of Genentech/ Roche and/or contract engineering resources.  Facilitating meetings, directing engineering firms and consultants, field supervision, equipment inspection and start-up, construction trade coordination, and training of operational staff are often required.  Success in these areas will depend upon the individual’s ability to effectively communicate, collaborate, and foster positive interactions with team members, while diligently managing adherence to project scope, budget and schedule.

• The senior engineer is expected to be an effective communicator of ideas, project goals and results.  With minimal supervision, is expected to make presentations and updates to senior management and in broader forums both internal and external to Genentech. 

• The senior engineer is expected to contribute to increasing the efficiency and effectiveness of the Engineering Technology department by contributing toward infrastructure improvements to guidelines, procedures, practices, standards and cross-functional business processes.  The senior engineer should share insights and improvements, participate in design reviews across the portfolio of departmental projects, and contribute to best practice forums across our network of global engineers and partners. 

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

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

The primary responsibility of this position will be to focus upon clinical product planning for multiple molecules; which includes partnering with Clinical Operations to translate trial assumptions into drug forecasts, utilizing SAP/APO to develop supply plans and to align these supply plans with the Technical Development Team, and partnering with Master Production Planners (MPP) to ensure plans are converted into bulk, filling, packaging, and contract manufacturing schedules which meet customer requirements.  For Finished Goods, the CDSL is also accountable for generating a distribution plan to handover to the Global Clinical Distribution team and working with this group to ensure a seamless supply chain throughout our distribution network.  The CDSL will be knowledgeable of the costs and capacities associated with our manufacturing network, and will assist the MPP in developing recommendations to balance production requirements, customer service, and manufacturing capacity.  The CDSL will assist in the execution of our Clinical Demand & Operations Planning process, in capturing supply planning metrics and in developing/implementing strategies to drive improvement in those metrics; enabling the development of robust business processes and our ability to reach our department goals.

Responsibilities:
¿ Partner with Clinical Operations teams to develop drug forecasts based upon clinical trial assumptions, design, and timelines
¿ Leverage the Generic Forecast Assumption process to apply drug forecasts to future planned trials listed in Plansource
¿ Collaborate with Development Partners to understand partner demand and timelines for trials not being run by Genentech
¿ Initiate product definition forms to enable creation of new planning and execution items in SAP
¿ Utilize clinical forecast tools to consolidate all demand for Roche/Genentech, or CMO produced drugs as well as required Other Study Drug procurement
¿ Utilize SAP to create/communicate a Master Production Plan, a depot Distribution Plan and OSD procurement plan that meets global clinical demand, inventory targets, project budgets, and manufacturing capabilities
¿ Actively participate on TDT teams to ensure alignment of demand and supply plans with TDT development strategy and budget, and capture all project driven demand in SAP
¿ Lead cross-functional Global Supply Execution Teams to drive alignment of activities enabling drug to be packaged, released, and ready to ship; meeting trial First Site Activation goals
¿ Manage inventory and production orders for assigned products; monitoring inventory levels, firming production orders, controlling lot allocations, managing expiration dating
¿ Perform required Supply Planning activities & processes driving cross functional action to ensure all drug supply plans are achieved
¿ Participate in the S&OP process as necessary, leading cross-functional process improvement RCAs

The position:

The Senior Engineer in the Process and Project Engineering Group in the South San Francisco Production Technology Department will be responsible for Process Engineering (Process Equipment Design) and Project Management of Drug Product projects for the SSF Production Business Unit.   The support areas include commercial and clinical filling lines, inspection and clinical packaging.  The candidate must also provide mentorship and direction to partner MSAT groups on execution of process engineering design and project management.  In addition, the candidate will provide Process Engineering services such as approval of P&ID changes, IQ, Material of Construction forms, Engineering Design Review and Engineering Change Records.  The candidate will be responsible for development of business systems to support efficiency and sustainability.  The candidate will also help provide strategic direction to transformation of the Drug Product manufacturing capabilities.

Description - 

An opportunity for a protein biochemist is available to join a chemical biology group in the Department of Early Discovery Biochemistry. The group uses a multidisciplinary molecular approach for target validation. Recent efforts focus on the use of peptide phage display and small molecule tools for modulating protein-protein interactions and fluorescence imaging of cellular proteins. The successful candidate will be responsible for producing proteins and peptides of therapeutic interest and their characterization by analytical methods (affinity purification, RP-HPLC, SDS-PAGE and western analysis). He/she will also investigate the functional mechanism of bioactive ligands by biochemical and cellular assays. This is a basic research position that requires critical thinking, flexibility, multitasking and the ability to learn new techniques.

Responsibilities:

Works with senior biostatistics staff and clinical monitors on clinical development plans, the design and conduct of clinical studies and in the evaluation, interpretation and preparation of study results. As part of a clinical assessment team, collaborates in the preparation and review of clinical assessments. For assigned clinical development project(s), provides statistically sound experimental design and data analysis input to meet project objectives and Health Authority's statistical requirements. Reviews all project protocols, author protocol statistical analysis sections and generate study randomizations. Develops study analysis plans as a team member; lead this effort for selected studies. Reviews case report forms to ensure that protocol objectives are met and project standards are maintained. Develops statistical programs as necessary to perform analyses, and verify data accuracy and validity. Co-author efficacy analysis results in the clinical study report. Supplies statistical input for filing submissions and in response to FDA questions. Provides support for publications. Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, workshop attendance, etc.

The MCCO Solutions team in Genentech’s IT Americas organization is looking for a motivated Sr. Software Quality Analyst to lead all aspects of Quality Assurance and QA Testing of technology projects in support of US Commercial Operations.  The Sr. SQA will be responsible for managing the work of assigned Quality Assurance (QA) resources, effectively building and tracking QA Plans and Strategies, and ensuring end-to-end quality in all phases of the project lifecycle.  

Duties:

• Plan and execute functional, performance and stress testing on applications and systems using automation and manual testing
• Maintain an understanding of leading tools and technologies for development of mission critical web, database and related applications. (Mercury Suite, Selenium, Segue, etc)
• Lead the development of SQA Test Plans, Test Procedures, SQA lab standards and tool requirements
• Identify opportunities for process improvements that streamline development activities while minimizing risk
• Mentor other team members in testing processes & testing tools in order to execute Test Plans as required
• Manage work of onsite and offshore SQA testers as required 

We are seeking a Sr. Project Manager who will manage complex projects to successful and timely decision points from Late Stage Research through Proof of Concept. The Sr. Project Manager will actively contribute to the definition of project strategy and guide the project core and sub teams to deliver on project objectives. This position will be accountable for steering drug development teams through corporate processes. Additional responsibilities include but are not limited to the following:

• Establish and maintain functionally integrated project schedules to enable accurate project, financial and portfolio analyses and ensure accurate inputs are provided into business planning processes; Ensures alignment with project sub-teams and functional partners
• Oversees and prepares project team budget including resources and costs collaborating with Finance and other cross-functional department
• Communicate, document, and archive project team activities and decisions; act as a primary contact for project team related information
• Facilitate project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders
• Identifies, recommends and implements opportunities for streamlining or other efficiency/improvements for teams and business processes.
• Responsible for ensuring the team achieves and maintains a high-level of sustainable performance, by implementing appropriate team management best practices.

• Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
• Lead efforts to provide on-going technical support for production at internal and external contract and partner sites. Includes monitoring process performance, resolving manufacturing deviations, participating in quality investigations, and providing technical approval of document and automation recipe changes to support continuous process improvement
• Lead and/or participate in global initiatives and cross-functional investigational and project teams
• Work collaboratively with site Manufacturing Science and Technology (MSAT) groups to develop and communicate best practices for process and equipment design and operation to ensure consistency and compliance across the biologics manufacturing network
• Support product impact and root cause assessments for process discrepancies and Quality investigations
• Travel within the Roche network and to contract manufacturing sites will be required
  

  Manages the implementation of Medical Data Review, both processes and application of the tools by Clinical Scientists, by providing on-site training, development of best practices, and dedicated support.  The person in this position optimizes the implementation of Medical Data Review by being an integral member of the MDR support network.

Main Responsibilities:

Provides training for medical data review tools

• Owns the scheduled training program and ad hoc on-the-job training
• Provides class room training/ one on one training as required
• Assists with the access process to medical data review tools and provides guidance
• Ensures tool users understand the data source(s) used for report generation, and assists with identification of questionable or discrepant content (includes some UAT)
• Contributes to the co-ownership of the standard training materials for MDR tools (e.g. J-Review)
• Co-develops applied job aids to support end users in use of the tools (e.g. tips and tricks sheets)
• Maintains real-time training attendance records
• Updates materials as systems undergo changes and alerts end users of changes as they occur

Provides support for medical data review

• Acts as a main point of contact for Clinical Scientists with questions on Medical Data Review processes and documentation
• Acts as the main point of contact for CDM report developers and Informatics (e.g. for specification set up and UAT)
• Acts as a main point of contact for teams engaging with CROs for MDR of external data and champions the standards used with vendors
• Provides guidance and actually develops ad hoc report objects to support ongoing MDR
• Actively solicits input from users to identify areas requiring additional support

• Delivers desk-side first level system support to end users, and understands when resolution requires escalation

• Participates in meetings with tools’ owners to ensure end users requirements are met
• Co-maintains an on-line PDC communication/document repository

Tracks system compliance

• Monitors tracking reports for tool compliance and performance of reports
• Reviews and provides the Informatics team with regular updates on status and metrics using standard/automated reports

Provides input into the global development of best practice for MDR

• Promotes knowledge sharing across the Function and within Therapeutic Areas to improve MDR best practice
• Provides input into the development of best practices of MDR Tool use and advises on the optimal use of standard tools and templates
• Proactively gathers change requests for new/different report objects or changes in processes or standard templates
• Supports the set up and maintenance of report objects built per study for medical data review
• Encourages and champions standard report objects wherever possible (cross program/TA)
• Proactively incorporates learning and recommendations from users
• Contributes to activities for improving and maintaining the quality and effectiveness of tools within Clinical Science.
• Participates in local and/or global initiatives that focus on the tools
• Makes recommendations for improvements to Informatics and Developers
• Partners with end users in proposing creation/revision of report objects
• Uses Informatics, Developers of tools for information and knowledge based resource
• Shares information across the MDR Specialist team and MDR Network
• Maintains oversight of external available tools and functionality

System support management

• Reviews and approves relevant System Development Life Cycle documents
• Contributes to future upgrades and assessment for improvements, new releases, replacement software
• Provides proactive support in terms of communication regarding updates and best practice

As a Principal Staffing Consultant, you will play a lead role in managing the recruiting and hiring programs for our Product Development Staffing 

Main Deliverables:

1. Play a lead recruiting role for approximately 100 positions annually, with an average requisition load of 30-40.
2. Play a lead role in key Product Development  wide staffing initiatives, including those supporting our diversity and hiring best practices programs
3. Partner actively with HR Management to drive internal talent development and succession planning programs
4. Provide original thinking to staffing challenges and execute on ideas for improving patterns of work

Main Accountabilities:

• Deliver Recruiting Results
• Recruit with Insight and Strategy
• Innovate and Expand Possibilities
• Value Collaborations, Communication, and Teamwork
• Execute on Tactics, Tools, and Technology

Full Responsibilities:

• Managing expectations of hiring managers and candidates, identifying and resolving issues
• Drive the employment process and strategies within assigned organization, including developing complex recruiting strategies
• Demonstrate thorough understanding and adherence and enforcement of internal staffing process as well as contribute to the development of staffing process improvements
• Ensures recruiting solutions are consistent with Corporate Staffing goals and objectives
• Partner with Diversity and sourcing counterpart to develop and implement sourcing plans and strategies for your client groups while ensuring that the elements of diversity and organizational fit are included in the recruiting and hiring process
• Proactively manage escalation process related to all requisition activity (internal vs. external challenges)
• Perform executive recruiting, including identifying appropriate Contingency or Retained Search firms, maintaining relationships and partnering to ensure that candidates are interviewed expeditiously
• Develop advertising strategies for specific groups and coordinate advertising activities with recruitment advertising agency
• Build and maintain cross-functional relationships across HR and Staffing
• Utilize, update and maintain applicant tracking system and CRM
• May provide staffing reports and metrics
• Present information on results and metrics at different levels (i.e. to employees, peers and senior level HR and client groups)
• Act as point person for clients in providing staffing reports and metrics
• May Lead and or participate in HR related projects or enterprise wide initiatives.
• Partner with Client Group on internal talent management, including succession planning, talent review and internal candidate movement
• Coach managers in providing feedback to candidates, developing offers, determining competencies, coordinating and training interview team
• Partner with Diversity and HRDs to develop and implement a recruiting strategy that ensures our candidate pipelines are diverse
• Conduct interviews using in depth behavioral and skills assessment techniques
• Educate hiring managers on legal implications in hiring
• Adjust the strategy and align it with the changing needs of the business
• Ensure your compliance with EEOC/OFCCP regulations
• Act as project manager for client focused staffing projects (not just req focused)
• May partner with finance in determining headcount for client group, as well as manage the reconciliation of budgeted headcount vs. actual headcount
• Work with Staffing Manager on recommendations for the EC Group recruitment/relocation budget
• Oversee relocation/recruiting budget for individual client group at the officer level
• Manage multiple relationships, both internally and externally
• Attend professional conferences and networking events
• Responsibility for Conference/Event management related to external recruiting, partner with Corp Staffing in strategic direction of event, and determine ROI for event participation

The successful candidate will be involved in late-stage pharmaceutical development ofmonoclonal antibodies, antibody-drug conjugates, and delivery systems for clinical evaluation and commercialization. The responsibilities of this role include formulation development, evaluating product stability and throughout the manufacturing process and performance in diverse delivery systems, as well as biophysical characterization, drafting technical documents and contributions to regulatory filings. Applicants should be comfortable working both independently with minimal supervision and as part of a team to support the development of recombinant protein therapeutics. The successful candidate will also be expected to participate on cross-functional project teams. The position offers opportunities for professional and scientific growth in a dynamic, intellectually stimulating and fast-paced work environment.

Lead cross functional project teams to:

- Deliver project goals on budget and on schedule
- Develop customer requirements into an approved project charter
- Analyze business, process and systems performance, and identify improvement opportunities
- Make recommendations to Management based on business case and analyses
- Lead decision making support and make recommendations regarding best options
- Communicate proactively with stakeholders regarding progress, issues and plans for resolution
- Develop and use project plans to coordinate participants and track and report progress
- Ensure improvement methodology and tools are utilized effectively to maximize benefits
- Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals

Competencies:

Job Knowledge and Scope – Applies extensive theoretical and cross-functional expertise in the context of company objectives to independently address complex problems. Determines methods and procedures on new assignments (defines scope and approach). Occasionally creates course material and delivers advanced lectures to internal and external audiences.

- Collaborative Leadership – Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment.  High tolerance for ambiguity, able to create order from chaos.

- Ownership and Accountability – Takes accountability for actions, drives results, learns from mistakes.  Is direct and truthful and therefore widely trusted - delivers on promises, goals, and expectations.  Makes quality decisions and resolves problems rapidly. Asks “what can I do to help?”.

- Communication – Ability to communicate effectively up and down, at all levels of the organization, present complex and/or new ideas with clarity and simplicity.

- Planning/Organization – Excellent planning and prioritization skills with the ability to multitask and adapt.   Able to synthesize large amount of information.  Able to deliver results despite shifting environment.

- Analytical Problem Solving – Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes.  Innovative and effective in solution development, risk mitigation, and execution.

- Customer focused – Partners with customers, looks ahead to predict future customer needs. Manages expectations.
- Supervision – Work is performed under limited direction. Establishes own work priorities and timelines. May provide guidance and coordinate work activities of other personnel.

- Job Complexity & Decision-making – Develops solutions to a variety of complex problems and initiatives. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Works on complex issues where analysis of situations or data require an in-depth evaluation of variable factors, including inter-organizational impact.

- Interaction – Interacts with senior internal and external personnel on significant matters. Represents the organization as a prime contact on initiatives and projects.  Can facilitate RCA's, lessons learned, K-T analyses and FMEA's.  Can facilitate strategic discussions with leadership teams.

The North America Commercial Group generates $13B in sales and includes 4000 employees, 1500+ reps, and major sites in South San Francisco, Nutley, Indianapolis, Vacaville, Hillsboro, and Mississauga.  The US affiliate is organized into Business Units such as BioOncology, Immunology/Ophthalmology, Virology, and Metabolism as well as organizations like Business Operations, Managed Care, and Customer Operations.  Since 2008, all major technical solutions and components supporting Genentech US Commercial Operations were replaced or upgraded, then extended to support Roche Canada.  The Commercial IT team continues to implement innovative technologies to best enable the business stakeholders.

The Programmer Analyst will provide technical expertise to the Application Services - Sales & Marketing team supporting the North America Commercial Group.  This position focuses on the continuing evolution, implementation, and support of existing and new vendor-based systems to support critical business processes.  The Programmer Analyst will work with a Poland-based development team and onsite contractors as needed to complete deliverables.  

Key Responsibilities:  

• Participate in business process analysis, use case creation, and requirements definition.
• Responsible for designing, prototyping, developing and unit testing solutions for projects and maintenance & enhancement releases.
• Create and maintain technical specifications, system interface diagrams, unit testing scenarios and system support documentation.
• Follow best practices and standards to ensure technical compliance.
• Provide root cause analysis to resolve complex issues as part of support.
• Work on multiple priorities at the same time and manage the work/time effectively.
• Demonstrates accountability by contributing to the completion of assigned tasks.
• Participate in projects as assigned.

Senior Finance Manager 

JOB DESCRIPTION:

Position is dedicated to supporting the financial management of the South San Francisco Production Business Unit (BU). The position will report to the Associate Director of Finance for South San Francisco Production and is part of the Technical Operations Finance group, which is charged with the financial stewardship of Genentech's Technical Operations organization.

MAJOR RESPONSIBLITIES

Responsible for the financial planning, analysis, and reporting activities of the South San Francisco Drug Product Manufacturing operation. Act as point of contact between the operating group and the finance organization. 

Financial Management & Controls

• Perform month-end close activities, including monthly production activity, cost allocations and reconciliation of inventory balances. Identify, investigate, and resolve potential issues within tight time constraints. 
• Manage and control expense and capital transactions through the corporate accounting system (SAP BW) including maintaining and reconciling accrual transactions. 
• Communicate effectively with internal finance departments, including Vendor Finance, R&D Finance, Capital Finance, Corporate FP&A and others to ensure quick and accurate resolution to financial issues.
• Support and direct Internal Control audits.
• Actively participate in development of new business systems and metrics, working with the Technical Operations Finance and Corporate Accounting organizations as necessary to define and implement. 

Planning and Analysis

• Work with operations teams to provide input on the development and tracking of appropriate metrics and goals for planning horizon. 
• Lead business partners in the execution of planning exercises (forecasts, budgets, long-range plans): 
• Coordinate efforts of business partners to prepare operating expense, headcount, and capital forecasts so that all submission requirements and all deadlines are met. 
• Analyze budget forecast proposals for strategic consistency and suggest modifications as appropriate. 
• Provide support for all presentations and submissions. 
• Identify and execute opportunities to improve operational results. Partner with Business Unit management to achieve targeted costs and continuously improve.
• Analyze spending and cost of production monthly and provide direction to BU management using SAP. 
• Develop financial decision frameworks for operational issues and lead analysis through final recommendation. 

Reporting

• Perform efficient and pertinent month-end reporting, including investigation of spending and manufacturing variances. 
• Prepare and present monthly financial results to site and financial leadership.
• Use financial reporting to direct BU management toward areas of improvement or to surface operational issues.
• Prepare and present quarterly capital spending updates to site and Technical Operations leadership. 
• Support Site Capital Governance Team in Capital Reporting, Planning and Financial Analysis. 

MAJOR SKILLS TRAITS:

• Demonstrated analytical acumen and problem-solving skills.
• Independent self-starter and proactive leader. Seeks to continually improve business processes. 
• Strong communication and presentation skills and demonstrated success building partnerships across organizational boundaries (within a manufacturing environment desired). 
• Commitment to customer service with a strong sense of ownership for projects and results. 
• Must be able to work in a fast-paced environment that often requires commitment of more than 40 hours week.

The Sr. Finance Manager plays a pivotal role providing financial support for Global Biologics Technical Operations (PTB).  The Biologics Operations manufactures over 70% of worldwide Pharma revenue and is the primary supplier of clinical production.

This position reports to the Head of Finance – FMTB Financial Planning & Analysis and Accounting and supports the financial planning and analysis of 11 manufacturing sites in 9 locations and $2.5B of spending. 

This is a high-profile, global role that interfaces with senior management and cross-functional finance teams such as Supply Chain, Quality and Operations.  

Specific Responsibilities:

• Support forecast, budget and long range planning process for PTB, coordinating with finance teams across US, Singapore and Europe.  Produce executive updates and analyses.
• Provide support to local Genentech manufacturing finance functions in planning activities, such as financial systems interface (TM1) and process management.
• Partner with global finance teams to explain underlying business drivers on variances and alert management on risks and opportunities. 
• Consolidate, analyze and communicate financial performance for global Biologics.
• Collaborate with financial systems team to improve financial models, processes and analyses.
• Business partner with several leaders on forecasting and reporting their cost center budgets. 

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 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: