Title: Engineer I
Job Category: Manufacturing
Department: Process and Project Engineering
Level: E2/E3
 

Responsibilities:

This position is for a Process Engineer reporting to a Manager in the Process and Project Engineering Group in the South San Francisco Production Technology Department.  The candidate will be responsible for Process Engineering and Project Management of both Drug Substance and Drug Product projects for the SSF Production Business Unit.  Primary responsibilities include supporting design, construction, startup, and upgrades to manufacturing equipment.  The candidate will provide mentorship and direction to partner MSAT groups on execution of process engineering design and project management.  The candidate will also provide Process Engineering services such as approval of P&ID changes, IQ, Material of Construction forms and ECOs on a rotating basis.  In addition, the candidate may support development of business process improvements to support efficiency.  The candidate will be hired as an Engineer I or Engineer II based on level of experience.

Contract Services Manager 

Contract Services Managers are responsible for contract services (including contract set-up, membership and affiliation assignment and maintenance) and/or customer payments in accordance with accuracy and compliance requirements. Customer payments may include responsibilities, as assigned, for processing fees, rebates, discounts and chargebacks, as per the terms of each contract. Additionally, Contract Services Managers act as subject matter experts (SMEs) on SPCM Contract Operations processes, collaborating with Contract Operations partners and stakeholders in various meetings, initiatives and projects. Expertise in the processes, calculations, systems and Standard Operating Procedures (SOPs) that support contract services and customer payments is critical to success in this position. Contract Services Managers, by comparison to Associate Contract Services Managers, also have responsibilities for developing complex analyses and reports, reviewing from the work of less experienced team members, performing contract set-up and structure for other team members, managing Internal Control Over Financial Reporting (ICFR) tracking and monitoring activities, and leading projects to improve processes and procedures.

• Acts as a lead SME for assigned contracts, other activities, SPCM Contract Operations systems, processes and SOPs
• Plays a lead role in cross-functional initiatives involving new/updated pricing and contracting strategies, terms, conditions, language and the like 
• Proactively seeks out complex information on changes in laws, regulations and other external factors and dynamics. Works with manager and other internal partners/stakeholders to interpret the information and assess its effect on current contracting models, pricing, discounts, rebates, chargebacks, compliance and the like. Develops appropriate responses, including recommending changes in complex pricing and contracting strategies, programs and contract administration
• Plays a lead role in development, education, communication, implementation and ongoing maintenance of Contract Operations SOPs, systems, processes, data, reporting templates and the like. Includes serving as a liaison for technology-related projects to ensure systems or enhancements are designed to meet the operational needs of Contract Operations and supporting testing for new or updated systems 
• Works with manager and others to establish appropriate performance metrics for monitoring, evaluating and reporting on contracts, contract performance and other business, legal and regulatory requirements
• Plays a lead role in development and delivery of Contract Operations training; including conducting training for other staff members and, as appropriate, others outside of the department
• As assigned, leads or otherwise participates in and supports other special projects
• As assigned, may perform some or all of the following:
• Enters contract information into departmental systems and databases Performs contract set-up and maintenance. Includes 340B Program Integrity support and assigning customers to appropriate contract groupings and class of trade (membership and affiliations), coordinating and managing contract term reviews
• Collaborates with other departments to determine appropriate pricing eligibility for new managed care customers; identifying customer entities, class of trade and appropriate contract pricing
• Implements departmental changes arising from such things as complex pricing strategies, updates to operating procedures, or internal policies affecting Contract Operations
• Uses relevant contract terms, conditions and other regulations, policies, etc. as well as appropriate systems and tools to evaluate, calculate, validate and process customer payments 
• Prepares payment packets as per the terms of each assigned contract. Ensures packets are routed through to all appropriate partners/stakeholders for review and approval
• Works with Customer Finance and other partners/stakeholders to track customer payments and ensure accurate and timely payments are made to customer accounts. Helping ensure penalties are avoided 
• Develops and evaluates contract performance using approved financial modeling templates
• Completes ICFR tracking and reporting, as per business and legal requirements and departmental policies & procedures
• Prepares, obtains approval for and ultimately publishes departmental scorecard reports, customer business review reports, various compliance and other ad hoc reports
• Performs ongoing membership and affiliate maintenance. May include updating membership/affiliation on an exception basis in accordance with business rules 
• Responds to questions/inquiries; may include policies, pricing, payment calculations, contract performance, complianc...

Department:   Site Services
Cost Center Name:  Site Engineering
Based on candidate experience the position can be either leveled as a Principal or a Senior Program Manager (E5/E4)

Responsibilities:

This position manages and directs a portfolio of construction projects <$10M at the Genentech South San Francisco campus (including Dixon and Redwood City). The program manager is the direct interface between an internal Genentech customer group and the Site Engineering outsourced project delivery service provider on each project within their portfolio and is accountable for the successful delivery of the entire portfolio while ensuring a high level of customer service.  The program manager role is strategic, customer facing, and leverages performance management principles to accomplish the work.  Key responsibilities include:

Customer Interface and Project Planning
The program manager is the direct interface between Site Engineering and the key representative(s) of a major Genentech functional group such as Research, PTD, Workplace Planning, Facility Operations & Maintenance, SSF Production, Energy Program and EH&S.  The program manager will be highly engaged with the customer to assist in developing new project scopes, providing input on initial costs and schedules for that customer’s portfolio of work (cLRP level estimates), and assist the customer in driving project starts.  To support this work in the Planning/Project Initiation stage, the program manager will engage resources as appropriate for constructability reviews, alternative analysis, scheduling, estimating, etc., to assist the customer in creating initial scope documents, which capture the initial scope, schedule, estimate, conceptual layoutsplans and key planning assumptions.  Service Level Agreements are developed and adhered to for the specific customer group.

Portfolio Management
The program manager will be responsible for the portfolio of projects executed for their customer group, overseeing all of the projects from planning stage to closeout and completion. The program manager will work with the project delivery service provider to assign projects to project managers from the service provider, and will be engaged with the status of each of these projects, providing input and strategic direction between them based on customer needs.  The cash flow and budget & resource management of the functional area’s portfolio shall be the responsibility of this role, as will assisting the customer in prioritizing their portfolio to meet available project resources. A key deliverable for the program manager will be the creation of a portfolio financial report, detailing the budget and cash flow status of the portfolio on a monthly basis.

Project Delivery
The basic function of this position is to ensure delivery of innovative and cost effective design and construction strategies for various construction projects at the Genentech South San Francisco campus (including Dixon and Redwood City) for each internal customer group.  The project portfolio consists of multiple small projects with total project costs up to $10M each. The typical program manager’s portfolio consists of 40-60 active projects at any given time, and totals approximately $12M-$20M of annual spend. The projects are delivered through a third party supplier who operates within the limits established by agreed upon scopes, budgets, and schedules of approved projects and makes decisions to control the work within these limitations.  The third party supplier executes projects through established project delivery processes, which includes key stakeholder engagement in defining project requirements and scope, business case justification, economic evaluations required to secure financial approval, and ensuring that projects meet intended functionality while controlling costs. The program manager works with the customer to define the project at a high level in the “Project Initiation” stage, and passes it to the project delivery service provider to initiate the project into the “Concept Design” stage, where the service provider takes over full responsibility of the project through completion.  The program manager oversees the work of the service provider with performance based / performance managed oversight.

Finally, a key role for the program manager is leadinggiving presentations to upper management to obtain funding for each project, usually in stages (i.e design phase funding, then construction phase funding). The service provider will prepare initialdraft presentation materials for the program manager, but final presentation creation and delivery to management is a key role of the position. The approving audience will consist of the Site Services Vice President and Directors. For proj...

Note: This position is posted as E3/E4 depending on skills and experience.

The job takes place in an office environment and requires computer use >4 h/day, prolonged sitting, and repetitive motion (keyboarding, mousing, etc.). Occasionally job requires lab investigation and potential exposure to a number of chemicals, including but not limited to: acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.

Main Purpose of the Position:

·         Provide commercial and clinical product support to ensure highest level of compliance, uninterrupted supply to patient, and continuous improvement in business processes and methods.

·         Represent Quality Control in Product Quality Teams

·         Draft Annual Product Quality Report and Annual Trend Report

·         Ensure Quality Control is ready to execute commercial & clinical manufacturing campaigns

·         Ensure effective corrective and preventive actions are systematically identified, analyzed, implemented and documented to prevent recurring problems and improve product and process quality.

·         Perform tasks and work to achieve company goals and organizational objectives.

Job Duties/Responsibilities:

• Apply extensive theoretical and cross-functional expertise in the context of company objectives to independently address complex problems
• Subject matter expert in test methodology, systems, or operational process
• Review data and assess against established acceptance criteria
• Perform technical review of data derived from complex tests, including those outside their primary area of expertise
• Evaluate data to identify trends and/or establish limits
• Identify and resolve discrepancies. Design and execute quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
• Review and approve technical / investigation reports.
• Identify, troubleshoot, and solve technical problems.
• Independently identify and lead process improvements and develop resolution of complex gaps.
• Provide input to and oversight for assay transfer and assay validation
• Act as a subject matter expert for equipment qualification and maintenance requirements, as assigned.
• Assure and apply cGMP throughout operations
• Design, develop, and/or approve training material. Receive and provide training as necessary.
• Lead collaborations to support complex and/or multi-site projects
• Serve as subject matter expert in internal and external audits and regulatory inspections
• Write protocols, procedures and reports
• Meets scheduled performance of 95% on time.
• Perform other duties as requested by managers to support Quality activities.
• Interacts with senior internal and external personnel on significant matters.
• Represents organization as a prime contact on initiatives and projects.
• May provide guidance and coordinate work activities of other personnel.
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact.

Capabilities Identified for Success:

• Accountability
• Attention to Detail
• Communication
• Organization and Prioritization
• Policies, Process, Procedures
• Teamwork

The 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:

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

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.

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.

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.

Job Summary

The Senior Statistical Programmer Analyst (Senior SPA) works with cross-functional teams in Medical Affairs and external vendors and leads the activities in the planning, design, development, implementation and management of software and data to fulfill reports and summarized information required in support of post-marketing clinical trials, registration studies, investigations and assessments of claims databases, including health economics and outcomes research projects for Genentech and Roche products. The Senior SPA also supports internal and external requests for input into relevant documentation and materials, such as manuscripts, conference posters and presentations.

Job Responsibilities:

• The Senior SPA provides expert guidance and direction regarding statistical programming design to support timely, targeted and accurate reporting and outcomes from assigned medical affairs projects.
• He/she works closely and collaboratively with internal cross-functional partners to ensure thorough representation and alignment of cross-functional programming, data and reporting needs and objectives.
• He/she expertly manages external vendor partners supporting software developments, enhancements, maintenance and reporting to ensure consistently on-time, on-target, and accurate deliverables.
• He/she provides timely, accurate and adequate responses and inputs to/into internal and external questions, medical affairs documentation and materials.
• He/she competently and independently develops, manages, and maintains software analysis data and reporting deliverables for assigned Genentech and Roche products.
• The Senior SPA provides technical solutions to a wider range of problems with higher level of complexity, independently determines and develops approach to solutions, and recommends technical and process solutions that can be used or developed to increase efficiency of project work.
• The Senior SPA also effectively represents the department, as assigned, on cross-functional projects or work teams, and also helps on-board new team members, as appropriate, and completes special projects as assigned.

Responsibilities      

• Perform Quality review and approval of method validation and qualification reports
• Perform technical and compliance review of analytical testing results for bulk, final product, pre-clinical, cell banking and stability products
• Compile analytical data for bulk, final product, pre-clinical, cell banking and stability products
• Assess and approve discrepancies of clinical and pre-clinical products
• Review and approve COA, COT and stability statements
• Technical proficiency in analytical methodology and adherence to cGMP compliance
• Train colleagues on assay review and analytical methodology as appropriate
• Identify and implement process improvements
• Accomplish corporate, operational and departmental goals
• Exert influence in the development of objectives and long range goals of the organization
• Make independent decisions around complex issues in alignment with Roche policies
• Support internal and external audits
• Work with internal departments and outside vendors, collaborators and partners concerning projects and commitments
• Meets scheduled performance of 95% on-time
• Mentor and supervise (as required) other staff members on QC related, processes and projects.

GENERAL POSITION SUMMARY/PURPOSE:

Roche’s PDS organization is structured by product development phases, therapeutic areas and sites.  PDS enhances healthcare for patients by understanding and communicating the safety profile of Roche medicines to optimize their benefit-risk profile. Principal Safety Scientists in the Licensing and Early Development (LEAD) group supporting the Genentech Research and Early Development (gRED) organization will be responsible for the oversight of personnel and activities focusing on safety-related operational support of the early development teams within gRED. Principal Safety Scientists will be responsible for both the coordination of these activities and supervision of Clinical Safety Associates (CSA) within the LEAD-gRED group, and for individual contribution to these activities for a portion of the portfolio.  The Principal Safety Scientist will report to the Associate Head of LEAD-gRED Safety Science.

Cross-Functional Team Membership 

• Ensure appropriate coverage for all Protocol Execution Teams (PET/CPET) or Study Management Teams (SMT) for assigned molecules via supervision of CSAs and via individual contribution where needed.  Coordinate and liaise with the LEAD_gRED Associate Head and the gRED PET Leaders (PETL/CPETL) to ensure coverage of the necessary activities.  
• Proactively interface with gRED Protocol Execution Team Leader (PETL) to identify operational support needs for Safety Management Team (SMT) and/or Protocol Execution Team (PET) and prioritize coverage as needed
• Acts as single point of contact for CROs and affiliates with respect to safety operations activities
• Coordinate with PETLs to provide support to CRO regarding scope of work, requests for proposals, safety management plans, and kick-off activities

Product Development Safety-Related Operational Support for gRED early development teams

• Demonstrate advanced knowledge of safety reporting concepts, focused on standards set out in ICH and FDA guidelines for drug safety reporting requirements.
• Assists gRED Clinical Operations with ensuring appropriate inclusion of safety reporting information for investigator and site training; Independently performs clinical trial reconciliation (as applicable). 
• Review and address deviations in safety reporting sections of protocols vs protocol template; review and implement protocol specific reporting requirement e.g for Adverse Events of Special Interest; and ensure corresponding database and reporting processes are in place (e.g. IMP designation, appropriate listing of protocol in ARISg).
• Contributes to safety reporting sections of periodic reports (e.g. IND Annual Report, DSUR).
• Provide general assistance and expert input to the LEAD-gRED team members with the PDSS-PDSO interface. 

Process

• Demonstrate knowledge of requirements of clinical trial processes including CRO management, investigator and site training needs with respect to safety reporting, and safety data exchange agreements (SDEA).
• Coordinate SDEA process to ensure liaison between PET, PDSO representatives, and DSL members.
• Expected to play an advanced, expert role in PDS’s/PDSS’s policies, procedures, processes and other infrastructure developments.

Managerial activities

• As needed or otherwise appropriate, assists with recruitment, training, and/or coaching of new or less experienced PDSS staff members. 
• Ability to mentor and supervise CSAs.
• Define port-folio responsibilities for CSAs and set clear priorities.

Other

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of the LEAD-gRED early development safety organization to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned activities.
• Maintains the highest standards and levels of knowledge in the specific areas assigned.
• Completes and/or leads other special projects, as and when assigned, or otherwise requested.  Expected to contribute to PDS and PDSS beyond the bounds of his/her position and products; including leading and/or participating on cross-functional teams and work groups. 
• Provides additional support to his/her manager, and others, as needed. 
• Consistently complies with all governing laws, regulations, Roche SOPs and other guidelines.

Main Purpose of the Position

* Manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug substance (DS) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing, and site decommissioning upon completion of the contract.  

* Establish and maintain alignment between CMO site business, operational and quality objectives and plans and Roche’s commercial and manufacturing strategies and plans.

* Establish and manage business, operations, and quality relationships and communications between Roche and the CMO as the Roche’s single point of contact for the contract manufacturing relationship at the Joint Management Committee and Joint Steering Committee levels.

* Build and lead cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operational and quality objectives, plans, and performance goals.

* Provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.

* Manage the performance and development of direct reports as required to achieve organizational and department goals and a productive work environment.

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

1.   Selection.   Build and lead the Roche cross-functional team charged with for identifying, evaluating, and selecting and negotiating a contract with a CMO for bulk contract manufacturing, specifically:

* Develop CMO selection plan, define contracting manufacturing requirements and evaluation criteria, and identify and screen CMO candidates.

* Develop Request for Proposals (RFPs), and solicit and evaluate contract manufacturing proposals.

* Lead due diligence visits, analyze and evaluate CMO proposals, and develop recommendation(s) for CMO selection.  Drive decision-making for CMO recommendation through appropriate governance committees.

* Lead contract negotiations for technology transfer and manufacturing and supply agreements.

2. Implementation.  Build and lead the cross-functional team charged with transferring, qualifying, and achieving regulatory licensure the process and analytical technologies (“technology transfers” for manufacturing Roche’s DS products at a CMO’s manufacturing facility, specifically:

* Lead the Technology Transfer project for Roche through regulatory licensure of the CMO’s facility for routine cGMP manufacturing, including serving as the Leader of the Joint Management Team.

* Plan and manage the transfer of Roche’s DS manufacturing process(es), analytical testing technologies, and supply chain processes to achieve product and process comparability between the donor and receiving sites.

* Manage the project governance structure, including identifying and managing issue resolution and milestone stage gate reviews.   

* Oversee and manage contractual commitments, obligations, and processes, including milestone dates, financial terms, dispute resolution, and materials and equipment.

3.   Site Management.  Build and lead the cross-functional team charged with managing contract manufacturing at CMO following regulatory licensure, specifically:

1.1. Business

* Serve as Roche’s Site Manager, actively managing the on-going relationship with CMO to ensure Roche’s expectations for product quality, cGMP compliance, costs, and production targets are clearly understood, well-documented and consistently met.

* Lead project team meetings and technical operations meetings.

* Coordinate and manage visits and contact between Roche personnel and the CMO.

* Establish and maintain a Joint Service Agreement with the CMO that defines roles and responsibilities, business processes, systems and tools, supply chain assumptions and standards, and performance metrics to foster an effective and efficient business relationship. 

* Manage and monitor contractual commitments, obligations, and processes, including milestone dates, financial terms, schedules, materials, and equipment.

1.2. Operations

* Serve as site Technical Lead, coordinating technical review of process data and proposed facility, equipment, system, or process changes with Roche Subject Matter Experts (SME's).

* Facilitate issue resolution and problem solving within CMO site, with Roche functional departments supporting Contract Manufacturing, and through the agreed project governance structure as appropriate.

* Coordinate cross-enterprise forecasting, capacity planning, scheduling, and inventory management processes for critical raw materials and DS.  

o...

LOCATION:  San Francisco, CA or Rocky Mount, North Carolina

Description:  This particular position of Principle Site Manager in the North American Steriles CMO organization will have the primary responsibilities of site management of Drug Product Diluents at a Contract Manufacturer.   This role will be a position that will be the “Person in the Plant (PIP)” located in Rocky Mount, North Carolina. 

Job Responsibilities:

* Manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug product (DP) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing, and site decommissioning upon completion of the contract.  

* Establish and maintain alignment between CMO site business, operational and quality objectives and plans and Roche/Genentech’s commercial and manufacturing strategies and plans.

* Establish and manage business, operations, and quality relationships and communications between Roche/Genentech and the CMO as the Roche/Genentech’s single point of contact for the contract manufacturing relationship at the Joint Management Committee and Joint Steering Committee levels.

* Build and lead cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operational and quality objectives, plans, and performance goals.

* Provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.

* Manage the performance and development of direct reports as required to achieve organizational and department goals and a productive work environment.

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

1.   Selection.   Build and lead the Roche/Genentech cross-functional team charged with for identifying, evaluating, and selecting and negotiating a contract with a CMO for bulk contract manufacturing, specifically:

* Develop CMO selection plan, define contracting manufacturing requirements and evaluation criteria, and identify and screen CMO candidates.

* Develop Request for Proposals (RFPs), and solicit and evaluate contract manufacturing proposals.

* Lead due diligence visits, analyze and evaluate CMO proposals, and develop recommendation(s) for CMO selection.  Drive decision-making for CMO recommendation through appropriate governance committees.

* Lead contract negotiations for technology transfer and manufacturing and supply agreements.

2. Implementation.  Build and lead the cross-functional team charged with transferring, qualifying, and achieving regulatory licensure the process and analytical technologies (“technology transfers” for manufacturing Roche/Genentech’s DP products at a CMO’s manufacturing facility, specifically:

* Lead the Technology Transfer project for Roche/Genentech through regulatory licensure of the CMO’s facility for routine cGMP manufacturing, including serving as the Leader of the Joint Management Team.

* Plan and manage the transfer of Roche/Genentech’s DP manufacturing process(es), analytical testing technologies, and supply chain processes to achieve product and process comparability between the donor and receiving sites.

* Manage the project governance structure, including identifying and managing issue resolution and milestone stage gate reviews.   

* Oversee and manage contractual commitments, obligations, and processes, including milestone dates, financial terms, dispute resolution, and materials and equipment.

3.   Site Management.  Build and lead the cross-functional team charged with managing contract manufacturing at CMO following regulatory licensure, specifically:

1.1. Business

* Serve as Roche/Genentech’s Site Manager, actively managing the on-going relationship with CMO to ensure Roche/Genentech’s expectations for product quality, cGMP compliance, costs, and production targets are clearly understood, well-documented and consistently met.

* Lead project team meetings and technical operations meetings.

* Coordinate and manage visits and contact between Roche/Genentech personnel and the CMO.

* Establish and maintain a Joint Service Agreement with the CMO that defines roles and responsibilities, business processes, systems and tools, supply chain assumptions and standards, and performance metrics to foster an effective and efficient business relationship. 

* Manage and monitor contractual commitments, obligations, and processes, including milestone dates, financial terms, schedules, materials, and equipment.

1.2. Operations

* Serve as site Technical Lead, ...

Purpose:

This Principle Technical Manager will manage the Quality oversight related to sterile diluents manufactured at a Contract Manufacturing Organization (CMO) located in North Carolina.  This person will be a key member of the CMO governance team to support right to operate and supply of diluents packaged with several critical Genentech/Roche products.

Responsibilities:

·         Influence and drive Right to Operate and continuous improvement to achieve compliant and reliable supply of diluent for Roche products.

·         Establish and monitor CMO Quality goals and metrics to drive continuous improvements

·         Recommend, implement, and drive strategic objectives and goals of the CMO relationship

·         Facilitate issue resolution and problem solving within CMO site, with Roche/Genentech functional departments supporting Contract Manufacturing, and through the agreed project governance structure as appropriate.

·         Manage the release of product, including batch record review, investigations, change controls

·         Partner with the CMO to ensure proper aseptic control during Roche operations

·         Observe end-to end production activities that include filling, terminal sterilization, visual inspection, and labeling

·         Work with CMO to align requirements for visual inspection of diluent

·         Make decisions if issues arise during production

·         Support validation activities, product complaint investigations, creation of Annual Product Reviews, and other quality functions as required

·         Develop/maintain quality risk management plans and risk logs; utilize risk management tools to identify and mitigate CMO quality and compliance risks 

·         Ensure that CMO meets Roche Pharmaceutical Quality Standards (PQS)

·         Participate in regulatory inspections and GNE compliance audits

·         Develop and negotiate Quality Agreement with CMO

·         Support any regulatory filings for diluent manufactured at CMO

·         Present quality topics to varying governance bodies, such as Quality Review Boards, Operational Review Meetings, and Roche/CMO Steering Committees

·         Serve as the Quality representative on cross-functional and multi-site teams

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