The Manager / Senior Manager will support the late stage PPP team as itdelivers on a range of projects in support the late stage oncology portfolio.  Key activities forwhich PPP is responsible include:

• Portfolio Management and Reporting
• LifeCycle Team, Planning, Governance and Decision Support
• Strategic Projects at the TA Level and Cross-Portfolio
• Governance / Support for Late Stage Portfolio Committee

The role requires ability to providestrategic, analytical and systems support to late stage teams, TA heads, andother stakeholders in the Roche organization.

Responsibilities

Representative responsibilities associatedwith the role are detailed below:

• Portfolio Management and Reporting
• Participate on multiple lifecycle teams and ensure that portfolio reflects ongoing investments in programs
• Prepare quarterly reports on progress of portfolio and implications (incl. strategic context) for senior managers
• LifeCycle Team, Planning, Governance and Decision Support
• Consult with lifecycle teams to provide decision analysis and other analytic and strategic support
• Support development of business cases for all investments/changes, including valuations
• Facilitate annual prioritization, goal setting, lifecycle planning and business planning processes
• Advise teams on internal governance processes associated with changes/new investments
• Strategic Projects at the TA Level and Cross-Portfolio
• Support development of molecule, pathway and disease area strategies
• Frame portfolio issues and conduct gap analyses to enable management to make informed and timely decisions, including corporate goal setting and portfolio optimization
• Facilitate TA level opportunity prioritization and strategic context
• Support partnering opportunities at the TA level
• Governance / Support for Late Stage Portfolio Committee
• Work with development teams to ensure that decisions go through appropriate governance
• Advise teams and stakeholders to ensure decisions are aligned with portfolio priorities

Job Skills and Expectations

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.

Clinical Specialist
NY Metro Territory

The Clinical Specialist, Franchise Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory in the Hospital/Critical Care setting. As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state.

Reports to: Division Manager, Franchise Sales

Example Duties and Responsibilities:
*Responsible for meeting or exceeding assigned sales targets
*Develops robust territory business plans
*Develops strong and long-term relationships with customers in all assigned accounts
*Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands
*Monitors operating costs and compliance with territory budget
*Complies with all laws, regulations and policies that govern the conduct of GNE activities
*Business travel, by air or car, is regularly required

Purpose:

* The CMO Logistics Specialist acts as a liaison between Manufacturing Collaborations (MC), the CMOs and Genentech’s plants and logistics functions and is responsible for the detailed scheduling of orders and material movements to and from contract manufacturing sites.

* The Logistics Specialist ensures that all materials are available and delivered to the CMO on time in order to support scheduled production and releases orders to allow the CMO (through the MC Site Managers) to execute and to close orders upon completion. 

* The Logistics Specialist monitors the detailed production and shipping schedule in order to identify and resolve any variances that are occurring and coordinate required changes with the CMO. He/she also follows up to identify root causes for such variances and the corrective actions required to prevent their reoccurrence.

* The Logistics Specialist provide support to the CMO with all issues related to logistics and inventory management and provide guidance for material handling and any other questions that arise.

* The Logistics Specialist is responsible to the accuracy of inventory records and status in Genentech’s ERP system for all GNE-owned material that is at the CMO site and works with the CMO to update these records as material movements/consumptions occur.

Responsibilities:

Ensuring material availability for CMO production:

* Perform material requirements planning for multiple sites

* Monitors the detailed production schedule at assigned CMOs to identify material requirements and other preparations required to ensure readiness for production execution

* Coordinates with supplying plants to ensure alignment and understanding of CMO material requirements and shipping dates

* Ensures material availability and/or that production/delivery plans at supplying plants/warehouses are aligned with material requirement and shipping dates

* Coordinates with Quality to ensure that material release/disposition plans are aligned with required shipping dates and monitor progress of release/disposition process relative to schedule and shipping requirements

Transportation scheduling and coordination:

* Creates, converts and maintains Stock Transfer Requests (STRs) and Orders (STOs) and/or Purchase Orders for required materials

* Coordinates and/or schedule shipments with carriers and/or GNE Transportation.

* Works with GNE Transportation Import/Export functions to ensure that international shipments are properly coordinated with freight forwarders or customs agents and that materials clear customs without issues

* Coordinates with warehouse and other logistics functions to ensure that materials are prepared and shipped on time

Logistics schedule management:

* Identifies any delays during the manufacturing/release process that may have an impact on the scheduled shipping dates and works with relevant functions to avoid delays to scheduled delivery dates to CMOs

* Identifies, analyzes and escalates (to Master Scheduler or manager) schedule conflicts or delays that impact delivery dates to CMO 

* Coordinates any required changes with CMO

* Monitors the shipping/transportation of materials to/from CMO sites to ensure successful and on-time delivery.

Materials management:

* Manages and releases process orders to ensure a minimum of 7 days of orders have been released.

* Performs goods receipts of materials into CMO inventory locations upon delivery and monitors CMO inventory and material movements to ensure accuracy

* Performs regular inventor counts with each CMO and ensure updates GNE inventory records if necessary

* Allocates materials to production orders (in coordination with product planners as necessary)

* Provides guidance to CMOs and addresses questions and issues related to material handling, inventory and transportation

Performance management and projects:

* Monitors Key Performance Indicators (KPI’s) and supports root-cause analysis

* Executes all logistics process and other responsibilities in accordance with established business processes

* Identifies areas where existing business processes are not sufficiently defined/documented and/or require improvement

* Works with management to initiate improvement projects to address process deficiencies or improvement opportunities

* Collaborates with various groups and OE resources while working on cross-functional teams to support improvement projects and root cause analyses

* Takes responsibility for action items and tasks arising through such cross-functional teams and root-cause-analysis exercises and executes them to accomplish the team’s objectives 

Level - E3/E4

Main Purpose of the Position:    
·         Solve a wide range of difficult Manufacturing Quality Assurance and Product Release issues that impact multiple functions following cGMP regulations and Genentech standards 
·         Perform assigned tasks and work to achieve company goals and department objectives.
 
Job Duties/Responsibilities: ·         Follow company policies and procedures.
·         Maintain a state of inspection readiness.
·         Provide input to the development of personal performance goals and departmental objectives.
·         Collaborate with Management to establish and meet targets and timelines.
·         Support routine operations and allocate assigned resources.
·         Manage competing priorities.
·         Serve as the Quality representative on cross-functional and multi-site teams.
·         Identify, design, and implement process and system improvements.
·         Lead and participate in the design and implementation of department and cross-functional initiatives.
·         Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems.
·         Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
·         Serve as a technical subject matter expert (SME) in support of department functions.
·         Train personnel and internal customers on relevant business processes.
·         Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
·         Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
·         Perform any other tasks as requested by Management to support Quality oversight activities.
 

Technical Duties/Responsibilities:
·         Manage the product disposition program in support of manufacturing operations.
·         Review and approve master batch production records.
·         Collaborate with departments to ensure product release activities are executed efficiently and effectively.
·         Review and approve lot release documentation.
·         Provide technical assessment for process changes that may impact product disposition.
·         Provide Quality oversight to internal and external customers.
·         Provide input into investigations with potential product, process, or material impact.
·         Ensure process and documentation discrepancies are identified, defined and assessed.
·         Recommend final product disposition impacted by a deviation or discrepancy to Senior Management.
·         Create and maintain a system for tracking, trending, and reporting discrepancies identified and assessed by MQA.
·         Develop a system for tracking, trending, and reporting product release cycle times.
·         Monitor MQA activities to evaluate trends, and report repetitive anomalies, observations, and discrepancies to Senior Management. 
·         Represent MQA at cross-functional meetings to develop, review, and approve Commercial Quality documents.
·         Participate in the MQA review audit program and the Raw Material Reconciliation process.
·         Present and provide rationale for the batch release program during periodic audits and regulatory inspections.
·         Prepare, review, and approve relevant sections of regulatory submissions.
·  &nb...

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.

Planning Lead, Access Solutions Responsibility & Accounting Quality and Compliance 

The candidate will need to live within the South San Francisco, California area. Relocation assistance will not be provided.

The Quality and Compliance Lead has an advanced knowledge base regarding Operational Quality and/or Healthcare Compliance and Privacy. This position is responsible assisting in the maintenance of all aspects of quality and general compliance within the Access Solutions Organization, keeping abreast of all healthcare and compliance ethics, and the management of external business partners. Additional key responsibilities of this role are: quality and compliance risk management, cross-functional and multilevel partnership, represents the Assess Solutions Organization as a subject matter expert on compliance related matters.

• Shares responsibility for monitoring, review and analysis of quality and general compliance for all Access Solutions operational entities. Relied upon for sound compliance guidance.
• Assists in the integration of quality and compliance risk/context and business knowledge to address complex problems; provide communications to business partners.  Keep current in the area of healthcare compliance and ethics. 
• Identify and address quality and compliance issues.
• Provide verbal and written communication to internal and external partners regarding clear and concise quality and compliance guidance and context.
• Deliver well organized presentations
• Assist in the management of outside consultants, vendors, etc., effectively for specific projects with moderate corporate impact within assigned budget guidelines
• With limited oversight, develop resolutions to complex compliance problems, impacted goals, and objectives of business partner groups.
• Act as a team member for quality/compliance issues/questions.  Represent Access on project teams, multi-disciplinary groups and peers for projects or contracts.
• Interact with business partners on compliance matters of low to medium risk.

The PD/PT Regulatory Affairs Informatics (FPPR) team is looking for a highly skilled Delivery Service Manager, who will support the Submission Management systems area.  This candidate will be able to deal with a diverse and multicultural, global team in varied time zones, who is proactive, outgoing and detail- oriented with excellent problem solving, and written/verbal communication skills.

Further responsibilities are:

• Applies complex procedures and defined standards to meet current business, customer and technical requirements and leads others in resolution of complex problems.
• Leads specialist resources on technical issues within the domain on content and provides detailed analysis of the operations and opportunities for improvement.
• Develops business/technical critical know-how within area of expertise for the function and is familiar with opinion leaders in the field. Assists in the development of others know-how by passing on knowledge of tools and techniques.
• Supports day to day operations and / or implementation of projects within area of technical expertise, contributes to the implementation planning and may execute some aspects of that plan. Accountable for roll-out of new services or enhancement to existing services.
• Manages incident and problem management processes, release and configuration management according to ITIL. This includes continuous improvement for the management of the services. Acts as the initial point of escalation for incident, problem and change management for the Business Representative (e.g. Business Lead)
• Administers change control procedure and processes. This includes the management of the change control board and oversight of the approved change
• Is well-versed in vendor management and can look for new opportunities to optimize our vendor contracts and relationships.
• Is familiar with Statement of Work (SOW) and procurement processes
• Is customer-focused and able to track problems/issues to their resolution with the appropriate level of follow-up to the user community
• Builds and maintains good working relationships with the Business Representative and the client business base , monitors services and providing regular service reports to the FPPR management and business clients

Medical Communications Scientist is able tocommunicate relevant, timely, accurate, and balanced clinical information onGenentech's products, positively influencing their safe and effective use.

DESCRIPTION:

The Medical Communications Scientist is able tocommunicate relevant, timely, accurate, and balanced clinical information onGenentech's products, positively influencing their safe and effective use. Ableto evaluate medical literature as well as write, review, edit, and approvemedical content to ensure appropriate clinical context and accuracy. Providesmedical responses through various communication channels (response documents,web-based media, scientific meetings, etc.). Is also able to provide trainingrelevant to Genentech's product portfolio. Has a basic understanding oflegal/regulatory topics adequate to describe the basis of Medical Affairspolicies and procedures, and applies this knowledge to the review ofpromotional materials and Medical Affairs documents.  The Medical Communications Scientist is able to assist in the development andimplementation of Medical Communication policies and procedures, establish andsupervise the work flow for delegated projects, and assess incoming requestinformation to determine required action and triage based on internal policiesand procedures. Can convey and acquire medical information as well ascommunicate and work effectively with members of the Medical Communicationsstaff and customers which include but are not limited to: Sales, Marketing,Managed Care, Clinical Development, Product Safety, Regulatory, Legal, andCorporate Partners.

Main Purpose of the Position:   
• Manage and develop solutions to complex global QC change control issues and Quality initiatives with inter-organizational and multi-site impact across the Biologics network following cGMP regulations and Roche standards. 
• Perform tasks and work to achieve company goals and organizational objectives.

Job Duties/Responsibilities:
• Follow company policies and procedures.
• Set personal performance goals and provide input to departmental objectives.
• Establish work priorities to meet targets and timelines.
• Manage competing priorities and allocate, adjust, and optimize assigned department resources.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Manage department and cross-functional initiatives.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Develop and train personnel and internal customers on relevant business processes.
• Mentor junior personnel serving as a subject matter expert (SME) on Quality systems, processes and issues.
• Collaborate and author department policies and procedures.
• Make decisions that impact the goals and objectives of the department.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. 
• Sign documents for activities as authorized and described by Roche policies, procedures and job descriptions.
• Be accountable for behaviors as described in Roche Leadership Competencies.
• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Manage the end to end change control process.
• Manage multi-site change control activities for the Biologic OU including but not limited to; Specifications, direct materials, validated systems, methods, qualified equipment, and controlled documents.
• Manage the Review and approve processes for changes. 
• Ensure system and process changes are reflected in appropriate procedures and controlled documents.
• Collaborate with internal departments and across sites to ensure understanding and execution of change control process and procedures.
• Facilitate and contribute to cross-site change management forums. 
• Develop and implement strategies for effectively managing multi-site changes 
• Lead change control process improvement activities
• Promote and provide guidance in Good Documentation Practices.
• Assist in developing training content and qualifications for change control processes and change management applications. 
• Serve as a resource for Change Control knowledge management across site Quality departments.  
• Collaborate with Quality departments in the administration, access, and communication of the Change Control system.
• Manage Record Management and Record Retention program activities and processes.
• Manage the centralized records repository.
• Collaborate with Operational and Quality departments to maintain GMP records.
• Provide metrics and reporting as needed.

This position is for Swing shift (Monday – Friday 2:00pm – 10:30pm).

Main Purpose of the Position:   

• Solve a variety of routine and difficult Manufacturing Quality Assurance and product release issues following cGMP regulations and Genentech standards       
• Perform assigned tasks and work to achieve company goals and department objectives. 

Job Duties/Responsibilities:

·               Follow company policies and procedures.

·               Maintain a state of inspection readiness.

·               Provide input to the development of personal performance goals and departmental objectives.

·               Collaborate with Management to establish and meet targets and timelines.

·               Independently manage competing priorities with limited instruction.

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

·               Identify and recommend solutions to potential procedure, process and system gaps.

·               Provide assistance to customers in support of departmental functions.

·               Participate in the design and implementation of department and cross-functional initiatives.

·               Apply basic theory and technical principles to address moderately complex problems.     

·               Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

·               Serve as a technical subject matter expert (SME) in support of department functions.

·               Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.       

·               Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.

·               Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:

·               Evaluate and close complex, non-investigational discrepancies.       

·               Initiate discrepancy investigations as required.       

·               Draft and route discrepancy summaries to Discrepancy Management.         

·               Perform Assessor and Evaluation activities defined in the Discrepancy Management System (DM...

The Clinical Specialist, Franchise Sales manages anddevelops long-term relationships with physicians and other customers for thecustomer accounts in the assigned territory. As such, Clinical Specialists represent the assigned GNE brand(s) andtheir approved indications; helping external customers such as physicians,nurses, etc. learn about the benefits of the assigned GNE brand(s) in relationto the applicable therapeutic area/disease state.

Reports to: Division Manager, Franchise Sales

Example Duties andResponsibilities:

*Responsible for meeting or exceeding assigned sales targets

*Develops robust territory business plans

*Develops strong and long-term relationships with customersin all assigned accounts

*Presents the assigned GNE brands in a professional,compliant, ethical and effective manner; helping external customers understandthe benefits and use of GNE brands

*Monitors operating costs and compliance with territorybudget

*Complies with all laws, regulations and policies thatgovern the conduct of GNE activities

*Business travel, by air or car, is regularly required 

• Close collaboration/partnership with the PD Operational staff
• Facilitation of subject matter experts within and outside PDG
• Strategic liaison with PDQ (global quality group)
• Staying abreast of internal and external developments, trends and other dynamics relevant to the quality and efficiency of PDG

• Continuous Improvement
• Training Compliance
• Facilitating simple aligned business processes
• Inspection Readiness and supporting Sponsor inspections
• Lead and/or supervise other key projects as required

Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, Program Directors are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Program Directors provide regulatory leadership for one or more regional or global development projects. Regulatory Program Management Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Program Directors are expected to lead more complex projects and represent PDR to cross-functional teams and groups with increased independence. Regulatory Program Management Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners.  Regulatory Program Management Program Directors serve as the principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions.

DUTIES & RESPONSIBILITIES:

• Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.  Briefs teams and management, as appropriate
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
• Provides regulatory expertise and leadership to site, regional or global cross-functional teams and other groups
• Stays abreast of therapeutic area product development and other related business strategies and plans 
• Serves as the primary PDR representative on one or more regional or global projects at any one point in time; typically complex projects
• Analyzes data, the regulatory environment and business objectives to recommend priorities
• Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment.  Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators and Roche
• Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development
• Identifies and aligns cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
• Works with others to ensure timely and appropriate cross-functional alignment and appointment to RAFT for each assigned project
• Presents and obtains approvals for the cross-functional regulatory strategy to various teams, committees and senior management
• Serves as the site, regional or global principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site, regional and/or global teams
• Provides internal teams with direction on regulatory authority interactions
• Manages ongoing RAFT meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters.  Manages RAFT resources
• Ensures cross-functional perspectives and expertise are incorporated into regulatory plans prior to decisions being made
• Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary 
• Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation
• Responsible to ensure all PDR deliverables associated with each project or other assignment are completed within defined timelines and meet...