Purpose:
• Solve a wide range of difficult validation activities and quality issues that impact multiple functions following cGMP regulations and company standards.
• Identify gaps and declining trends as well as innovate on processes and tools to simplify work and standardize practices.
• Build relationships and teamwork across departments, functions, and organizations to ensure commitment and adherence to PTQ strategies and initiatives.
• Be open-minded to diversity in people and ideas and be customer focused without sacrificing quality.
• Perform assigned tasks and work to achieve company goals and department objectives.

Accountabilities:
• Innovate and develop tools and processes to improve standard work and efficiencies.
• Build relationships to influence and dissimulate PTQ strategies, processes, and initiatives.
• Proactively identify gaps and trends in quality and compliance in order to proactive prevent decrease in compliance for inspections.
• Be open to diverse opinions, ideas, and viewpoints to be in a position to make the best decisions, plan, and executions.
• Balance between customer service and compliance without sacrificing quality standards and quality of work.
• Establish and follow company policies and procedures.
• Maintain a state of inspection readiness.
• Provide input to the development of personal performance goals and departmental objectives.
• Establish work priorities to meet targets and timelines.
• Manage competing priorities and allocate, adjust, and optimize assigned resources when applicable.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Development and 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 on and author department policies or guidelines.
• 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.
• Be accountable for behaviors as described in companies Core, Common, and Critical Competencies.
• Perform any other tasks as requested by Management to support quality oversight activities

Requirements:
• Process Chance Requests related to accountable computer systems.
• Determine Change level per quality policies and appropriate training.
• Review, assess and approve IT related changes.
• Collaborate with departments to ensure validation activities are executed efficiently and effectively.
• Provide guidance to internal and external customers on best practices for executing and maintaining a validation program.
• Develop strategies for new validation projects in collaboration with system owners.
• Develop near-term and long-range plans for the group in collaboration with Management.
• Review and approve applicable validation deliverables.
• Collaborate with departments to ensure validation activities are executed efficiently and effectively.
• Present and provide rationale for the validation strategies during internal and external audits.
• Ensure the department is represented on relevant project teams.
• Identify, design, and implement validation process improvements.
• Support internal and external audits.
• Assist senior personnel in support of regulatory inspections
• B.A. or B.S degree (preferably in Life Science or Engineering) and at least ten years experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience
• Sound knowledge of cGMPs or equivalent regulations
• Ability to interpret and relate quality Standards for implementation and review
• Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
• Ability to communicate clearly and professionally both in writing and verbally
• Flexibility in problem solving, providing direction and work hours to meet business...

This position may be filled at a Strategy Manager or Sr. Strategy Manager  level.

Strategy Manager/Senior Strategy Managers in Managed Care Marketing develop, implement and manage the managed care marketing strategy, plan and tactics. Managed Care Marketing directly supports Genentech’s business by ensuring managed care marketing strategies, plans and tactics enable business, financial and operational goals, targets and objectives to be met or exceeded across managed care segments within the U.S. Senior Product Managers act as a primary liaison to managed care account management and may also have matrix responsibilities to represent Managed Care Marketing for one or more products or franchises, as assigned.

• Stays abreast of and continuously develops his/her knowledge regarding internal and external business developments and drivers. Includes in-depth knowledge of the current and evolving managed care landscape and its implications for Genentech -  formulary positioning, reimbursement, access and overall market share
• Conducts and synthesizes managed care markets landscape surveillance into commercial and market impact
• Provides analytic support for Government Affairs and Industry Analytics; including identification of commercial implications of legislation to support lobbying and forecasting
• Translates implications of reform and other legislation to Genentech’s go-to-market approach; including development and execution of Genentech’s Value Forum
• Responsible for educating internal partners and stakeholders regarding the managed care landscape in the U.S. and related territories and implications of such to current, medium- and longer-term managed care marketing strategies, plans and objectives
• Reviews and assesses cross-functional business strategies, plans and tactics.  Influences decision-making regarding Commercial-wide patient access-related issues
• Contributes new creative, innovative opportunities; increasing adoption, pull-through and overall financial results
• Responsible for expertly creating and managing 3-year and 1-year managed care marketing strategies, plans, and tactics.  May also be, as assigned, responsible for Reimbursement Outlook
• Works closely with cross-functional teams to align therapeutic area and managed care marketing strategies, plans and tactics with pricing, reimbursement, contracting, distribution and other relevant business, financial and operational strategies, plans and objectives 
• Contributes expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans
• Works with MCCO account management teams to develop and communicate the managed care marketing strategy. Works similarly with MCCO’s field reimbursement account management teams to develop and communicate the managed care practice management strategy for physicians and other healthcare professionals in the field
•  Works with cross-functional groups to ensure a seamless and well-integrated message and overall positioning across multiple marketing platforms, e.g., online, direct-to-patient, etc.
• Creates appropriate marketing budgets by working with peers, manager and/or other internal partners
• Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility
• Continuously monitors and measures effectiveness and results from managed care marketing strategies, plans and objectives. Regularly reviews forecasting and other business analyses and uses to make appropriate further recommendations to increase market access, address currently unmet needs, and generally help to improve the overall market strength for Genentech in assigned managed care segments
• Directly manages the implementation of all assigned managed care marketing plans and tactics to ensure timely and quality execution that will meet or exceed assigned targets, goals and objectives
• Works with others to identify, recommend, create and help implement new account management tools/resources that will enable the field to represent Genentech in accordance with the defined strategy and position
• Executes a number of strategic projects and develops internal points-of-view (POVs)
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

Lead the development of pharmaceutical manufacturing processes or technologies on bench & pilot scale and implementation on a manufacturing scale. Collaborate across multiple functional areas such as formulation development, manufacturing and validation. Utilize advanced engineering principles, concepts and techniques to solve technical problems in the following areas of focus: storage / handling of protein bulks, freezing, thawing, mixing, sterile filtration, filling, pre-filled syringes, microencapsulation, lyophilization, vial inspection and/or terminal sterilization by radiation, vaporized hydrogen peroxide, or other gases. Support or lead technical projects and on-going manufacturing operations including technical transfers between sites and performing trouble shooting activities. Managerial responsibilities commensurate with experience.

Description

Management Associate, U.S. Commercial Services

Reporting to the Head of U.S. Commercial Services, the Management

Associate will provide high-level administrative support to the Head and leadership team members of the U.S. Commercial Services department.

Job Description:

The Management Associate supports the assigned executive and team (as appropriate) with a variety of group administration and operational activities.

Example Duties and Responsibilities:

- Acts as the departmental "go-to-person" for general operational or administrative questions or Genentech policies U.S. Commercial Services guidelines or other inquiries. There is a strong emphasis on organization and proactive coordination of activities.  

- Complex calendar management including meeting scheduling and resolution of scheduling conflicts

- Frequent interaction and planning with executive-level assistants and their customers

- Manage, plan and execute on key project support for management team, including representing company to wide range of partners and outside vendors

- Provide general administrative and clerical support to all areas in U.S. Commercial Services, as required

- Participate, plan, coordinate and prioritize work within or across teams' in support of department projects and goals using independent judgment and initiative

- Attend and actively participate at staff level meetings as required, coordinate/publish agenda and meeting minutes

- Address problems and develop practical, thorough, and creative solutions 

- Independently create and deliver communications based on general instructions

- Generate, disseminate and maintain departmental documents and information

- Administer and contribute content for the department's communication platforms, including portals, newsletters, and announcements

- Coordinate, schedule and execute departmental off-sites, team meetings, and activities, including cross-functional meetings or events

- Manage deadlines related to business planning as well as other special projects

- Develop, implement and evaluate department work processes and procedures 

- Collaborate with Admin team to support complex projects and deadlines

- Proactively assess travel needs and plans and propose arrangements

- Coordinate, monitor and track department contracts and PO's

- Schedule candidates for open positions within the department 

- Actively participate in the on-boarding of new hires

- Exercise independent judgment and discretion of sensitive/confidential and proprietary 

information

- Actively participate in Global Pharma Procurement and Commercial activities

- Ensure compliance with Genentech policies and guidelines in all endeavor

Main Purpose of the Position:
• Supervise and develop staff completing Change Control activities and drive resolution of complex change control issues following cGMP regulations and Genentech standards. 
• Supervise performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment.

Job Duties/Responsibilities:
• Manage and administer all aspects of people processes related to the employee lifecycle.  This includes the selection, hiring and training of personnel on company and department policies, systems and processes.  Manage and communicate compensation related information per company guidelines.
• Coach and develop staff by providing an environment that encourages ongoing personal and professional development.  Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year.  Ensure staff receives appropriate knowledge and skill development and growth opportunities.
• Determine and communicate objectives and accountabilities for direct reports.
• Regularly review staff progress in meeting objectives.
• Recommend improvements to Quality operational policies, plans and procedures.
• Ensure activities are completed on time and issues resolved within budget.
• Make recommendations to department budget and staffing needs.
• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Participate in continuous improvement initiatives for Genentech Quality Systems.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Oversee the impact assessment of proposed changes and ensure appropriate approvers are selected for changes.
• Supervise change control activities for validated systems, qualified equipment, and controlled documents.
• Participate in cross-site change management forums. 
• Supervise staff conducting change control activities for quality and business systems support in GMP areas. 
• Participate in business process improvement programs and process redesign initiatives.
• Promote and provide guidance in Good Documentation Practices. 
• Supervise lot release restrictions imposed by system, process, method and equipment changes.
• Ensure the completion of required actions prior to lifting lot release restrictions. 
• Assist in developing training content and qualifications for change control processes and change management applications. 
• Act as a resource for Change Control knowledge management within Quality Operations and across site Quality departments.  
• Collaborate with site Quality and Production units in the administration, access, and communication of the Change Control system.
• Participate in change control automation and business process improvement initiatives. 
• Supervise Record Management, Retention and Repository program activities and processes.
• Collaborate with Quality and Production departments to maintain GMP records.
• Ensure backup and disaster recovery system activities are implemented and maintained for critical GMP records. 
• Ensure data integrity and recoverability of electronic GMP records according to Genentech policy.

The Position: Accountable for managing a multi-discipline technical group responsible for performing a variety of routine and complex activities under cGMP regulations and standards. The team’s primary responsible is providing technical support for downstream manufacturing operations to ensure reliable delivery of drug substances to the global supply chain. Manage performance and development of direct reports to achieve organizational and department goals in a productive work environment. Develop solutions to complex issues and key Technology initiatives. Establish work priorities and timelines in alignment with project and department needs. Form productive relationships with individuals and groups across the Vacaville site including but not be limited to; Manufacturing, Science and Engineering groups, Validation, Facilities, and Quality Assurance.

Responsibilities and Job Duties: The successful candidate will manage and administer all aspects of personnel performance and staff development. This includes selection, hiring, and training of personnel on company and department policies, systems, and processes. Manage and communicate compensation related information per company guidelines. Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year, including workload balancing. Recommend and implement improvements to Technology policies, plans, and procedures. Manage routine department activities and Technology initiatives, ensuring completion of activities and initiatives on time and within budget. Serve as downstream frontline representative on cross-functional teams and at senior level meetings. Oversee and direct timely resolution of complex issues through effective interdepartmental and cross-functional partnerships. Clearly and effectively communicate and present complex ideas and concepts to all levels within the company. Establish and communicate strategy, vision and direction for their team.

Technical Responsibilities: The successful candidate will be responsible for managing a diverse team comprising a variety of technical disciplines and skills levels, including Automation, Manufacturing Sciences, Process Engineering, and Validation.  The candidate will oversee technical cross-training efforts, act as a mentor, and provide technical career guidance. Provide technical leadership while fostering teamwork in a GMP environment across functional and organizational boundaries. Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution. The candidate must effectively manage their team in the following areas;

·        Immediate resolution of emergent issues including troubleshooting process, equipment and system malfunctions or failures on a 24/7 basis. Daily process monitoring and analysis of manufacturing data, support for discrepancy investigations, and identification/implementation of immediate corrective or preventative actions to ensure continued compliant operation.

·        Support and/or lead identification and implementation of near and long term changes including; analyzing and solving process performance problems, root cause analysis, and ownership/sponsorship of CAPAs. Support and/or lead a variety of capital and expense projects ranging from design, implementation, and startup. Develop solutions to complex problems which may require highly innovative and ingenious approaches.

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...

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

• Representation of DMPK at interdisciplinary project teams
• Pharmacokinetic data analysis and modeling
• Set-up and validation of in vivo ADME/PK models

POSITION:

Finance Manager (G&A Finance)

Reporting to the Associate Director, G&A Finance, the Finance Manager will provide strategic and traditional finance support to the Workplace Effectiveness, EHS and Security groups within the Site Services organization.  Workplace Effectiveness includes Genentech Real Estate, Workplace Planning, and SSF Site Engineering.  The role will interface with key stakeholders within Site Services, Finance, and other areas within the Genentech/Roche organization.

JOB DESCRIPTION:

Manage and coordinate planning deliverables to meet corporate objectives and deadlines. This includes annual budget, quarterly forecasts, the 5 Year & 10 Year Business Plans 

• 
  
• Manage the month/quarter end close processes including journal entries, accruals, account reconciliations, reporting, detailed variance analysis of results
• Member of the Workplace Effectiveness Forum - provide financial and non-financial support to assist in strategic decision making
• Build and maintain effective and collaborative business partnership between the Finance team and Workplace Effectiveness stakeholders
• Proactively identify, design, and implement enhancements to existing processes
• Propose and implement innovative solutions to complex business issues through ad hoc analyses
• Effectively communicate financial information with all levels of the organization, including senior management

Senior Project Manager – IT

The Senior IT Project Management position will be responsible for leading the delivery of technology projects in support of US Commercial Operations. The Senior IT Project Manager is accountable for the successful delivery of technical solutions through effective planning and execution throughout all phases of our project management methodology. The Senior IT Project Manager will be responsible for managing assigned resources, effectively tracking budgets and financial forecasts, creating and tracking detailed project plans, effectively leading and facilitating project meetings as well as proactively controlling project scope, risks and issues. This position is expected to provide timely status reports to all stakeholders and escalate issues to the appropriate management level. The Senior IT Project Manager will be accountable for all projects in the Commercial Compliance Solutions portfolio, either through direct management of projects or by sourcing and overseeing contract Project Managers. 

Duties:

* Define, plan, and direct the execution of a broad range of technical projects, while balancing the competing demands of scope, time, cost, quality, resources, and risk

* Identify, acquire, and lead multifunctional project teams

* Manage a portfolio of projects, in addition to individual projects assigned to the position

* Ensure project objectives/requirements are clear and agreed to by all stakeholders

* Manage relationships with various technology and business communities to achieve 

project objectives

* Facilitate project management activities across the entire project management methodology

* Establishes and maintains effective communication for assigned projects and with dependent projects

* Ensure successful and timely completion of deliverables

* Track progress against baseline schedule

* Plan, baseline and control costs to ensure projects are completed within approved budget

* Identify and apply systematic quality activities to ensure that projects employ all 

processes needed to meet Computer System Validation directives

* Suggest improvements where necessary / appropriate to improve operational efficiencies

* Conduct risk management planning, identification, analysis and monitoring on projects

* Formulate risk mitigation strategies and recommend solutions

* Manage the processes required to ensure timely and appropriate generation, collection, distribution, storage, retrieval, and ultimate disposition of project information and documentation necessary for successful communications across all stakeholders and any required updates to living system documents for validated systems

* Other duties as assigned

Job Purpose:

The IT Business Systems Analyst (BSA) position in the Patient & Physician Solutions team will be responsible for the delivery of technology capabilities for the Access Solutions organization in the US, which provides services to help people access Genentech medicines for a range serious conditions. The IT BSA will work on multiple projects for both internally-facing case management tools and externally facing web-based solutions serving physicians and patients, and will be accountable for understanding the needs of customers, developing effective user-friendly designs to meet those needs, and delivering detailed requirements and specifications to drive the development, testing, deployment and production support of IT systems.  

Primary Responsibilities:

The IT Business System Analyst (BSA) will drive the successful delivery of technical solutions through effective planning and execution throughout all phases of our project management methodology, which can follow either a traditional “waterfall” path or an “agile” path.   The IT BSA will assist in determining which methodology path will be most likely to ensure a successful delivery.  The BSA will be responsible for building deep understanding of processes used by medical practices and internal case managers to serve patients, and for integrating the knowledge into the design and delivery of tools to serve all users.  The IT BSA will establish themselves as a “thought partner” with internal customers.   The IT BSA will assure smooth integration with key partners leading the development, testing, training, communication and deployment of technology across the country, keeping management apprised of developments through clear and timely communication.  

Specific responsibilities include: 

• Collaborate with Project Managers, Architects, Engineers, Developers, User Experience Designers and Software Quality Assurance on scope, solutions, constraints, and risks 
• Analyze/document current and future business process models 
• Analyze/document high-level requirements (scope) 
• Analyze/document detailed functional requirements and business rules (use cases) 
• Analyze/document data requirements (from business needs perspective) 
• Support planning of user acceptance test (UAT), including creation of UAT scripts 
• Perform knowledge transfer to training and communication teams and support user deployment activities as needed
• Lead business stakeholders and other business systems analysts thru the business analysis lifecycle

The Position

The IT Project Management position in the Patient & Physician Solutions team will be responsible for leading the delivery of technology projects in support of the Access Solutions in the US, which provides services to help people get access to Genentech medicines for a range of serious conditions.  The IT Project Manager is accountable for the successful delivery of technical solutions through effective planning and execution throughout all phases of our project management methodology, which can follow either a traditional “waterfall” path or an “agile” path. The IT Project Manager will be responsible for supervising work by the assigned resources, effectively tracking budgets and financial forecasts, creating and tracking detailed project plans, effectively leading and facilitating project meetings as well as proactively controlling project scope, risks and issues. This position is expected to provide timely status reports to all stakeholders and escalate issues to the appropriate management level. The IT Project Manager will be accountable for projects in the Patient and Physician portfolio, either through direct management of projects or by sourcing and overseeing contract Project Managers.

Primary Responsibilities:

• Define, plan, and direct the execution of technical projects, balancing the competing demands of scope, time, cost, quality, resources, and risk
• Identify, acquire, and lead multifunctional project teams
• Manage multiple projects, in addition to individual projects assigned to the position
• Ensure project objectives/requirements are clear and agreed to by all stakeholders
• Manage relationships with various technology and business communities to achieve project objectives
• Facilitate project management activities across the entire project management methodology
• Establishes and maintains effective communication for assigned projects and with dependent projects
• Ensure successful and timely completion of deliverables
• Track progress against baseline schedule
• Plan, baseline and control costs to ensure projects are completed within approved budget
• Identify and apply systematic quality activities to ensure that projects employ all processes needed to meet relevant Computer System Validation directives
• Suggest improvements where necessary / appropriate to improve operational efficiencies
• Conduct risk management planning, identification, analysis and monitoring on projects
• Formulate risk mitigation strategies and recommend solutions
• Manage the processes required to ensure timely and appropriate generation, collection, distribution, storage, retrieval, and ultimate disposition of project information and documentation necessary for successful communications across all stakeholders and any required updates to living system documents for validated systems
• Assign and supervise project activities to the team leads and team members.  Communicate and coordinate assignment and resource-related issues to Genentech management and resource vendor representatives.
• Other duties as assigned

Description
The Critical Reagents System (CritRS) in Purification Development is responsible for the purification of critical reagents in support of assay development (for clinical products), assays in support of regulatory filings, the continued support of assays for marketed products, as well as specific reagents that support general test procedures (such as ELISAs to measure host cell impurities).  The candidate will be responsible for protein purification, characterization, and documentation of critical reagent production within the purification group. The work also includes interaction and collaboration with members of other CritRS production and customer groups, and potential support of other projects within the group.

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

Overview:

The Sales Operations Manager role is to support the assigned business unit or franchise with regular and ad hoc business analysis and reporting of, for example, product sales, market share, market segmentation, reimbursement analysis, and/or other measures of business performance. They work closely with other team members in Sales Operations & Information Management, helping to ensure data quality, accuracy, timely and targeted reporting, optimized database and other information systems operations, which may include regular responsibilities to support ongoing operational management of the sales force automation/customer relationship management systems and processes. They also provide the assigned group with support in customer targeting, field workforce sizing, structuring and territory alignments, sales goal modeling and allocation, sales incentive compensation plan design, and/or payment distributions and administration. Given the nature of this role, they work regularly with cross-functional customers in the

assigned business unit or functional unit, such as Franchise Sales and Marketing, as well as a host of other internal partners and stakeholders, including Market Analysis & Strategy, gCOI (Genentech's Corporate Office of Information Technology), and others.

Key Responsibilities

• Primarily responsible for managing and training on all sales operations deliverables including operations launch planning, analytics, reporting, targeting, alignments, Incentive Compensation and Sales Force Automation for their assigned brand(s)
• Partner with sales management and Field Sales Operations to define and produce analytics that support the business objectives and strategies. Provide periodic reports and detailed analysis to identify drivers behind trends and potential business opportunities
• Develop communication materials to support field sales management on business reviews and sales force tools
• Support and respond to field sales inquiries around data
• Collaborate in the management of all IC operation activities including goal allocation, goal adjustments, IC reports. Partner with Compensation Administration team to validate and process incentive payouts, assess and provide impact on issues affecting field incentive plan
• Collaborate with the Information Technology team to define business requirements and solutions for all tools and deliverables that support the field sales force
• Comply with all laws, regulations and policies that govern the conduct of GNE activities