Product Manager / Sr. Product Manager – Managed Markets Launch Strategy, Growth Disorders

This position is in the Managed Markets Launch Strategy group within Managed Care Marketing (MCM). MCM supports Genentech’s business by designing managed care marketing strategies, plans and tactics that enable Genentech’s goals to be met across US managed care segments (payers, channels, practices). Managed Markets Launch Strategy develops, implements and manages the managed markets marketing strategy, plan and tactics for Genentech’s pipeline. The team supports molecules as early as Phase II drug development, and involvement extends to approximately 6 months post-launch.

PM/SPMs in the Managed Markets Launch Strategy group are generally responsible for multiple molecules at various stages of development. This opening would be primarily focused on leading launch preparations for a compound treating a growth disorder, which could represent a significant advance for patients.

Key activities for this role include:

• Execution of Managed Care Marketing deliverables for product launches. Builds, implements and manages the managed care marketing launch plans, including market readiness activities, launch readiness reviews, account segmentation, key message development, promotional development, field training, and competitive readiness (if relevant for pipeline products).  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. Creates and manages appropriate marketing budgets. Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility
• Coordination of overall Managed Care and Customer Operations (MCCO) pre-launch activities. Leads MCCO launch team to drive cross-functional alignment and support creation of strategies, plans and activities that support optimal formulary positioning, reimbursement, access and overall market share. Provides managed care perspective to Brand and other partners, participates in Brand-led launch core team, launch readiness reviews, leadership updates, etc.
• Strategic planning for relevant molecules to contribute to Phase III drug development investment decisions, trial design, and overall value proposition. 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. US and Global cross-functional partners include brand marketing, health economics, pricing & contracting, market planning, competitive intelligence and government affairs
• Expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans. Participation in US Commercial pipeline and launch teams as well as international payer strategy teams (IPSTs)
• Contribution to creating a center of excellence for launching new molecular entities (NMEs) and line extensions, where appropriate, in managed markets, by consolidating all pipeline activities into one group
• Compliance with all laws, regulations and policies that govern the conduct of GNE activities
  

CORA 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. CORA Program Directors chair moderate to higher complexity Promotional Review Committees (PRCs), for different products and product development phases, as business needs dictate. CORA Program Directors are responsible for leading and managing the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion for Roche pharmaceutical products and devices. Associate Program Directors are expected to perform their responsibilities with increased independence. 

Intact & Cross-Functional Teams:

• Participates in site, regional and/or global CORA departmental meetings 
• Leads assigned PRCs
• As appropriate, participates as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products. Represents CORA and supports effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution

Commercial Regulatory Affairs:

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for Roche therapeutic areas and products. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics 
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices 
• Maintains current awareness of evolving health authority interpretations; including advisory letters, enforcement letters and policy issues.  Communicates significant changes or other relevant matters to internal partners and stakeholders 
• Facilitates the timely development and approval of disease state and promotional materials by interpreting and applying regulations and guidelines from health authorities and Roche policies 
• Manages the development of relevant correspondence with health authorities and interpretation of health authority comments, as well as serving as the primary Roche liaison with relevant personnel in marketing, advertising and communication offices within health authorities 
• Chairs PRC meetings and effectively collaborates with cross-functional internal groups and external advertising agencies 
• Participates in commercial meetings to provide a regulatory perspective on marketing strategies, implementation and promotion objectives 
• Develops and implements effective strategies for health authority marketing, advertising and communications submissions 

Note: Position can be filled as a QC Pharmaceutical Specialist II (E4) or Sr. QC Pharmaceutical Specialist (E5) based on education and experience.

QC Pharmaceutical Specialist II Role
The QC Pharmaceutical Specialist is a member of the senior technical staff of the QC Microbiology/Environmental/Molecular team specializing in microbiological challenge studies (i.e. disinfectant efficacy testing, antimicrobial effectiveness), sterility testing method and isolator validation, as well as deviation assessment/management.

Main Purpose of the Position:   
• Develop solutions to complex Quality Control testing activities and issues and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech 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.
• Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
• 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.
• Meets scheduled performance of 95% on time.
• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Provide technical expertise in the development of test method validation protocols and supporting procedures.
• Ensure validated methods and supporting procedures adhere to approved regulatory specifications.
• Prepare validation summary reports for test method validation activities.
• Provide input into regulatory filings.
• Perform Quality Control testing for product release and stability samples.
• Support quality investigations for testing and test method discrepancies.
• Perform equipment validation for laboratory instruments used in cGMP testing activities.
• Provide input into the generation of stability study protocols.
• Collaborate with departments to ensure product release and stability testing requirements are completed.
• Communicate testing or scheduling issues that may impact the timely release of final product to Quality Control Management.
• Compile trending reports for method validation and testing activities.
• Develop and deliver training materials for new and revised test methods and laboratory procedures.

Job Description:

A position is available for a Scientist / Senior Engineer (E4) in the Purification Development department. The successful candidate will support the development and implementation of recombinant protein purification processes from laboratory to manufacturing scale.  This will include process optimization and product characterization as well the support of high throughput experiments and lab automation activities within the Purification Development department.  Activities will include the development of homogenization, centrifugation, chromatography & filtration operations, analytical methods such as electrophoresis and HPLC and the design and execution of high throughput experiments using robotic systems.

Product Manager or Sr. Product Manager - Launch Strategy - Bio-Oncology 

This position is in the Managed Markets Launch Strategy group within Managed Care Marketing (MCM). MCM supports Genentech’s business by designing managed care marketing strategies, plans and tactics that enable Genentech’s goals to be met across US managed care segments (payers, channels, practices). Managed Markets Launch Strategy develops, implements and manages the managed markets marketing strategy, plan and tactics for Genentech’s pipeline. The team supports molecules as early as Phase II drug development, and involvement extends to approximately 6 months post-launch. Each Senior Product Manager has the opportunity to work on molecules at various stages of development.

Key activities for this role include:

• Representation of Managed Care Marketing in product launches. Builds, implements and manages the managed care marketing launch plans, including market readiness activities, launch readiness reviews, account segmentation, key message development, promotional development, field training, and competitive readiness (if relevant for pipeline products).  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. Creates and manages appropriate marketing budgets. Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility
• Coordination of overall Managed Care and Customer Operations (MCCO) pre-launch activities. Leads MCCO launch team to drive cross-functional alignment and support creation of strategies, plans and activities that support optimal formulary positioning, reimbursement, access and overall market share. Provides managed care perspective to Brand and other partners, participates in Brand-led launch core team, launch readiness reviews, leadership updates, etc
• Strategic planning for relevant molecules to contribute to Phase III drug development investment decisions, trial design, and overall value proposition. 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. US and Global cross-functional partners include health economics, pricing & contracting, market planning, competitive intelligence and government affairs
• Expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans. Participation in US Commercial pipeline and launch teams as well as international payer strategy teams (IPSTs)
• Contribution to creating a center of excellence for launching new molecular entities (NMEs) and line extensions, where appropriate, in managed markets, by consolidating all pipeline activities into one group
• Compliance with all laws, regulations and policies that govern the conduct of GNE activities
  

Associate Calculations Manager

Associate Calculations Managers support the calculation of complex government pricing calculations to determine government pricing in accordance with strict accuracy targets, timelines, laws, regulations and Government Pricing & Reporting’s (GP) methodology. Associate Calculations Managers also support the peer review process and are responsible for supporting government contracting.

• Acts as a subject matter expert on government contracting, pricing, pricing calculations and reporting
• Participates in the development, education, communication, implementation and ongoing maintenance of Government Calculations Standard Operating Procedures (SOPs), systems, processes, data, reporting templates and the like. Supports development and maintenance of effective GP systems; including suggesting business requirements, potential enhancements and, when applicable, supporting testing processes for new or updated systems
• Creates and implements standard reports
• Supports development and implementation of Government Calculations-specific training; including conducting training for other staff members
• Responsible for ongoing and consistent adherence to all applicable laws, regulations, corporate and business unit standards  Develops and cultivates professional relationships internally and externally
•  Ensures proactive and regular communication with internal and external partners/stakeholders
• Administers federal government contracting; including IFF, VMI and FSS
• Performs assigned government calculations to ensure timely and accurate completion; including monthly and quarterly AMP, BP, ASP, NFAMP/FCP, PHS and state reporting
• As assigned, supports BP restatement processes
• Validates accuracy of calculations for appropriate government pricing
• Enters relevant data and information into respective departmental/company systems and databases
• Ensures pricing calculations are routed through to appropriate stakeholders and partners for further review, approval and processing  
• Collaborates with Finance and others to reconcile monthly direct sales following prescribed guidelines and timelines; ensuring that any data integrity issues are resolved prior to beginning government pricing calculations
• Prepares and delivers monthly/quarterly data submissions to various internal and external parties, such as government agencies, to meet all compliance and reporting requirements
• Prepares, obtains approval for and ultimately publishes various departmental scorecard reports, customer business review reports, various compliance and other ad hoc reports
• Responds to questions/inquiries regarding assigned government programs and payers
• Reviews the work of less experienced staff members and coaches them on how to administer government contracts, perform and validate government calculations; including explaining SOPs and other requirements
• Supports internal and external audits
• May train and educate others outside of the department in departmental systems, processes, data, reports and the like
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

Associate Group Manager, Government Calculations

The Associate Group Manager, Government Calculations leads and oversees the function and specialist team of calculations managers who process all Government Pricing & Reporting (GP)-related calculations and are accountable for compliance with strict accuracy targets, timelines, laws, regulations, government contracts and GP’s methodology. In addition, the Associate Group Manager is responsible for effective deployment of and improvements to GP Standard Operating Procedures (SOPs), systems, technologies, and data. The Associate Group Manager regularly engages with relevant partners and stakeholders to resolve operational issues. He/she may also lead cross-functional projects from a GP calculations, systems, process or data perspective.

• Acts as the subject matter expert for content and interpretation of various, often complex, government programs, contract strategies, contract issues or terms, e.g. pricing and payment calculations, contract performance, compliance, etc.
• Proactively reviews and assesses existing government programs, contracts, contract administration practices, policies, guidelines, systems, performance tools, etc. versus new, extended or enhanced opportunities. Plays a leadership role in recommending new opportunities; including leading in the development and implementation of such
• In conjunction with Managed Care Contracts Manager, collaborates with the renewal of Federal Supply Schedule Contract
•  Plays a leadership role in GP-wide annual and longer-range strategic and tactical planning
• Leads Government Calculations input into GP annual and longer-range strategic and tactical plans. Includes developing and recommending budget requirements for the work of Government Calculations
• Coordinates with Government Analytics & Compliance on stakeholder meetings and planning initiatives. Provides expert recommendations and perspective to ensure, from the government contracting process and calculations perspectives, effective and efficient policies and contracting strategies
• Develops and cultivates professional relationships internally and externally; including external vendor partners supporting or otherwise involved in work relevant to Government Calculations
• Works with Legal, Government Analytics & Compliance and other groups to evaluate legal and regulatory requirements with government payer pricing and contracting strategies to ensure full and exacting alignment and compliance for Genentech; including all relevant government contracting and calculations processes, monitoring and reporting practices, systems, data and other tools
•  Supports as needed, or otherwise participates in the development of new, enhanced or extended government pricing and contracting strategies
• May present pricing certification decks to senior executives
• Leads development, education, communication, implementation and ongoing maintenance of Government Calculations SOPs, systems, data, reporting templates, and the like. Accountable for development and maintenance of effective GP systems and data
• Plays leadership role in development of performance metrics for monitoring, evaluation and reporting of government payer contracts and programs
• Collaborates with Government Analytics & Compliance to create GP-wide training
• Manages development and implementation of Government Calculations-specific training and ensures team members are provided such training in a timely and thorough manner
•  Leads GP project initiatives specific to GP operations
•  Leads department and team to ensure the highest levels of performance for government contracting processes and price calculations, to include maximum efficiencies and compliance:
•  Manages team to ensure accurate and timely completion of pricing calculations  according to the varying legislation, regulations and terms of contracts for government payers and programs
•  Responsible to ensure ongoing and consistent adherence to all applicable laws, regulations, corporate and business unit standards and requirements 
•  Reviews and approves pricing calculations from team members. Ensures pricing calculations are provided to other Government Pricing & Reporting partners to ensure timely and accurate processing
•  Regularly monitors compliance to internal and external policies
•  Manages any issue resolution 
•  Responds to questions from team members and other partners/stakeholders regarding complex issues that may require interpretation
•  Ensures team prepares and delivers routine and ad hoc reporting, as per departmental guidelines, standardized work practices, or otherwise as needed
• Self and team participate in internal and external auditing; including...

The DMPK group is dedicated to enabling the discovery,development and commercialization of safe and effective medicines by elucidatingthe absorption, distribution, metabolism, excretion and pharmacokineticproperties of small molecule drug candidates. We accomplish this through theapplication of state of the art technologies and sciences of bioanalysis, drugmetabolism, drug transport and pharmacokinetics. The DMPK group works in closepartnership with disciplines such as medicinal chemistry, pharmacology,toxicology, pharmaceutical sciences, clinical pharmacology and regulatory tooptimize leads, select clinical candidates, conduct preclinical developmentstudies, support clinical evaluation and contribute to IND and NDA filings.

• Partner with Device Team Leader to define and execute Device strategy in alignment with Technical Development (TDT) & Lifecycle Team (LCT)  strategies.  Develop realistic project plan/schedule and track Team’s progress in meeting milestones and deliverables.  Facilitate Device team meetings in partnership with Device Team Leader to drive sharing of information, decision-making, issues resolution , risk mitigation and team member engagement
• Ensure Device Team plan is integrated with Technical Development Team plan and aligns with overall LCT strategy
• Define and oversee the Device Team project milestones and key deliverables:
• Analyze & understand the critical path activities ensuring Team members are aware of interdependencies
• Drive flow of information across Team members and relevant key stakeholders to facilitate awareness of Team’s efforts and efficient decision-making
• Escalate unexpected events impacting project schedule, budget & resources to management
• Provide regular project updates to management on project status including risk mitigation plan.
• Monitor resource and project variable costs needed to execute Device Plan and work closely with TDT PM to ensure budget is integrated with TDT plan in PlanSource
• Support relevant design control activities outlined in standard and assist with drafting, compilation and tracking of Design Control Documentation as required.
• Support efforts business process improvement efforts including but not limited to updating business process content, implementing tools & best practices and driving awareness across Teams. 
• Maintain knowledge of system performance at sites and business units, through familiarity with local SOPs, frequent interactions with local system owners, and established performance metrics.
• Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies.

• Develop medical strategies based on strong scientific rationale for pre-launch and marketed products in Endocrinology, with a focus on growth disorders

• Establish standards for all Medical Affairs activities, including Sponsored Trials, Supported Trials, Registries and Exploratory Data Analysis of internal and external data bases, publications, medical education, medical communication, Advisory Boards and promotional review.  

• Participate on Franchise Leadership Teams contributing the medical perspective to franchise business strategies and evaluation of new product/development ideas. 

• Work in a cross-functional/matrixed environment, interfacing with Development and Global Medical Affairs personnel to provide the US Medical input into Development programs and Global Medical Affairs strategies

• Responsibility for the medical affairs budgets for the Growth Disorders Franchise to ensure adequate resources and their effective allocation. 

• Interact and manage relations on behalf of Genentech with Key National and Regional Thought Leaders in Endocrinology. 

• M.D. with board certification/eligibility in Endocrinology

Technical/Functional Competencies 

• Relevant therapeutic area experience in Endocrinology (5 or more years, inclusive of academic experience)

• Relevant biotech/pharmaceutical industry experience (2 or more years) strongly preferred

• Considerable experience in the principles and techniques of data analysis, interpretation, and clinical relevance

• Comprehensive understanding of product and safety profiles

Core Competencies / Other Key Behaviors

• Participate on cross-functional teams for evaluation of new products/ development ideas and implementation of franchise business strategies.

• Scientific leadership 

• Leading Teams

• Collaboration and Teamwork 

• Excellent Judgment and Analytic skills 

• Drive for Results

• Effective Communication 

• Integrity

• People Development 

The Jr. Programmer Analyst position will be responsible for providing production support for one or more Managed Care and Customer Operations (MCCO) business application solutions (such as the Contract Administration & Reporting System, Government Price Reporting, Validata, eWorkflow, and Channel & Inventory Management systems).

Duties:

• Provides operational support for Managed Care and Customer Operations business applications, including ticket monitoring, troubleshooting, and deployments
• Diagnoses and resolves user-reported issues within established Service Level Agreement timeframes
• Assists other Programmer Analysts with projects and maintenance & enhancement (M&E) releases as needed
• Consults business users to identify current operating procedures and deliver against business and system objectives
• Monitors and troubleshoot application performance issues
• Maintains system support documentation 
• Drives to complete assigned tasks and demonstrates accountability by contributing to the completion of milestones associated with specific projects.
• Acts as an effective team participant and collaborates on team direction and decisions
• Performs other duties as assigned

Responsibilities:

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

Job Purpose:  

The Head, Safety Sciences, leads and directs one of the therapeutic areas of safety science aligned with the Oncology disease to provide strategic direction and standardization of performance across the Safety Science groups.  

The Head, Safety Sciences directs Product Development Safety's (PDS) disease area specific scientific analysis including medical evaluation, risk assessment and management, signal prediction/detection, Comparative Benefit Risk, using epidemiology and other input as appropriate.  

The Head, Safety Sciences will ensure the incorporation of Comparative Benefit-Risk concepts in the disease area strategy and product plans and their use throughout the development and commercial lifecycle of products assigned to the cluster to ensure their longevity. In general, he/she is a member of a Development Review Committee (DRC).

Primary Responsibilities:

• Ensure proactive surveillance and monitoring activities across theirsafety science cluster to ensure that Roche is aware of potential emergingsafety issues and has developed strategies & action plans to prevent &mitigate risks.

• Direct and manage the SSLs andtheir teams within the safety science therapeutic area and provide guidance tothe relevant development and safety committees as appropriate.

• Maintain managerial oversight ofissues and outputs from the therapeutic area Safety Teams address or elevateissues to the PDS Global Head, Drug Safety Committee, Lifecycle Teams, Research and Early Development teams, and various committees.

• Ensure the incorporation of ComparativeBenefit-Risk concepts & qualitative/quantitative methods in the DiseaseArea (in collaboration with Clinical, Regulatory & Medical Affairs) andtheir use throughout the development and commercial lifecycle to ensure thesafety and longevity of all products in their therapeutic area.

• Leadcontinuous improvement efforts in Safety Science capability and performancetogether with the other Heads of Safety Science areas. Provide leadership and linemanagement to their reports and other members of the Safety Sciences departmentacross multiple locations. 

• Build andleverage Roche and PDS’ influence with internal and external entities to createvalue for Roche.

• Ensure Collaborative and constructive business relationships with majorpartners where applicable (with particular interest in Chugai).  Ensure particular emphasis is placed oncommunication flow and inter company.

• Contributes as part of the Global Leadership Team to the overallmanagement of the Safety Risk Management Department.

• Partners with Clinical Development organization to facilitate and collaborate towards the development of new oncology products proactively. Build strategic relationships with Clinical Development Oncology to drive innovative trial designs and influence decision-making.

Senior Finance Manager 

JOB DESCRIPTION:

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

MAJOR RESPONSIBLITIES

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

Financial Management & Controls

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

Planning and Analysis

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

Reporting

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

MAJOR SKILLS TRAITS:

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

• Lead and/or participate in tech transfers of purification processes across Roche/Genentech’s drug substance manufacturing facilities and to external contract manufacturing facilities.  Requires close collaboration with cross-functional team to implement, validate, and license Drug Substance processes at receiving sites.
• Responsible for providing on-going technical support for Drug Substance production at contract and partner sites. Includes monitoring process performance, resolving manufacturing deviations, participating in quality investigations, and providing technical approval of document and automation recipe changes to support continuous process improvement.
• Lead and/or participate in global initiatives and cross-functional teams in the areas of downstream processing.
• Work collaboratively with site Manufacturing Science and Technology (MSAT) groups to develop and communicate best practices for process design and operations to ensure consistency and compliance across the biologics manufacturing network.
• Represent MSAT Network on corporate initiatives led by partner groups such as Quality, Regulatory, Manufacturing Operations, Pharma Technical Development, etc.
• Provide technical leadership for topics including support for proposed manufacturing process changes, process validation, discrepancy and investigation evaluations, change control, and regulatory submissions. Some lab work may be required in order to resolve investigations and/or demonstrate proof-of-concept for proposed process changes.
• Responsible for authoring and reviewing technical reports, manufacturing instructions, process validation documents, and portions of regulatory submissions to support licensing processes at new manufacturing sites.
• Travel within the Roche network and to contract manufacturing sites will be required.