A position is available in the Protein Analytical Chemistry department for a Scientist with relevant analytical skills related to the biopharmaceutical industry. The candidate must have strong knowledge and hands-on experience in analytical characterization of recombinant therapeutic proteins, development and validation of quality control methods, and application of emerging analytical technologies. The candidate should have experience in or be highly familiar with the development of analytical methods covering a wide array of techniques such as HPLC, capillary electrophoresis (CE) and mass spectrometry. The Scientist will design and execute analytical characterization studies to identify critical quality attributes and enable a commercial control system for a late stage product. A strong understanding and knowledge in analytical control strategy development and cGMP is highly desirable.

The Protein Analytical Chemistry department is part of Genentech's Pharma Technical Development Biologics organization and is responsible for method development and detailed structural characterization of recombinant proteins to support the clinical and commercial biotechnology product portfolio.

• Provide support for specific projects in the neuroscience and immunology indications using in vitro electrophysiological techniques as well as standard medium and high-throughput biochemical and cell-based assay technologies.
• Develop, optimize and validate protocols for ligand and voltage-gated ion channel targets to execute ultra-high throughput screening campaigns and evaluate the structure-activity relationships (SAR) and mechanism-of-action of small molecules in the context of multi-disciplinary project teams.
• Provide scientific guidance to the prosecution of ion channel small molecule targets, including assay development, assay cascades, and counterscreening strategies.
• Leadership in employment or development of new technologies, including medium throughput electrophysiology equipment
• Collaborate closely with our medicinal chemists, in vivo pharmacologists, and therapeutic area biology experts.
• Provide leadership and guidance to a focused team of direct reports, including junior PhD level scientist(s) as well as highly experienced Senior Research Associates.

Summary of Position:

The Clinical Safety Associate I (CSA I) assists in the clinical processing of adverse event (AE) information received by US Pharmacovigilance (USPV).  Responsibilities are performed under the direction of the USPV Manager. 

Job Duties/Responsibilities:

• Demonstrated knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements.
• Performs a review of ancillary documentation accompanying ICSR reports and identifies pertinent clinical information for incorporation into the case narrative.
• Performs Data Capture and Quality Review for all molecules and serves as a back up for additional projects.
• Identifies and initiates requests for case follow up for clinical trials and post marketing adverse events.
• Works with Submissions Team Responsible to properly identify US regulatory reporting requirements.
• Demonstrates a general understanding of appropriate labeling documents for assigned project(s).
• Demonstrates knowledge and understanding of safety exchange agreements (if applicable).
• Participates on Study Management Teams (as applicable)
• Assists in the development of drug safety presentation for investigator meeting presentations.
• Assists in clinical trial reconciliation process (as applicable).
• Organizes work load to ensure compliance with regulatory timelines for ICSR reporting.
• Ensures departmental workflow processes and timelines are followed. 

Competencies Identified for Success:

• Works effectively as a team member and promotes collaboration
• Demonstrates initiative and accountability
• Strong organizational skills, detail oriented, ability to adapt to change
• Confident decision maker

The job responsibility within the ADQC--Biological Technologies Testing Group is to perform cell-based and immunochemical/biological assays in support of process development, stability, and lot release testing with established procedures in a GMP environment.  Role includes reviewing assay packets and releasing assay data as well as prepare assay reagents, generate computer results, monitor assay quality, use of LIMS, maintain the lab via Lean tools such as 5S and EHS safety practices.  Expectations include lab maintenance and project support/equipment qualification/computer systems/document management as needed.

Reportingto the Vice President – SSF  Production, the Director of Technology willbe responsible for manufacturing science, validation, automation, recipe anddocument development and engineering functions in direct support of production.

*Provide support to operations departments in make, assess, release activities;plan and execute process related capital projects within the plant incollaboration with Corporate Engineering; work closely with GlobalManufacturing Sciences and Technology (MSAT), Process R&D, RegulatoryAffairs and Quality, representing the plant on technology transfers, regulatoryagency inspections and other issues and projects; foster innovation intechnologies, processes and systems as part of continuous improvement and cGMPefforts.
* Ensure goals, priorities, budgets and strategic plan are appropriatelyestablished and aligned.
* Ensure proper resources are available (people, materials, equipment,facilities, processes) to meet current and future goals.
* Ensure an uninterrupted supply of product in the near- and long-term.
* Ensure systems are in place to successfully complete regulatory inspections.
* Plan & manage to continuously improve safety, quality, reliability andefficiency.
* Actively promote and lead Continuous Process Improvement (CPI), Root CauseAnalysis (RCA), and risk assessment tools such as FMEA.
* Ensure qualified staff are hired, trained, developed, and recognized.
* Develop, review and approve GMP documentation and regulatory submissions.
* Work in partnership with other Genentech staff to develop and championpolicies, best practices, decisions and strategic plans.
* The incumbent will be responsible for directing, managing, and orchestratingTechnology functions within the South San Francisco Drug Substance and DrugProduct manufacturing facilities utilizing CHO and Bacterial production systems,and liquid and lyo fill lines to make commercial and clinical product.  

• Development of new in vivo models of autoimmune, inflammatory, and infectious diseases that reproduce significant aspects of human pathophysiology, as reflected, in part, by response to human standard of care therapeutics or their surrogates.
• Generation of new assays in preclinical species to ascertain and understand PKPD relationships of specific new molecular entities (NME), as well for the performance of efficacy experiments with NMEs in appropriate models.
• Interaction with discovery laboratories in which the NMEs are generated in order to design and execute appropriate experiments to characterize the NMEs and their effects, as well as to develop technologies required for the pursuit of the scientific objectives of the discovery laboratories and of Translational Immunology.
• Translational Immunology representation on NME teams. These roles will be performed both in his/her own laboratory and by oversight of three additional laboratories.

(External Quality, Commercial Drug Substance)

Sr. Technical Manager, Tech Transfer – Biologic Drug Substances (SSF)

Main Purpose of the Position: 

* Provide Quality oversight for Roche and Genentech products manufactured at Contract Manufacturing Organizations (CMOs) to ensure compliance with cGMP regulations and Roche/Genentech standards. 

* Serve as the Quality single point of contact for designated CMO(s) and participate as a key member of Drug Substance (DS) CMO governance teams to support site selection, product technical transfers and on-going external commercial site management.

Responsibilities:

* Participate in site selection and product technical transfer activities at CMOs, such as due diligence audits and GMP readiness activities.

* Manage all required activities to support release of commercial product including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls. 

* Develop, negotiate and maintain CMO cGMP quality agreements and ensure compliance with agreements.

* Develop/maintain quality risk management plans; utilize risk management tools to identify and mitigate CMO quality and compliance risks, ensuring CMO sites are in a state of continuous inspection readiness.

* Participate in regulatory inspections and cGMP compliance audits, collaborating with CMOs to ensure on time closure of associated CAPAs.  Support regulatory filings for products manufactured at CMOs.

* Support creation of Annual Product Reviews, product complaint investigations, and other quality functions as required.

* Establish CMO goals/metrics and monitor and report progress. Lead or participate in CMO or cross-functional process & quality improvements projects.

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...

• Manage Quality system for change control and document management functions for GMP changes involving equipment, documents, test methods, processes and specifications for IMP Small Molecule and Biologics operations.
• Manage workflow through Trackwise and EDMS to ensure timely release of systems and documents.
• Proactively identify, prioritize and assess quality systems compliance risks across the IMP network
• Manage Quality System for discrepancy and CAPA management for IMP customers.
• Perform routine Quality trend analysis of IMP discrepancies and audit of incident discrepancies.
• Manage workflow through Trackwise discrepancy and CAPA systems
• Manage and oversee GMP self inspection program for IMP manufacturing and testing areas including:
• Maintain plan and schedule for self inspection audits
• Coordinate self inspection audits with other subject matter experts.
• Issue audit reports and track corrective actions from audits.
• Communicate to PTDQ-U leadership regarding compliance status
• Provide Quality oversight to GMP IMP Contract Laboratories/Organizations.
• Maintain list of approved contract testing laboratories and corresponding Quality Agreements
• Provide support for establishing new Quality Agreements, revising or renewing existing Quality Agreements, and periodic review of Quality Agreements
• Participate in lab audits as needed
• Serve as the QA representative on cross-functional and multi-site teams.
• Facilitate continuous improvement and the sharing of best practices at the various IMP global sites
• Provide guidance to internal and external customers on best practices for various Quality Systems.
• Mentor and supervise (as required) other Quality System staff members on Change Control, Discrepancy, CAPA, Self-Inspection, and Quality Agreements and or related processes and projects.

Summary of Position:

The Compliance & Training associate reports directly to the Manager, Compliance & Training. This individual will work closely with the US Drug Safety staff to support all safety-related activities accountable to US Drug Safety.  In addition, interactions US Medical Affairs Compliance will also occur on an as-needed basis. 

Job Duties/Responsibilities:

• Training of vendors and other 3rd parties to drug safety reporting requirements
• Working with commercial organization to ensure monitoring of Genentech sponsored websites for adverse event reporting
• Oversight of US Drug Safety audit and inspection findings and CAPAs
• Oversight of US Drug Safety local procedures and controlled documents
• Management of US Pharmacovigilance & Safety Data Exchange agreements 
• Management of US Drug Safety global pharmacovigilance commitments
• Monitor IT issues
• Management of special projects
• Track US pharmacovigilance metrics
• Conduct vendor assessments for AE reporting compliance
• Interact, where applicable, with US Medical Affairs Compliance to address safety-related issues or concerns

Provides the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.

Main Responsibilities and Accountabilities:

• Provides direction and leadership to one or more clinical operations teams
• Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
• Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
• Creates team culture and promotes team spirit.
• Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.
• In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members.
• Oversees the development and maintenance of study specific manuals created by the GSA.
• Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
• Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL.
• Develops and manages clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans.  Communicates variances in the budget and action plan for resolution to the GSL.
• Establishes study milestones and ensures accurate tracking and reporting of study metrics. 
• Provides operational input into the development of protocol feasibility questionnaires. 
• Provides clinical operations expertise to ensure operational feasibility and delivery
• Leads the development and finalization of site feasibility questionnaires.
• Leads the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and OPL.
• Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes.
• Analyzes the feasibility data across countries with input from the affiliates and makes recommendations to the GSL for the strategic country and site distribution and patient numbers.
• Oversees forecasting of clinical/non-clinical supplies
• Designs drug assumption and supply chain process in partnership with Pharma Technical Drug Supplies, affiliates and GSL.
• Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study.
• Delivers the operational elements of the study plan
• Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings.
• Ensures that reporting of SUSARs is established and maintained for the duration of the study.
• Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL and implements contingencies in consultation with the GSL.
• Primary contact with affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action.
• Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits.
• Oversees the maintenance of drug supplies and resolution of issues with input from the Pharma Technical Drug Supplies.
• Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs.
• Provides operational input into the development and tracking of SMT goals.
• Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
• Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
• Develops and executes appropriate site and CRO/vendor audit and quality plans.
• Identifies areas of best practice and process improvements
• Participates in Pharma Development Operations initiatives and programs as assigned.
• Maintains oversight and ensures consistency of the operational aspects across studies within a project.
• Ensures study adherence to ICH/GCP and SOPs
  

• Is a standing member of the site and/or regional Regulatory Technology Leadership Team
• May lead the site or regional Regulatory Technology management team. Drives best practices and operational excellence within the department and cross-functionally and ensures timely communication and information dissemination across the department and beyond
• As needed, ensures appropriate appointment of staff members as ad hoc members in Regulatory Affairs Functional Teams (RAFT); driving and ensuring effective and efficient support for cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
• As assigned, self and staff may act as standing or ad hoc members of other teams for special or ongoing initiatives and projects

• Develops and manages annual and/or longer-range departmental budgets and resource plans
• Tracks departmental expense budgets to ensure compliance with agreed parameters
• Where applicable, self and team may participate in the negotiation with and commissioning of external vendor partners to support the work of Regulatory Technology
• Accountable for appropriate resourcing decisions for assigned Regulatory Technology function and staff
• Cascades strategic and other relevant goals and objectives as well as budget and other resources to direct reports
• Leads recruitment, hiring and on-boarding for his/her staff member positions. May include, as needed, short-term contract personnel
• Plays a lead role in creating and maintaining a positive work environment by encouraging mutual respect, innovation and accountability at all levels (global, site, functional, projects/programs)
• Ensures that performance of assigned Regulatory Technology management and staff is proactively managed and that management and staff are appropriately trained, developed and coached to maximize their contribution and ensure compliance with Roche and regulatory guidelines and standards. Accountable to ensure assigned management and staff consistently complete their deliverables and other responsibilities on-time, on-target and within-budget
• Conducts ongoing performance management and completes the required steps of Roche’s performance management process and cycle. Includes individual development plans/career discussions and actively contributing to performance calibration, talent management and succession planning processes
• Actively participates in management and skill development programs for continued professional development
• Leads routine and ad hoc meetings with assigned Regulatory Technology management and staff
• Identifies, recommends, assigns or otherwise undertakes special projects that further the success and effectiveness of Regulatory Technology and/or PDR overall
• As needed or otherwise appropriate, acts as a substitute for his/her manager in various meetings, communications or other forums
• Consistently complies...

The Senior Corporate or Corporate Counsel will work as part of the Healthcare Law Group within Genentech's Legal department. 

The position will initially focus on counseling Genentech’s commercial sales and marketing clients, with opportunities to advise medical affairs and development across the lifecycle of products. The position may require counseling medical affairs and development teams with human medicines and companion diagnostics in all phases of development.  

 JOB/POSITION SCOPE:  

•  Manage outside counsel on complex or more advanced matters or projects 
•   Responsible for one or more key client relationships typically at Director level or   higher 
•  May be single point of contact or represent practice group or functional area on significant projects or committees 
• Provide advice, education, training and legal direction on FDA labeling and promotional matters, healthcare fraud and abuse laws, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products;
•  Assist in structuring tactics and related contracts in compliance with applicable law;   
•  Serve as lead legal counsel for global development programs and medical affairs initiatives
• Negotiate agreements with cooperative groups, government entities, study sites, and other parties involved in global studies; and
• Draft and interpret  company policies, and educating clients and colleagues about enforcement trends and discrete legal issues.   
• Act as a subject matter expert on all matters relating to healthcare law and related business operations 
•  Act as a standing or ad hoc member of business or leadership teams and provides legal counsel and expertise into business decisions 
•  Develop an in-depth understanding of assigned departments and functions in terms of their, organizational structure, processes, business goals, strategies and challenges, etc. 
•  Provide  legal advice in matters relating to healthcare law, including healthcare fraud and abuse, FDA regulations on clinical trial conduct, labeling, advertising and pharmacovigilance, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to the development, manufacture and commercialization of products 
• Provide  input and legal advice on business strategy, tactical plan development and implementation, and other business issues; including legal assessments, solutions-oriented risk mitigation strategies, messaging, and interactions with healthcare professionals, patients and other external parties 
•  Participate  in, lead  and/or present  to various Company committees or other advisory, project or work teams and provides healthcare and business law expertise and guidance 
•  Review  business materials (clinical trials, brand plans, promotions, medical plans, publications, training documents, etc.) requiring legal input and advises internal clients, partners and stakeholders on compliant strategies, plans and tactics 
•  Provide  transactional support to assigned internal clients. May include drafting, negotiating, and/or reviewing contracts, creating, updating and training on contract templates, negotiating language, developing associated legal/contractual documentation and/or policies & procedures, and counseling on contract disputes   
•  Interact and communicate with Roche affiliates and global partners, as appropriate, to apprise them of relevant Company policies, procedures, practices, important business issues, etc. and share best practices or coordinate legal support 

 PEOPLE MANAGEMENT: 

• May manage administrative personnel 
• Where applicable, lead recruitment, hiring and on-boarding for direct report positions 
• Accountable for direct reports' work to ensure on-time, on-target and within-budget results 
• Ensure direct report(s) are appropriately trained, developed and coached 
• Responsible for performance management of direct report(s)

DEVELOP & MAINTAIN  KNOWLEDGE 

• Stay abreast of evolving healthcare and related legislation and regulations and the enforcement landscape. Advises the Company and colleagues of potential implications to current or future strategies and operations and assures ongoing compliance 
• Develop and implements training to educate internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal c...

The Clinical Pharmacology Department at Genentech, Inc. isseeking a Ph.D. level Senior Scientist who is driven to understand the clinicalpharmacokinetics and pharmacodynamics of novel drug candidates in the area ofOncology.  This individual will beresponsible for the clinical PKPD activities of Biologics, Antibody DrugConjugates and/or Small Molecules in clinical development. This person willhave responsibility for the Clinical Pharmacology strategy in order to ensurethat appropriate dose/route/schedule decisions are made using the state of theart modeling and simulation strategies that are aligned with project needs.This will be accomplished by working in close partnership with Clinicians, Biostatisticians,Clinicians and project teams.  Responsibilitieswill include planning and reviewing study designs, analysis plans, data analysis,interpretation of PK/PD as well as planning, implementation and organization ofregulatory filings (worldwide) and presentation of data at cross-functionalteams, department meetings, conferences and regulatory meetings (worldwide).Additionally this individual will also be directly involved in leading projectsub-teams and representing the function at cross-functional project teams.

This position may be filled at a Manager, Analytics & Compliance - E4 or a Sr. Manager, Analytics & Compliance level - E5
 
Manager, Analytics & Compliance will support Government Pricing & Reporting (GP) teams and collaborate with key business partners, including other Strategic Pricing & Contract Management (SPCM) teams, Distribution Strategy, Government Affairs, Finance, Legal and Brand Marketing to deliver deep insights and actionable strategic and tactical recommendations that enable Genentech to rapidly and appropriately adapt to evolving U.S. government payer practices, policies, relevant legislation, regulations, trends and other dynamics . Frame and structure approach, research, analyze and synthesize information on the changing/evolving external landscape and internal strategic proposals for implications to government calculations, pricing and other related activities. Perform complex, strategic analysis of Medicaid, Medicare and VA/FSS data, including advanced forecasting, predictive analytics and trending, in order to proactively address current and future scenario planning, solve for “what if” type questions from stakeholders, and determine the impact of regulatory and other relevant changes.

Analytics & Compliance Managers play a leadership role representing Government Pricing & Reporting to cross-functional teams.

Analytics & Compliance Managers also play lead roles supporting GP Calculations and Medicaid Claims processes by advising on impacts of regulatory and other relevant changes to government payer claims and rebates and developing GP methodologies.

Acts as a subject matter expert and trainer on government payers and programs, as these relate to government pricing, contracting, administration, reporting and related matters.  Incumbents in the Manager/Senior Manager Analytics & Compliance role, as all other employees, are fully accountably for compliance with all laws, regulations and policies that govern the conduct of GNE activities.

Technical Skills: Actively Provide Strategic Support and Regulatory Impact Analyses to Relevant Business Partners [relevant business partners – see above description]

• Conducting Analyses & Scope and Structure Key Strategic Driver Business Questions. With some support and guidance from manager, assumes full accountability for asking questions of partner experts to seek deeper understanding of real drivers of decision-making and to identify core business questions. Proactively seek out complex information on changes in laws and regulations. With some support from manager, appropriately scope and structure projects, establishing a framework, key deliverables, and milestones in alignment with key stakeholders. Demonstrate ability to break complex problems down into distinct parts, simplify complexity, and manage uncertainty.
• Deriving Insights. With some support and guidance from manager provide strategic insights and recommendations to relevant partners by linking learnings across projects. Assess appropriate use of secondary research and internal data, leveraging internal expertise and resources as appropriate. Develops appropriate responses with supporting analytical justifications, including recommended changes in complex pricing and contracting strategies. Complement quantitative analyses with government payer and program knowledge to provide qualitative recommendations regarding potential implications or other impacts to Genentech’s business.
• Develop and Maintain Analysis Tools. Conducts quantitative analysis of government payer programs’ data to identify and provide data-driven insights and support government reserves forecasting; includes forecasting, trending and data mining. Maintain relevant data and information into respective departmental/company systems and databases to ensure current, accurate and robust analytics and reporting. Participates in the development, education, communication, implementation and ongoing maintenance of GP analytical methodologies and models, data and reporting templates.
• Presenting Results. Presents objective insights from analyses to relevant partners up to and including CLC. Produces and disseminates routine and ad hoc reporting to ensure GP and other cross-functional partners and stakeholders are kept fully abreast of key information relating to assigned government payers and programs. Creates and implements standard and ad hoc reports.
• Level of Expertise. Responsible for updating relevant government program methodologies and keeping these current at all times. Is knowledgeable in a variety of structured problem solving frameworks, market research methodologies, and excel forecasting techniques, and can apply them across business questions. Develops relationships and collaborates with relevant cross-functional partners to deliver respective subject matter expertise (see above j...

The candidate will be working in the design, performance and analysis of virus clearance studies, evaluating virus removal by protein recovery processes. Candidate will execute chromatography and/or filtration processes and perform Q-PCR, or cell-based, assays. Candidate will be responsible for scaled-down chromatography and filtration of the recovery process, as well as virus nucleic acid purification and quantification. Candidate will write GMP protocols, summary reports and execute validation studies. Depending on the business needs, candidate will support the development and implementation of recombinant protein purification process from laboratory to manufacturing scale.  The work may include purification process development, optimization, characterization, and validation. The work includes projects carried out at laboratory, pilot plant, and industrial scale using separation unit operations including column chromatography, filtration, and centrifugation. The successful candidate will also collaborate with many different functional groups and work on the development of state-of-the-art technology on viral clearance or protein purification.

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