Job Summary:

Working in early clinical development at Genentech /Roche Inc gives the opportunity to provide translational safety contribution to projects combining good understanding and knowledge of toxicology and expertise in clinical safety and early clinical development, a very innovative approach where Genentech/Roche is a pioneer. 

Job Purpose: The Safety Science Leader (SSL) is accountable for all aspects of safety related to products in early development phase including single case assessment, aggregate reporting, integrated signal prediction/detection (ISP/ISD), integrated risk management process (ISMP) & comparative benefit/risk (in collaboration with Clinical and Regulatory) throughout the life cycle. The Safety Science Leader leads product specific safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate to ensure that adequate safety measures are implemented based on data. ¿The Safety Science Leader maintains an Integrated Safety Management Plan (ISMP) throughout the life cycle of the product or medicine and is accountable for safety components of various documents including study protocol, study reports, development study reports. The Safety Science Leader represents Safety Science in Research and Early Development teams (RED teams) . She/ He supports and facilitates transition of projects from early to confirmatory development for all aspects pertinent to safety. 

Primary Responsibilities and Accountabilities:

·      Contributes to scientific publications (abstracts, posters, papers) for scientific meetings/journals and approves submissions from a safety perspective. 

·      Reviews all communications to the public from a safety point of view. 

·      Keeps the EU QPPV fully informed of any changes to the benefit-risk relationship and, where appropriate, performs tasks as delegated by the EU QPPV. 

·      With the CSL and the DST, plans and performs, on an ongoing basis, an evaluation of the safety data to detect safety signals. On an ongoing basis with the team, evaluates the Benefit/risk relationship of the program and determines how to manage patients within and across trials.

·      Is accountable for safety components of all NDA documents. 

·      Is responsible for the writing and maintenance of RMP/REMS NDA documents. 

·      Represents Roche in interactions with Health Authorities and Independent Data Safety Monitoring Boards (ie Pre-BLA/NDA meetings, advisory committees) for safety related topics.  

·      Contributes to and where specifically delegated may be responsible for the proper execution of the post-approval RMP/REMS 

·      Ensures that all safety processes are properly supported and compliance is documented for all studies conducted by PD or PB or affiliates.

 People Leadership: 

·      Provides provide leadership and line management to the Safety Sciences department across multiple locations, aligning with other parts of the organization, where necessary. 

·      Ensures that the performance of direct reports is proactively managed and that they are coached, trained and developed to maximize their contributions.  

·      Allocates resources and is accountable for the assignment of his/her collaborators / reports according to their individual capabilities and in line with projects priorities.

·      Ensures that staff communication and employee relations are managed proactively to maximize the well being of employees. 

·      Actively installs the Roche values in the Safety Team and their activities.

We are seeking a candidate for a postdoctoral position in the Department of Molecular Biology, to investigate vascular processes.  Research topics include Notch, BMP, Tie2 and EphB4 signaling pathways, and roles of microRNAs in vascular biology.

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.

Job Description

The Senior Business Systems Analyst position will work in Medical Communications and is primarily responsible for but not limited to the following;

• Analyzes business scenarios and identifies opportunities for improvement through automation and/or business process change
• Provides analytical expertise in identifying, evaluating, designing and developing systems and procedures that are cost effective and meet user requirements
• Provides consultation to users in the area of business systems and processes
• Applies advanced technical principles, theories, and concepts related to requirements, data, usability and process analysis
• Facilitate strategic initiatives in Medical Communications/US Medical Affairs, as well as business partners across Roche/Genentech
• Conduct ongoing feasibility studies and gap-analysis for improvements through automation and/or business process changes
• Assist business function areas in understanding strategic problems, opportunities, and the big picture for the functions to make informed decisions to support the business long-term
• Propose strategic recommendations for process improvements and streamlining across the organization
• Articulate and communicate project portfolios alignment with overall business strategies to management and key stakeholders
• Assist management to report business health (success/achievements or areas requiring focus) 
• Liaise with IT to ensure accuracy and completeness in user requirements, functional requirements, technical specifications, process flow diagrams; may configure some system settings and/or options; also, partner with IT to drive implementation of technical solutions.
• Leads cross-functional analytical teams in the resolution of business or systems issues.
• Leads successful completion of major projects/programs across portfolios. Champions accountability by example

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

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

Job Responsibilities:

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

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

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

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

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

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

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

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

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

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

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

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

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

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

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

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

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

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

1.1. Business

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

* Lead project team meetings and technical operations meetings.

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

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

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

1.2. Operations

* Serve as site Technical Lead, ...

This position involves global medicine development activities of a novel biologic agent targeting indications in the field of respiratory diseases.

This job creates a unique opportunity to join a global team that is currently defining its structure and both short-term and the long-term deliverables, and to grow with the team and the franchise.

 As the Medical Director you will be responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within one or more programs. You will also participate in developing the long-range strategic plans for the molecule or molecules within the area of inflammatory diseases.

Key Accountabilities will be:

Assisting in the overall management, planning, evaluation and documentation of projects and studies

Participation in on-going medicine development activities including:

• Preparation of regulatory documents and interaction with global regulatory authorities
• Monitoring and reviewing incoming data
• Analysis, presentation and interpenetration of on-going studies and published data
• Interactions with health authorities and expert bodies
• Close collaboration with drug safety, regulatory affairs, medical affairs and clinical trial operations
• Participation in the preparation of abstracts, posters and presentations for scientific meetings and congresses
• Developing and writing clinical plans and protocols ensuring that they are scientifically sound

To be successful in this role, you will have the following skills and experience:

• Solid experience in medical research including writing clinical study reports and interpreting clinical data
• Good communication and collaborative skills with experience at working with cross functional and external groups, including researchers, clinicians and other stakeholders.
• Proven track record of delivery of experimental or novel studies
• Confidence at presenting at internal and external strategy meetings

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...

• Acts as lead contact for patient insights projects and ongoing consulting regarding the assigned franchises and brands
• Provides an objective commercial viewpoint, based on an in-depth understanding and analysis of patient dynamics and trends as these relate to the assigned franchises and brands: 

• Proactively and continuously monitors the external landscape, as it relates to assigned franchises/brands and existing or potential patient populations. Identifies, assesses and communicates patient trends (e.g., access, reimbursement, personalized healthcare needs, etc.)
• Acts as a thought partner and consultant to all relevant teams, functions and stakeholders
• Works closely with team members in Market Planning, other groups in Market Analysis & Strategy, Franchise Marketing, Patient Marketing, eMarketing and others to identify and plan for patient and related research programs and studies. Identifies, and/or participates in the identification of, critical opportunities for growth, and helps to ensure key patient insights are embedded in the strategic direction of Genentech's current and future businesses
• Participates in the identification of strategic issues or questions to be answered by research projects and/or through leverage of existing analyses and information.  Helps shape and structure patient and related market research programs and studies.  Participates in the definition of questions and required data. Works with his/her manager to identify themes across projects and information sources
• Performs regular and ad hoc patient and related market research, analysis and scenario modeling using primary research from commissioned studies and/or secondary research and analytics. Regular analysis may include patient segmentation, market share analysis and assessment, etc. Employs various analytical methodologies and techniques; and demonstrates understanding of potential and/or limitations of data sources and analytical methodologies. Develops a "command" of data and information sources and a sensitivity to biases.  Performs accurate analyses and thinks creatively about different ways to analyze data and information
• Synthesizes data and identifies implications of patient and related influences relevant to Genentech's current and future business. (Where applicable, performs "meta-analyses" across projects and information sources where similar themes or opportunities may exist.) Draws substantive conclusions from results; identifying implications, challenges or other opportunities, and delineating clear next steps
• Provides internal business partners and stakeholders with a cumulative set of recommendations on patient strategies, plans and tactics (includes risk assessment and mitigation, new business opportunities, line extensions and the like)

• Provides strategic and operational patient insights and recommendations to support various Genentech business planning processes, e.g. long-range Business Plans, 3-year brand and 1-year tactical plans
• Acts as an industry expert on patient research and the general patient landscape, providing ongoing in-depth information and insights to internal partners and stakeholders
• Regularly communicates key patient and related market information to various teams and individuals throughout Genentech
• Complies with all laws, regulation...

System Specialist, gRED Desk-side Support

• The gRED Desk-Side Support Specialist supports multiple computing platforms such as Mac, Windows, Linux, and iOS in laboratory and desktop computing environments. 

• The successful candidate will also apply networking concepts, printer troubleshooting, hardware and software troubleshooting knowledge and data backup technology in day-to-day operations. 

• While working in a highly team-oriented environment, the gRED DSS Specialist will work to achieve defined metrics within the incident management and request fulfillment processes and also be a technical resource to junior team members. 

• The successful candidate would also have the potential to lead team efforts. 

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

The TrackWise Center of Excellence is looking for a highly skilled Computer Systems Validation (CSV) and Software Quality Assurance (SQA) analyst able to perform within the multicultural team supporting numerous GxP TrackWise processes.  We are seeking an expert in GxP computer validation, 21 CFR Part 11 and Annex 11 requirements, and possessing excellent interpersonal, communication and critical thinking skills.

Job Responsibilities:

• Provide estimates and forecasting for CSV and SQA project resource needs
• Assist in developing and approving computerized systems requirements and functional specifications
• Create GxP deliverables such as validation master plans, test plans, installation, operation and performance qualifications (IQ\OQ\PQ), test scripts, validation summary reports, risk control strategies and risk assessments for changes to validated systems
• Conduct system testing for emergency, and maintenance and enhancement releases
• Document and provide feedback to development teams on issues and bugs identified during testing
• Maintain accurate bug tracking and issues resolution logs
• Develop and execute manual and/or automated test documentation in accordance with approved processes and established standards, and in compliance with applicable regulatory expectations 
• Document test results and work with development teams to resolve test deviations; perform root cause analyses
• Develop new processes and process improvements
• Coordinate with cross-functional teams including Quality to ensure accuracy of all testing documentation
• Partner with development teams to support installation activities and configuration management
• Escalate issues and deviations as needed to management
• Provide subject-matter expertise on software quality assurance best practices, regulatory expectations and 21 CFR Part 11 and Annex 11 requirements
• Liaison with Quality to ensure compliance with corporate policies and procedures (SOPs)
• Oversee contract validation personnel
  
  

There is an opportunity in the Technical Regulatory organization at Genentech at the Product Manager level.  This position requires use of regulatory and technical knowledge to develop, execute and oversee regulatory initiatives and strategies.  This individual will work with cross-functional project teams to develop regulatory strategy and ensure the success of regulatory filings through submission of high quality documents supporting the company’s development product portfolio.  Responsibilities will include accountability for IND, IMPD, and BLA/NDA/MAA applications as well as informational and pre-submission meetings with global health authorities, partners, and industry experts.  Additional responsibilities include leading departmental business process initiatives, and proactive communication with Regulatory and cross-function personnel and partners.  Candidates with a combination of broad technical, process and product development, and CMC regulatory experience are desired.

Solution Architect – Regulatory

The Regulatory team is looking for a highly skilled Solution Architect, able to deal with the multicultural team. We are looking for an outgoing and open minded individual with high communication and presentation skills.

The Position

The Regulatory Information Management (RIM) Solution Architect is responsible for the architecture of our RIM systems including Global Product Registration System (GPRS), Product Information Dissemination (PID), Q&A, XEVMPD, Protocol Reporting System (PRS) and RADAR, as well as a key contributor to develop these systems to a state where they fulfill the current business needs and are well prepared to meet future demands. 

The main responsibilities are:

• Working in a multinational team of employees
• Oversee the technical solutions
• Document the as-is architecture
• Develop the future-state architecture
• Develop a roadmap for the systems
• Support the ongoing projects and design solutions on the existing platform
• Providing guidance in area of expertise to Project Managers and Technical Leads

We seek a highly motivated Scientist / Sr. Scientist to lead biomarker development efforts in support of Genentech's Oncology pipeline. The incumbent will lead a small laboratory group focusing on predictive and/or pharmacodynamic biomarker development efforts, as well as lead and support biomarker subteams for programs in clinical development.

All of the Scientists in OBD are encouraged to develop a focus in one of several areas that advance our understanding of specific diseases or enable advanced biomarker assessments through exploration of innovative, cutting-edge technologies.

For this particular position, a strong background in cancer immunotherapy or the biology of the tumor microenvironment, evidenced by peer reviewed publications in top tier journals, would be an important asset. The successful candidate is expected to effectively lead cross functional teams, to publish innovative biomarker or disease focused research in high quality scientific, technical or medical journals, present to our key investigators and at meetings and promote collaborative efforts to push biomarker sciences forward. Scientists / Sr. Scientists in OBD are expected to be, or develop into, externally recognized leaders in clinical translational sciences.

As a Scientist / Sr. Scientist, you are expected to:

• Provide exceptional scientific leadership within OBD, as well as to other functions, subteams / teams at Genentech / Roche Develop and effectively manage a small laboratory group, predominantly focused on scientific support for molecule programs
• Drive scientific and technical innovation collaboratively with other members of the Department Lead one or more biomarker subteams
• Develop and execute on lead and exploratory biomarker strategies for one or more projects
• Participate in, or lead, disease focused translational biomarker programs, or develop a key focus on novel technologies that advance clinical biomarker assessment
• Publish in high quality scientific, technical or medical journals
• Represent OBD externally through presentations at key National / International meetings, interactions with our key investigators
• Participate and thrive in an interactive, team oriented culture

Sr. Product Manager

 Senior Product 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

• 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; using to determine and recommend managed care marketing strategies, plans and activities that support optimal formulary  positioning, reimbursement, access and overall market share

• Contributes new creative, innovative opportunities; increasing adoption, pull-through and overall financial results

• Develops the Value-based Healthcare (VBH) strategy and tactics; including driving and shaping key customer partner initiatives in oncology

• 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

• Conducts field visits with key customers to review Genentech’s breadth of offerings

• Develops key VBH resources for MCCO (Managed Care & Customer Operations) field, collecting customer insights, creating tactics for case managers and training MCCO on resources

• Where applicable, supports product launches. May participate in the development and implementation of managed care marketing launch plans. Includes contributing managed care marketing expertise to other aspects of the overall launch plan and helping ensure launch plan excellence

• 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.

• Provides strategic consultation to brands and MCCO groups regarding key brand market events

• 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
  Complies with all laws, regulations and policies that govern the conduct of GNE activities
  

Summary

Responsible for producing innovative Biotherapeutic medicine by interfacing with production systems and controls in a cGMP manufacturing environment, maintaining areas of responsibility in a high state of inspection preparedness, managing the performance of both manual and semi - automated warehouse processes to support manufacturing unit operations, collaborating with the network to implement multi-site process improvement initiatives/CAPAs and executing department objectives to support strategic goals.  Partners with the business to deliver business results focused on establishing and improving business processes to improve reliability, increase simplicity, and enable growth, while utilizing a DMAIC data-driven, problem solving methodology to deliver tangible business results.  Responsible for business process analysis, design and optimization to enable the routine delivery of exceptional performance. 
 

Job Responsibilities

Applies a complete understanding of theories and concepts from one's technical/professional discipline to independently address a broad range of difficult problems.May determine methods and procedures on new assignments.

Essential
¿ Manage and resolve technical and compliance issues with Quality, Maintenance, Calibration & EH&S.
¿ Lead teams to execute internal/cross functional and network related projects that may include investigating, analyzing, formulating solutions, identifying improvement opportunities, documenting processes, training, process/system performance improvement and cascading results to management.
¿ Partnering with the customers, communicating/coordinating/bringing together key stakeholders, and delivering real value-add sustainable solutions.
¿ Act as SPOC for compliance or regulatory agency issues within the department
¿ Identify the technical, procedural and equipment issues that may compromise production and compliance, working closely with cross functional / network groups to identify and implement solutions.
¿ Implement and follow through on corrective and preventative actions for variances or regulatory observations.
¿ Represent the department in reviewing and approving all production related documentation requiring approval such as process validation protocols and final reports, planned and unplanned variance reports, documentation change requests, engineering and facility change requests, and validation protocols.
¿ Supports department to meet corporate goals and department objectives.
¿ Representing the department as the change agent.
¿ Deliver project goals on budget and on schedule.
¿ Make recommendations to Management based on business case and analyses.
¿ Lead decision making support and make recommendations regarding best options.
¿ Communicate proactively with stakeholders regarding progress, issues and plans for resolution.
¿ Develop and use project plans to coordinate participants and track and report progress.
¿ Ensure improvement methodology and tools are utilized effectively to maximize benefits.
¿ Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals.
¿ Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes.
¿ Innovative and effective in solution development, risk mitigation, and execution.
¿ Work collaboratively with network to implement multi-site process improvement/CAPAs to mitigate compliance related risks.
¿ Ensure that all operations are performed with 100% compliance to documentation cGMP standards.
¿ Ensure maintenance of a safe warehousing work environment that complies with company and state regulations.
¿ Submit reports and compile data for trending and identifying problem areas.
¿ Collaborate with other departments to address issues and meet deadlines.
¿ All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
¿ Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.  Fosters a positive safety culture in which no one gets hurt.