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 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
  
  

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

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 Associate Program Directors provide regulatory leadership for one or more regional development projects. Regulatory Program Management Associate Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Regulatory Program Management Associate Program Directors are expected to lead their assigned projects and represent PDR to cross-functional teams and groups with supervision. Regulatory Program Management Associate Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners. Regulatory Program Management Associate 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.

EXAMPLE DUTIES AND 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 and regional 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 projects at any one point in time

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 and/or regional 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 and/or regional 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 ...

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

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.

The aim of this job is to support the global Business Process Owner / Head of CoE for the global Learning Solution to establish and maintain a global Learning Solution across the Roche organization, in particular in your area of responsibility. Located in South San Francisco, you provide consultation to the Business in the assigned regions and functions. You work with the local and functional Business Process Owners to ensure that the global processes and standards are embedded in the respective organizations.  In this position, you support the End-to-End Lead in identifying were process and system improvements are required and scope the   initiatives and projects. You are responsible for the delivery of assigned initiatives for your area and across the Roche world in collaboration with the CHRIS LSO servicing and support organizations.

The main responsibilities are:

• Stakeholder management and consultation to the business in the assigned regions and functions:
• North America  
• Latin America
• Middle America
• NAM and LATAM Commercial Operations
• Pharma Manufacturing (PT)
• Diagnostics Manufacturing
• Act as single point of contact for the business, functional and local BPOs
• Gather needs and areas for continuous improvement based on input from the Business,  and address those to the End-to-End Lead and global Business Process Owner / Head of CoE
• Balance local requirements for the assigned area with those of the global and group functions
• Execute the delivery of assigned initiatives (e.g. E2E) across all regions and functions in close collaboration with the CoE and business counterparts
• Liaise with the CHRIS LSO support and servicing organization on new requirements and on the delivery of initiatives
• Enforce the implementation of end-to-end processes locally and functionally (esp. where no dedicated local BPO exists)
• Provide input to global process documentation
• Support change management

• Focuses on process optimization and continuous improvement of existing Identity & Access Management processes and tools
• Follows established processes and standards in the execution of daily duties and job function

• Develops the Identity and Access Management services
• Promotes the Identity and Access Management services with all customers
• Supports the integration process of new or updated components by following established standards and providing the expected deliverables for handing over the service to operational teams and customers.

• Supports the integration of registration processes within the company’s identity management solution with focus on improving the operational environment, processes and procedures including data migration activities
• Follows appropriate SOPs and instructions required for the integration of registration services

• Manages the configuration and master data by assessing and specifying the possible need of data quality improvements
• Applies change management processes while managing the Identity & Access Management process integration
• Support the integration of business processes and applications by leveraging the Identity and Access Management infrastructure, tools and directories and following project management best practice.

• Manages the analysis, design and handover of access registration processes to the operational teams
• Ensures proper documentation and training material regarding registration processes is in place and kept up-to-date
• Manages the identity and access management processes to meet OLAs/SLAs by adhering to regulatory and qualitative requirements
• Increase process efficiency and cost effectiveness while providing identity and access management services
• Manage the integration of registration processes with focus on improving the operational environment, processes and procedures
• Manages and maintains the registration process portfolio
• Monitors and verifies the effectiveness of registration processes through established KPI and trend analysis
• Contributes to audit processes
• Based on business needs, identifies and proposes innovative, integrated, economically viable solutions
• Integrate identity and access management processes by meeting SLA requirements
• Supports that all solutions, documentation and procedures are implemented and maintained in a fully qualified and current state as applicable
• Registration processes are clearly communicated and trained
• Continuously strives for increase the skill level and expertise in the corresponding area
• Keeps abreast of business needs by maintaining close relationship to service management and other support services teams.
• Ensures compliance to Roche and Informatics Standards for technology, monitoring and support tools, SOPs and policies
• Ensures that documentation is current and accurate, SOP’s are understood and adhered to and platforms operate in highly secure and qualified environments in compliance with Audit, Regulatory and Validation requirements
• Ensures SLA requirements are understood and the required processes are implemented and managed to support compliance
• Provides shared platform support services as agreed (SLA or other) with the SM functions and other service consumers
• Provides input to support service levels and costs
• Fosters a working environment that encourages team members to fully contribute to achieve Roche’s goals
• Actively provides feedback to customer and team seeking for process improvements and efficiency gains
• manages the different integration projects within the portfolio to integrate new/existing IM applications into the service
• ensure standardization and globalization of application registration services by improving the operational environment, processes and procedures
• interface with the corresponding Engineering team if new features/interfaces are required
• ensure proper testing of application registration integration
• handover of new productive application registration processes to the operational team(s)
• create metrics/key performance indicators and develop/apply ...

This position is for a Principal Engineer/Principal Manufacturing Technical Specialist reporting to the Associate Director of Technology Validation in the South San Francisco Production Technology Department.  The candidate will independently lead highly complex compliance and transformational validation program projects.  The candidate will also be expected to lead site implementation of complex multi-site CAPAs and quality system deployments.  These projects require close collaboration with site Manufacturing, MSAT and Quality and other functions as well as network colleagues and corporate quality functions over the course of multiple years.  This candidate will sit on the Technology Validation Leadership Team and will assist the Associate Director in developing group goals and development plans.  The candidate must provide mentorship and direction to staff on interpretation of the Roche Quality System requirements, execution of the Qualification Lifecycle and Qualification Strategies for highly complex projects.  This candidate will also be responsible for representing Genentech in agency inspections and audits.  They will participate in network teams developing quality system approaches.

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

Further responsibilities are:

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

Dept: Biological Assays, Method Management and Technology, PTQBP

Job Category: Quality
Location: SSF

Department: MMTech (Method Management and Technology)
Description: Senior Scientist Bioassay

Summary

The Biological Assay Function within Genentech’s Global Quality Organization is responsible for life-cycle management and innovation of post-BLA biological potency methods and specifications. We serve as the scientific and technical Center of Excellence for biological assays and analytical ELISAs within Commercial Quality for the Roche/Genentech Global Quality Network. We are looking for an experienced Senior Scientist to take on a leadership role and to play an integral part in the function.

 
Requirements

Candidates must have in-depth experience in the development of cell-based potency assays and immunoassays in an industrial setting. Understanding of mechanism-of-action of antibody-based protein therapeutics is essential. Broad experience with a variety of biological in-vitro systems is required. Familiarity with antibody effector function determination and enzymatic assays would be an asset. Prior experience in assay validation/ qualification and technology transfer are highly desirable, as is GMP experience and a strong sense for compliance. Familiarity with common applications analyzing the dose-response relationship will be very helpful (SoftMaxPro, XLFit, PLA etc). Working knowledge of statistical approaches will be helpful. Must be highly motivated and comfortable working independently in a fast-paced environment. Experience with regulatory submissions (IND/BLA) and Health Authority interactions will be advantageous. Management experience of direct reports is expected.

Join a Biotechnology Leader
For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to develop novel medicines for serious and life-threatening diseases. Today, Genentech is among the world’s leading biotech companies, with multiple therapies on the market for cancer and other serious medical conditions.

Our founders believed that hiring talented, enthusiastic people would make Genentech a success. Today, we still believe our employees are our most important asset. For this reason, we aim to provide employees with a stimulating and collaborative environment where they can make important contributions to medicine and thrive as professionals.

THE POSITION:

The Senior / Market Planning Manager participates actively in Genentech’s commercial planning efforts by providing unbiased, objective, in-depth information on current and future markets, product performance, customers and competitors. He or she has first-line accountability for Market Planning contributions to commercial and cross-functional teams, management of team relationships, and provision of information and recommendations to stakeholders.  Additionally, the Senior / Market Planning Manager identifies critical business issues and opportunities for growth, collaborates with Genentech teams, and works to embed an external market point-of view into the strategic direction of the company. He or she also supports product launch or line extension activities and helps the organization make optimal decisions regarding the lifecycle of the product.

MAJOR RESPONSIBILITIES:

• Evaluate the market landscape, monitor changes and predict trends in market dynamics and competition.
• Provide an objective market viewpoint based on an in-depth understanding and analysis of customer and environmental information. Provide recommendations on marketing strategies and tactic effectiveness.
• Create, validate and refine patient-based, long-range forecasts for product. Communicate revenue information throughout the organization.
• Act as an internal consultant to stakeholders across marketing, sales, managed care marketing, clinical, regulatory, finance, manufacturing, and other functions, to support strategic decision making and help maximize Genentech's commercial success.
• Partner with other brand teams across Market Analysis & Strategy and other Commercial Operations functions to provide a holistic analytical viewpoint to the brand teams.
• Effectively employ primary market research and leverage secondary data to accomplish the above.
• Contribute to the success of the department by leading cross-departmental projects.
• Potentially mange and develop one or more direct reports.

CAPABILITIES:

• Strong command of a variety of analytical and market research techniques, sought out as an analytical expert and, more importantly, as a strategic advisor. Grasps key issues quickly, understands the "big picture" and links market insights to larger issues.
• Uses rigorous logic and methods to solve difficult problems with effective solutions.  Can see hidden problems; looks beyond the obvious and doesn't stop at the first answers.  Uses creativity and ingenuity to develop solutions to complex problems, formulates strategies and approaches that may fall outside historical norms.
• Can deal with ambiguity and act without having the total picture, is able to effectively pose questions in order to "tease out" information required for decision-making. Can handle risk and uncertainty.
• Ability to represent the Market Planning function on commercial and cross-functional teams. Can negotiate skillfully in tough situations with partners and customers.
• Demonstrates persuasive written and verbal communication skills. Is effective in a variety of presentation settings. Is comfortable around, and influential with, higher management.
• Strong commitment to quality. Consistently and thoroughly reviews work for accuracy before sharing with a wider audience. Delivers final products that are well vetted and reliable.

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

Accountabilities:
• Innovate and develop tools and processes to improve standard work and efficiencies.
• Build relationships to influence and dissimulate PTQ strategies, processes, and initiatives.
• Proactively identify gaps and trends in quality and compliance in order to proactive prevent decrease in compliance for inspections.
• Be open to diverse opinions, ideas, and viewpoints to be in a position to make the best decisions, plan, and executions.
• Balance between customer service and compliance without sacrificing quality standards and quality of work.
• Establish and follow company policies and procedures.
• Maintain a state of inspection readiness.
• Provide input to the development of personal performance goals and departmental objectives.
• Establish work priorities to meet targets and timelines.
• Manage competing priorities and allocate, adjust, and optimize assigned resources when applicable.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Development and manage department and cross-functional initiatives.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Develop and train personnel and internal customers on relevant business processes.
• Mentor junior personnel serving as a subject matter expert (SME) on quality systems, processes and issues.
• Collaborate on and author department policies or guidelines.
• Make decisions that impact the goals and objectives of the department.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Be accountable for behaviors as described in companies Core, Common, and Critical Competencies.
• Perform any other tasks as requested by Management to support quality oversight activities

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

Scientist/Sr. Scientist (Department of Immunology)

The Department of Immunology in Genentech Research is seeking a highly motivated Scientist /Senior Scientist to lead an effort in developing novel therapies for the treatment of various autoimmune diseases with unmet medical needs. The successful candidate will head a research group with the mission to identify and pursue therapeutic ideas. The candidate will also lead the effort to translate these ideas to therapeutic approaches for clinical development through the collaboration with other groups and departments,. In addition, the candidate will perform cutting-edge research in immunology to discover novel pathways and mechanisms that contribute to the pathogenesis of diseases and will publish impactful papers on this research.

The Analytics Manager/Sr. Manager participates actively in Genentech’s commercial planning efforts by providing unbiased, objective quantitative data analyses to address critical business issues and to support strategic decision making for the company.  The Analytics Manager will utilize advanced analytical techniques to: 1) Increase understanding of effectiveness/ROI of all promotional efforts including sales force; 2) Mine and analyze longitudinal patient-level data to generate hypotheses for brand teams and to inform primary market research; and 3) Measure the impact of business unit and multi-product initiatives on product specific performance.  The Analytics Manager/Sr. Manager has a broad understanding of pharmaceutical data, including sales and claims data, and which source to leverage in order to answer business questions most effectively.  He/she works with MA&S and Brand team colleagues to understand business objectives and to apply analytics for marketing projects.  The Analytics Manager/Sr. Manager conducts critical analyses by integrating multiple data sources to provide an objective viewpoint and recommendations to the Commercial organization.  He/she utilizes SAS and advanced statistical techniques to:

MAJOR RESPONSIBILITIES:

1. Develop and implement standard ROI principles and analyses and present results to marketing teams (20%)
2. Develop and implement analyses for field force promotion, including customer segmentation, targeting, and promotional response measurements (20%)
3. Make recommendations to brands and other stakeholders on the effectiveness of different marketing tactics (10%)
4. Generalize approach to measuring common programs across the business unit (10%)
5. Establish and maintain data and approaches to measuring tactic interactions and cross-product impact (10%)
6. Partner effectively and collaborate with other MA&S colleagues to provide holistic analytical insight (10%)
7. Develop Marketing Mix models to optimize marketing spends. Create process for effective monitoring and decision making of marketing spends (10%)
8. Represent brand-specific MS approaches and customizations to the broader team to ensure consistency in MS across the portfolio; learn from others, and proactively share and seek out advice on approaches to complex MS situations (10%)

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

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

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

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

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

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