Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness.  Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer.  Performs media/buffer solution preparation operations.  Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).  Responsible for being proficient in two or more functional areas and applies expert knowledge of mechanical, scientific principles, processes and biopharmaceutical processing equipment.

 

Job Responsibilities

Essential

• Provide coaching and training on best practices and compliance to SOPs.

• Prepare solutions for the production process.

• Participate in continuous operational improvement.

• Provide reports to management summarizing goal unit attainment.

• Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

• Understands the theory, concepts, and regulations behind biopharm technology and processes. 

• A strong knowledge of at least one manufacturing department with an understanding of process impact of other areas.

• Anticipates potential problems and takes preventative action.

• Requires judgment to know when it is necessary to consult with supervisor and/or support groups. 

• Understands how own actions impact others and uses this information in decision-making.

• Operate systems that clean and sterilize tanks and filtration systems. 

• Prepare solutions for the production process.

• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).

• Trouble shoot equipment and process problems.

• Comply with safety requirements, cGMP, SOP and manufacturing documentation.

• Use of automation to perform production operations.

• Provide support to Manufacturing to meet production demands.

• Operate automated systems for equipment operation.

• Assemble and prepare equipment for production.

• Exhibit detail oriented documentation skills.

• Communicate effectively and ability to work in a team environment.

• Exhibit professional interpersonal skills.

• Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities

• Operate fermenters, centrifuges, other harvest systems and protein purifications units.

• Operate and clean fixed tank and filtration systems.

• Operate large scale column chromatography systems.

• Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch reefed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.

• Perform CIP and SIP.

...

Market Planning Manager, Oncology - Global Product Strategy

Participate actively in global commercial planning efforts by providing objective, in-depth analyses on current and future markets, product performance, customers, and competitors. Additionally, identify critical business issues and opportunities for growth, collaborate with Genentech/Roche teams, and work to embed an external market point-of view into the strategic direction of the company.

This Global Market Planning Manager / International Business Analyst position is a global role based in South San Francisco. This individual will be a member of a global cross-functional team focusing on development of our pipeline products and will be required to travel domestically and internationally.

KEY ACCOUNTABILITIES:
*Proactively and continuously assess the relevant marketplace and its dynamics, customers and competitors to enable strategic decision making regarding brands and business operations.
*Business partner within assigned cross-functional teams: developing strategic insights and providing in-depth product and marketplace knowledge.
*Ensures alignment across internal partners, stakeholders, and senior management.
*Leads initiatives to facilitate growth and development of the Global Strategic Analytics team
*Responsible for new market and product opportunity assessments.
*Creates, manages, validates, and refines forecasts (product and market)
*Communicates revenue forecasts and assumptions to internal partners, stakeholders, and senior management.
*Develops and implements market research plans, in conjunction with cross-functional teams.
*Provides analytical input to the Disease Area Director during due diligence for in-license opportunities and liaises with partnering groups.
*Actively contributes to cross-functional or other project teams, helping the overall business evolve, improve & excel.
...

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.

...

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%)

...

Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of cGMP production equipment, clean utilities and plant utility systems. Assist with engineering and evaluation of existing and new equipment and processes. This is a Journeyman level position.

• Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
• Conduct routine inspections and monitoring of equipment and systems and documenting systems operating parameters.
• Make appropriate adjustments or modifications within company and GMP guidelines and notify supervisor of any abnormal parameters.
• Lead and organize specialized maintenance and equipment projects. Includes research of methods and devices, assisting with implementation and documentation of change control.
• Provide general labor services throughout all areas maintained by the Maintenance department.
• Responsible for providing data to derive performance metrics for management that will be gathered on a daily basis for monthly reporting.
• Provide technical expertise and training to junior staff.
• Assist as technical SME with identification, purchase, and organization of spare parts.
• Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on manufacturing and utilities equipment.
• Cleaning and organization of designated work areas in Manufacturing and Utilities.
• Complete GMP and other controlled documentation.
• Revise or modify existing SOP documentation as necessary and be expected to write new procedures for new equipment and other duties as assigned by management.
• Interact with Manufacturing, Instrumentation, Metrology and Engineering staff members as well as other internal/external customers.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

...

Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of cGMP production equipment, clean utilities and plant utility systems. Assist with engineering and evaluation of existing and new equipment and processes. This is a Journeyman level position.

• Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
• Conduct routine inspections and monitoring of equipment and systems and documenting systems operating parameters.
• Make appropriate adjustments or modifications within company and GMP guidelines and notify supervisor of any abnormal parameters.
• Lead and organize specialized maintenance and equipment projects. Includes research of methods and devices, assisting with implementation and documentation of change control.
• Provide general labor services throughout all areas maintained by the Maintenance department.
• Responsible for providing data to derive performance metrics for management that will be gathered on a daily basis for monthly reporting.
• Provide technical expertise and training to junior staff.
• Assist as technical SME with identification, purchase, and organization of spare parts.
• Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on manufacturing and utilities equipment.
• Cleaning and organization of designated work areas in Manufacturing and Utilities.
• Complete GMP and other controlled documentation.
• Revise or modify existing SOP documentation as necessary and be expected to write new procedures for new equipment and other duties as assigned by management.
• Interact with Manufacturing, Instrumentation, Metrology and Engineering staff members as well as other internal/external customers.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.
• General Duties: Master Level PM and Repairs of process equipment and systems such as Fermentors, Centrifuges, Mixers, Autoclaves, Washers, Pumps, Agitators, Mechanical Seals, Control Valves, Steam, Hydraulics, Pneumatics, Electrical Controls, Chilled Water, High Purity Water, Compressed gases etc.

...

Medical Communications Scientist is able tocommunicate relevant, timely, accurate, and balanced clinical information onGenentech's products, positively influencing their safe and effective use.

 

DESCRIPTION:

The Medical Communications Scientist is able tocommunicate relevant, timely, accurate, and balanced clinical information onGenentech's products, positively influencing their safe and effective use. Ableto evaluate medical literature as well as write, review, edit, and approvemedical content to ensure appropriate clinical context and accuracy. Providesmedical responses through various communication channels (response documents,web-based media, scientific meetings, etc.). Is also able to provide trainingrelevant to Genentech's product portfolio. Has a basic understanding oflegal/regulatory topics adequate to describe the basis of Medical Affairspolicies and procedures, and applies this knowledge to the review ofpromotional materials and Medical Affairs documents.  The Medical Communications Scientist is able to assist in the development andimplementation of Medical Communication policies and procedures, establish andsupervise the work flow for delegated projects, and assess incoming requestinformation to determine required action and triage based on internal policiesand procedures. Can convey and acquire medical information as well ascommunicate and work effectively with members of the Medical Communicationsstaff and customers which include but are not limited to: Sales, Marketing,Managed Care, Clinical Development, Product Safety, Regulatory, Legal, andCorporate Partners.

...

Purpose

To provide relevant, balanced, and timely evidence-based clinical information on Genentech products to managed care customers that make decision regarding drug coverage and reimbursement, .

Description

The Associate Scientist or Scientist for Managed Care Medical Communications (MCMC) is able to communicate relevant and timely clinical information on our marketed products and compounds in late development.  More specifically, this position is responsible for communicating effectively with external customers involved in evidence-based healthcare decisions including but not limited to managed care organizations, private and government health plans, third party payors, pharmacy benefit managers, specialty pharmacies, compendia publishers, guideline bodies and technology assessment entities.  The MCMC Associate Scientist/Scientist is expected to evaluate and interpret medical literature, abstract and write medical information in various response formats, conduct scientific and clinical presentations, and apply managed care concepts and knowledge to customize our services for managed care customers.  More specifically, an understanding of the comparative effectiveness research (CER) and health technology assessment (HTA) landscape is required, as well as the ability to review, assess and synthesize CER, health outcomes research and pharmacoeconomic evidence.  Medical information is prepared and communicated using many formats (response documents, formulary dossiers, slide presentations, compendia submissions, web-based media, scientific meetings, etc.).  This position is also involved in the review of promotional marketing materials intended for the managed markets and payor environment.  The MCMC Associate Scientist/Scientist shall effectively, appropriately, and responsibly use resources to support the use and access of our marketed products.  

The MCMC Associate Scientist/Scientist may contribute to departmental efforts to develop, implement or further improve business processes and operations.  This may include non-clinical and non-product types of responsibilities and activities such as systems and technology, training, quality assurance, writing policies and procedures.  Some business travel is expected.

Candidates should have a sound understanding of legal and regulatory topics to adequately describe the basis of Medical Communications (MC) policies and practice.  He/she must work effectively with members of the MCMC/MC staff and other internal customers that include but are not limited to: Medical Directors, Health Economics and Outcomes Research, Managed Care Liaisons, Project and Execution Managers, Regulatory, Legal, Managed Care Marketing, Field Managed Care, Medical Science Liaisons, Sales, Marketing, Access Solutions Reimbursement, and Corporate Partners.  This position shall partner with these entities to meet the information needs of managed care customers, contribute to corporate wide goals, and support the safe and effective use of Genentech products.

...

  Manages the implementation of Medical Data Review, both processes and application of the tools by Clinical Scientists, by providing on-site training, development of best practices, and dedicated support.  The person in this position optimizes the implementation of Medical Data Review by being an integral member of the MDR support network.

 

Main Responsibilities:

Provides training for medical data review tools

• Owns the scheduled training program and ad hoc on-the-job training
• Provides class room training/ one on one training as required
• Assists with the access process to medical data review tools and provides guidance
• Ensures tool users understand the data source(s) used for report generation, and assists with identification of questionable or discrepant content (includes some UAT)
• Contributes to the co-ownership of the standard training materials for MDR tools (e.g. J-Review)
• Co-develops applied job aids to support end users in use of the tools (e.g. tips and tricks sheets)
• Maintains real-time training attendance records
• Updates materials as systems undergo changes and alerts end users of changes as they occur

 

Provides support for medical data review

• Acts as a main point of contact for Clinical Scientists with questions on Medical Data Review processes and documentation
• Acts as the main point of contact for CDM report developers and Informatics (e.g. for specification set up and UAT)
• Acts as a main point of contact for teams engaging with CROs for MDR of external data and champions the standards used with vendors
• Provides guidance and actually develops ad hoc report objects to support ongoing MDR
• Actively solicits input from users to identify areas requiring additional support

• Delivers desk-side first level system support to end users, and understands when resolution requires escalation

• Participates in meetings with tools’ owners to ensure end users requirements are met
• Co-maintains an on-line PDC communication/document repository

 

Tracks system compliance

• Monitors tracking reports for tool compliance and performance of reports
• Reviews and provides the Informatics team with regular updates on status and metrics using standard/automated reports

 

Provides input into the global development of best practice for MDR

• Promotes knowledge sharing across the Function and within Therapeutic Areas to improve MDR best practice
• Provides input into the development of best practices of MDR Tool use and advises on the optimal use of standard tools and templates
• Proactively gathers change requests for new/different report objects or changes in processes or standard templates
• Supports the set up and maintenance of report objects built per study for medical data review
• Encourages and champions standard report objects wherever possible (cross program/TA)
• Proactively incorporates learning and recommendations from users
• Contributes to activities for improving and maintaining the quality and effectiveness of tools within Clinical Science.
• Participates in local and/or global initiatives that focus on the tools
• Makes recommendations for improvements to Informatics and Developers
• Partners with end users in proposing creation/revision of report objects
• Uses Informatics, Developers of tools for information and knowledge based resource
• Shares information across the MDR Specialist team and MDR Network
• Maintains oversight of external available tools and functionality

System support management

• Reviews and approves relevant System Development Life Cycle documents
• Contributes to future upgrades and assessment for improvements, new releases, replacement software
• Provides proactive support in terms of communication regarding updates and best practice

...

As the Medical Director you willbe responsible for the design, implementation, monitoring, analysis, andreporting of studies conducted within the Late Development Oncologyorganization. You will also participate in developing the long-range strategicplans for the molecule or molecules within the area of Oncology.

 

Key Accountabilities:

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

Participation in on-going medicinedevelopment activities including:

•  Preparation of regulatory documentsand interaction with global regulatory authorities

•  Monitoring and reviewing incomingdata

•  Analysis, presentation andinterpenetration of on-going studies and published data

•  Interactions with health authoritiesand expert bodies

•  Close collaboration with drugsafety, regulatory affairs, medical affairs and clinical trial operations

•  Participation in the preparation ofabstracts, posters and presentations for scientific meetings and congresses

•  Developing and writing clinical plansand protocols ensuring that they are scientifically sound

 

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

•  Solid experience in medical research includingwriting clinical study reports and interpreting clinical data

•  Good communication and collaborativeskills with experience at working with cross-functional and external groups,including researchers, clinicians and other stakeholders.

•  Proven track record of delivery ofexperimental or novel studies

Confidence at presenting at internaland external strategy meetings

...

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

...

Genentech's Medical Affairs organization' mission is to serve as the bridge between clinical development and clinical practice to support the appropriate utilization and access to all our medicines, by generating and communicating compelling scientific evidence with healthcare professionals and payers. 

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

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

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

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

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

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

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

Technical/Functional Competencies 

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

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

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

• Comprehensive understanding of product and safety profiles

Core Competencies / Other Key Behaviors

 

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

• Scientific leadership 

• Leading Teams

• Collaboration and Teamwork 

• Excellent Judgment and Analytic skills 

• Drive for Results

• Effective Communication 

• Integrity

• People Development 

...

MEDICAL DIRECTOR/MEDICAL DIRECTOR - 

 

RESPONSIBILITIES:

Genentech is seeking a Medical Director with clinical and drug
development experience within our Development-Immunology organization. This individual will be responsible for strategic clinical
oversight with a focus on our scleroderma portfolio. The position will involve clinical development of novel agents. The Medical Director will be responsible for the design, implementation,
monitoring, analysis, and reporting of studies conducted within one or more programs.
They will also participate in developing the long-range strategic plans for the molecule or molecules.

...

MSL-Oncology

The states covered are Arizona, New Mexico, San Diego, Orange County, and Southern Nevada

Main Purpose of the Position:
The Genentech, Inc., Medical Science Liaison (MSL) functions as a field based member of the Medical Affairs organization. MSLs are scientifically trained professionals with strong clinical and / or scientific backgrounds. MSLs are expected to facilitate and implement the clinical strategies of Medical Affairs through:
* Relationship development
* Clinical trial support
* Scientific/clinical education and communication

 

Job Duties/Responsibilities:

General:
*Adhere to corporate compliance in all activities, including those related to clinical trials, scientific presentations, and responses to unsolicited requests for information.
*Maintain clinical, scientific, and technical expertise in specific therapeutic areas; review scientific journals, attend scientific and key technical meetings.
*Represent the Medical Affairs organization to investigator community
*Maintain ongoing long-term collaborative relationships with investigator and thought leader communities

 

Clinical trial support: MSLs interact with Genentech Medical Directors and their designees to determine and coordinate health care practitioner, researcher, and investigator activities.. MSLs act as the conduit between external customers and the Genentech Medical Directors.

 

Customer/Investigator support:
*Respond to and document unsolicited requests for information on our marketed products and products in clinical development
*Represent Genentech products at medical information exhibits during scientific symposia.
*Facilitate investigator and thought leader interactions with GNE Medical Directors

 

Commercial support:
*Provide internal clinical input and training to Commercial functions within regulatory guidelines
*Provide clinical and scientific support for Advisory Boards
*Content development/scientific review of content and presentation materials, upon request

...

 

 

Responsibilities: This position is for a Validation Engineer I/Manufacturing Technical Specialist I - Validation reporting to a Manager of Technology Validation in the South San Francisco Production Technology Department.  The candidate will be responsible for Validation scope supporting the South San Francisco manufacturing plants.  This includes drafting and execution of validation protocols, authoring validation and technical reports and development of project plans.  In addition, the candidate will support technical assessments for quality impact and participate on quality investigation teams.  The candidate will also monitor maintenance of the validated state of basic and some complex equipment and processes.  This includes monitoring operations and resolving moderate validation issues.  The candidate will support introduction of clinical products into manufacturing by participating on campaign/product planning teams and delivering the appropriate validation activities consistent with project timelines.  The candidate may lead cross functional teams or projects.  The candidate will be expected to work effectively in teams, to influence others to generate support for assigned activities or projects and to justify goals to department colleagues.  They will also act as a mentor for those with similar or less validation expertise.

...

Adhere to all plant safety policies and procedures and proactively identify unsafe conditions
Perform safety and housekeeping audits as required.
Assist in set up, change over, and test run equipment for various-sized vials and packages as required.
Supporting the Operations Specialist, Maintenance, and/or outside services in the repair, maintenance, and calibration of Genentech systems as required.
Perform training of other Technicians.
Assist in the development of plant SOP's and training materials
Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
Operate all formulation, sterile filling, inspection, and final vial packaging equipment in the plant.
Perform material handling in the plant as required.
Perform preparation of sterile components.
Assist in the cleaning, set-up, sterilization, and disassembly on a variety of processing equipment.
Perform bulk thaw, dilution, and formulation operations.
Performing manual inspection of empty vials and filled product with a focus on quality and efficiency.
Conduct environmental monitoring activities in the manufacturing areas as required.
Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs,
Process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency.
Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
Perform cleaning and housekeeping duties as required....

The Network Services Operations team is responsible for project deployment and 24x7 operations support of our North America enterprise wired and wireless networks which serve over 22,000 users and are comprised of wireless access points, switches, routers, firewalls, load balancers, proxies, VPN concentrators, and optical network devices.  

We are looking for a results-driven analytical thinker with strong technical and process management skills who can provide imaginative, thorough, and practicable technical solutions to a wide range of difficult problems.  This person will work closely with our architecture and engineering teams as well as vendors to maintain 99.99% availability while successfully deploying emerging network technologies to new and existing Genentech buildings and data centers.

Candidate must have good business acumen and possess strong communication and teamwork skills.  We are looking for an individual with strong time management skills who can work autonomously making sound decisions that are consistent with organizational objectives.  You must have a proven track record for delivering excellence thus enabling us to meet the scientific demands of our biotechnology revolution in information technologies.

...

Summary of Position:

The non-interventionalprogram (NIP) Coordinator is the specific point of contact for requestsregarding NIPs.  The NIP Coordinatorensures that all NIPs conducted by Genentech are approved, tracked, andconducted in accordance with relevant regulations and company internalprocesses and procedures.

 

Job Duties/Responsibilities:

• Liaison with the BusinessUnits to ensure a proactive review and assessment of all proposed NIPs.
• Provide support to scopestaff handling NIPs by answering questions or providing advice on good NIPpractices as defined in laws & regulations, codes and internal guidelines& SOPs
• Ensure timely involvementof line management in case of violation of good NIP practices
• Create and maintaintraining for good NIP practices, regulations, codes and internal guidelines& SOPs
• Ensure scope staffawareness of ongoing changes to regulatory or local requirements, and new proceduresand policies on NIPs. Co-ordinate in-house and external provider training byliaising with other departments, external trainers, or running courses,including functional orientation/induction program for new employees
• Identify the need forcreating additional or updating existing SOPs or processes/working guidelineson good NIP practices
• Responsible for tracking of NIPs under their scope of responsibilityinto NIP database(s)
• Ensure each NIP has a program outline which details the nature of the program and safety data collection and reporting processes
• Proactively reportsconcerns/issues to the NIP Coordinator Lead toensure compliance with safety SAE and non-serious AE reporting requirements are met
• Ensure a quality control and reconciliation process is in place for on-goingNIPs and conduct a NIP risk assessment at least once a year as per globalSOP(s)
• Liaise with other NIPcoordinators and be a proactive member of the global NIP network (identify newNIP requirements, develop preventive and corrective measures against NIP risks,maintain and promote good NIP practices across GPS and affiliates)

...

E4/E5

The purpose of the role is to provide high quality evaluation and sourcing of oncology, hematology, and tumor immunology opportunities.  This individual will also lead confidential due diligence evaluations and pursue BD licensing and partnership opportunities.

Job Duties/Responsibilities:

Responsible for screening potential oncology collaboration opportunities.

Lead more detailed diligence on selected high priority deals as part of diligence teams.

Provide effective liaison with Early Clinical Development.

Serve as a member of the Oncology Portfolio Committee.

Proactively source appropriate opportunities for GNE consideration from academic, literature, trade publications, meetings, etc.

Education of other BD professionals, including reviews of technical literature.

As appropriate, pursue BD licensing and partnership opportunities.

...

The Informaticsteam is looking for a highly skilled Operations Lead, who will support the systemsthat enable the Sales & Marketing business teams.  In this role you will work closely with thebusiness leads, end user community, development teams, vendors and serviceproviders to provide the overall IT service. As service lead, the individual may also play other roles as requiredlike project manager and business analyst to ensure optimal service delivery.  This candidate will be proactive, outgoing and detail-orientedwith excellent problem solving and written/verbal communication skills.  The Operations Lead will have excellentcustomer relationship management skills with a service minded attitude and abilityto translate informatics terminology into business relevant language

 

Further responsibilities are:

• Supports day-to-day operations and / or implementation of projects within area of technical expertise, contributes to and executes implementation plans
• Manages incident and problem management processes as well as release and configuration management.  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 leads
• Administers change control procedure and processes. This includes the management of the change control board and oversight of approved changes
• Is well versed in vendor management and can look for new opportunities to optimize our vendor contracts and relationships
• Applies complex procedures and defined standards to meet business, customer and technical requirements and leads others in resolution of complex problems
• Leads specialist resources on technical issues within the domain and provides detailed analysis of the operations and opportunities for improvement
• Develops business/technical critical know-how within area of expertise.  Assists in the development of others know-how by passing on knowledge of tools and techniques
• Accountable for rollout of new services and enhancements to existing services
• Familiar with Statement of Work (SOW) and procurement processes
• Tracks problems/issues to resolution with the appropriate level of follow-up with the user community
• Participate in project teams to help identify solutions and requirements for new functionalities and performing impact analysis
• Builds and maintains good working relationships with the business leads and the user base, monitors services and provides regular service reports to Informatics and business leads

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