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453 jobs match your search criteria:
| Date | Job Title | Job Level | Location | |
|---|---|---|---|---|
| May 28, 2013 |
Sr. Scientific Manager- Small Molecule Formulation
The Department of Small MoleculePharmaceutics in Genentech Research and Early Development is seeking a highlymotivated Senior Scientific Manager to lead an effort in pharmaceuticalprofiling and development, during preclinical and early clinical assessment, ofnovel small molecule therapeutics for unmet medical needs. The successfulcandidate will head a small group of scientists, and is expected to:
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Experienced | South San Francisco, California | |
| May 28, 2013 |
Sr. Scientist- Clinical Pharmacology
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. ... |
Experienced | South San Francisco, California | |
| May 23, 2013 |
Sr. Scientist/Scientist - Electrophysiologist
We have an opening for a talented electrophysiologist to join our Biochemical and Cellular Pharmacology group as part of the small molecule drug discovery program in our South San Francisco location.
Responsibilities:
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Experienced | South San Francisco, California | |
| Apr 4, 2013 |
Sr. Scientist/Scientist- Oncology Biomarker Development
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:
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Experienced | South San Francisco, California | |
| Mar 18, 2013 |
Sr. Strategy Manager - Octreolin, Strategic Pricing & Contract Management
Sr. Strategy Manager The Sr. Strategy Manager, Strategic Pricing & Contracting develops pricing and contract strategies for the assigned segments that optimize the value of Genentech’s portfolio, which includes leading cross-functional segment strategy development teams, building effective relationships with account core teams, internal teams across MCCO (Managed Care & Customer Operations), scenario analysis/modeling for overall financial and legal viability, and ongoing pricing and contract performance assessment/analysis. This opening would be primarily focused on leading launch preparations for octreolin, a recently in-licensed compound for the treatment of acromegaly. Acromegaly is a disease affecting 20,000 people in the US. This is a long-term condition in which there is too much growth hormone present resulting in body tissues enlarging over time, ultimately leading to various co-morbidities and a shorter lifespan. We are excited about this opportunity for Genentech as we feel that octreolin could represent a significant advance for patients with this devastating condition. The potential launch timing is Q1, 2015. This supervisor role would oversee the Growth Franchise (Nutropin and Octreolin) and will have one or more direct reports and will also share some of the other departmental management activities with their manager, e.g., reviewing the work of other managers, developing training/development programs and initiatives for team members, preparing and delivering senior management presentations on strategic or complex issues, leading strategic projects, etc. Given the nature of this group’s work, most management and staff in this department have considerable responsibilities for regular communications, interactions, coordination and development with partners in the broader Roche organization, and communicating with, influencing, and securing approval from senior management.
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Experienced | South San Francisco, California | |
| Jun 3, 2013 |
Sr. Supply Planning/Inventory Management Specialist
The primary responsibility of this position will be to focus upon clinical product planning for multiple molecules; which includes partnering with Clinical Operations to translate trial assumptions into drug forecasts, utilizing SAP/APO to develop supply plans and to align these supply plans with the Technical Development Team, and partnering with Master Production Planners (MPP) to ensure plans are converted into bulk, filling, packaging, and contract manufacturing schedules which meet customer requirements. For Finished Goods, the CDSL is also accountable for generating a distribution plan to handover to the Global Clinical Distribution team and working with this group to ensure a seamless supply chain throughout our distribution network. The CDSL will be knowledgeable of the costs and capacities associated with our manufacturing network, and will assist the MPP in developing recommendations to balance production requirements, customer service, and manufacturing capacity. The CDSL will assist in the execution of our Clinical Demand & Operations Planning process, in capturing supply planning metrics and in developing/implementing strategies to drive improvement in those metrics; enabling the development of robust business processes and our ability to reach our department goals.
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Experienced | South San Francisco, California | |
| Feb 6, 2013 |
Sr. Technical Manager, Global Complaint Management
· Follow company policies and procedures and be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies · Lead product complaint investigations with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards. · Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems. · Develop solutions to complex product complaint issues and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards. · Ensure appropriate application & integration of cGMPs in the product complaints management system. · Set personal performance goals and provide input to departmental objectives. · Establish work priorities to meet targets and timelines and manage competing priorities/ · Serve as the Quality representative on cross-functional and multi-site teams. · Identify, design, and implement process and system improvements. · Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships. · Develop, train, and mentor personnel and internal customers on relevant business processes. · Collaborate and author department policies and procedures. · Make decisions that impact the goals and objectives of the department. · Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. · Inform management of critical product complaints and provide timely impact assessments of potentially affected products, materials or processes. · Review and approve product complaint investigation reports and supporting documentation. · Lead collaboration with departments to establish appropriate, efficient, and timely investigation strategies. · Educate departments on the best practices for conducting investigations and root cause analysis. · Lead project teams to resolve deficiencies identified through the root cause analysis process. · Assess the accuracy of root cause determinations based on a thorough evaluation of possible failure modes. · Present product complaint records and/or reports during periodic audits and regulatory inspections. · Perform any other tasks as requested by Management to support Quality oversight activities ... |
Experienced | South San Francisco, California | |
| May 23, 2013 |
Sr. Technical Manager, Tech Transfer – Biologic Drug Substances
(External Quality, Commercial Drug Substance) Sr. Technical Manager, Tech Transfer – Biologic Drug Substances (SSF) Main Purpose of the Position: * Provide Quality oversight for Roche and Genentech products manufactured at Contract Manufacturing Organizations (CMOs) to ensure compliance with cGMP regulations and Roche/Genentech standards. * Serve as the Quality single point of contact for designated CMO(s) and participate as a key member of Drug Substance (DS) CMO governance teams to support site selection, product technical transfers and on-going external commercial site management.
Responsibilities: * Participate in site selection and product technical transfer activities at CMOs, such as due diligence audits and GMP readiness activities. * Manage all required activities to support release of commercial product including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls. * Develop, negotiate and maintain CMO cGMP quality agreements and ensure compliance with agreements. * Develop/maintain quality risk management plans; utilize risk management tools to identify and mitigate CMO quality and compliance risks, ensuring CMO sites are in a state of continuous inspection readiness. * Participate in regulatory inspections and cGMP compliance audits, collaborating with CMOs to ensure on time closure of associated CAPAs. Support regulatory filings for products manufactured at CMOs. * Support creation of Annual Product Reviews, product complaint investigations, and other quality functions as required. * Establish CMO goals/metrics and monitor and report progress. Lead or participate in CMO or cross-functional process & quality improvements projects. ... |
Experienced | South San Francisco, California | |
| Jun 4, 2013 |
Sr. Technical Mgr. (Quality Change Control, Change Controller)
Main Purpose of the Position: Solve a wide range of challenging issues that impact multiple functions by managing change records in accordance to cGMP regulations and Genentech standards. Manage staff performing a variety of routine and complex change control activities to meet cGMP regulations and Genentech standards. Perform assigned tasks and manage performance and development of direct reports to ensure achievement of organizational and department goals objectives. Job Duties/Responsibilities: Manage and administer all aspects of people processes related to the employee life cycle. 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 goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities. Set operational objectives for staff. Follow company policies and procedures. Help maintain a state of inspection readiness. Lead and participate in improvements to Quality operational policies, plans and procedures. Manage routine department activities and complex Quality initiatives. Ensure completion of activities and initiatives on time and within budget. Serve as the Quality representative on cross-functional and multi-site teams. Identify, design, and implement process and system improvements. Lead and participate in the design and implementation of department and cross-functional initiatives. Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult 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. Train personnel on relevant business processes. Be accountable for behaviors as described in Roche’s Core Competencies. Technical Duties/Responsibilities: Function as a Change Controller by assessing, reviewing, approving and closing change records. Ensure the management of lot release restrictions imposed by system, process, method and equipment changes. Author, edit, word process, and release controlled documents relating to Quality Systems. Provide training to new employees and internal customers on policies and procedures for the Change and Document Control systems. Facilitate and contribute to cross-functional change management forums. Recommend change control strategies that have minimal impact of validated systems and qualified equipment. Lead business process improvement and process redesign initiatives. Collaborate with departments to ensure that all review activities are executed efficiently and effectively. Support periodic audits and regulatory inspections. Develop and implement systems to ensure inspection readiness. Provide data for departmental performance metrics. Serve as a Quality representative on cross-functional and multi-site teams. May be required to support other Quality Systems & processes such as Document Management, CAPA, Product Complaints, Annual Product Reviews. Support internal and partner audits, and health authority inspections....
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Team Leader | Hillsboro, Oregon | |
| Feb 5, 2013 |
Sr.Research Assoc - Protein Engineering
We are seeking an energetic and accomplished Research Associate/Senior Research Associate in Early Discovery Biochemistry within Genentech. Our group conducts early drug discovery and new target validation from a biochemical/physical, structural, and computational perspective and collaborates with diverse discovery biology areas in Genentech. The candidate must have excellent skills with directed evolution techniques, such as phage display, yeast display, and/or mRNA display. Preference will be given to candidates who also have experience in computational biology and/or biophysics. Projects will span a wide range of areas, and the candidate must be flexible, creative, and able to master new techniques as needed.
... |
Experienced | South San Francisco, California | |
| Jan 17, 2013 |
Staff Statistical Scientist
Global Product Development Biometrics Biostatistics (PDBB) at Roche/Genentech plays a key role in successful drug development by contributing expertise to the drug development process from research through entry into humans through regulatory approval and beyond. Biostatisticians collaborate on cross-functional teams with colleagues from Clinical Science, Safety Science, Regulatory Affairs, and other functions. Statistical Methods and Research is a group of statisticians within PDBB with a mission to enhance our strategic and methodological capabilities. Current areas include portfolio decision-making, quantitative benefit-risk, regulatory statistics, and personalized healthcare, but may be extended to meet business needs. Key responsibilities include: • Provide effective, timely and reliable consultancy across the company on statistical problems • Engage in research in statistics to improve clinical trial methodology used in the development of company products consistent with corporate priorities and timelines • Work in collaboration with Biostatistics leadership to identify and prioritize areas of potential impact that need new or improved statistical methods • Impact drug development science beyond the company in industry forums • Influence internal and external stakeholders to produce and implement robust drug development strategies • Contribute to ensure that PDBB is regarded as highly effective strategic partners in drug development whose prestige extends beyond the company • Develop and maintain expertise in at least one core area of biostatistics and serve as an advisor to other biostatisticians and PD leadership ... |
Experienced | South San Francisco, California | |
| Feb 15, 2013 |
Statistical Programmer Analyst
Statistical Programmer (SPA-2) Position Purpose: The Statistical Programmer has responsibility for statistical programming support for the Pharma Development, gRED, pRED, and/or EpiPRO organizations. He/she supports statistical programming teams on assigned study level activities in planning, designing, and implementing statistical software solutions for the reporting and analysis of clinical trials in accordance with applicable processes. Major Responsibilities and Accountabilities: Contributes to SPA team in preparing summarized information to clinical study team members Assist statistical programming activities at study level or components of a clinical project as applicable Able to access and clarify requirements, provide statistical programming solutions and ensure their efficient implementations under supervision Under guidance of a senior SPA, develops approaches to meet the study and project requirements Assist in determining and developing approach to technical solutions Responsible for accuracy and reliability of results. Builds and monitors quality in every aspect of job activities. Has an awareness and familiarity with the types of risks associated with a study and the impact on the quality of deliverables Is aware of timelines and scope based on resourcing / priority constraints within the SPA team and understand their implications on individual work assignments Builds and maintains effective working relationships with SPA team members. Adapts to changing circumstances, policies, work assignments, and/or team members. Able to multi-task and prioritize between tasks ... |
Experienced | South San Francisco, California | |
| Apr 24, 2013 |
Statistical Scientist - Nonclinical Biostatistician
Requirements:
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Experienced | South San Francisco, California | |
| May 31, 2013 |
Strategy Manager/Sr. Strategy Manager - Reimbursement Strategy, MC Marketing
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.
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Experienced | South San Francisco, California | |
| May 22, 2013 |
Strategy Manager/Sr. Strategy Manager, Strategy Pricing & Contract Management
This position may be filled at a Strategy Manager or Sr. Strategy Manager level. The Strategy Manager is responsible for maximizing the value of Genentech's portfolio through the development of integrated pricing and contracting strategies for a specific therapeutic area or product(s). The role involves leading cross-functional strategy development teams, building effective relationships across all GNE franchises, scenario analysis/modeling for overall financial and legal viability, as well as ongoing contract performance assessment/analysis. Position involves extensive cross-functional collaboration with brand teams, Market Planning, MCCO Account Managers, Government Affairs, Health Economics and Global Pricing and Payer Planning.
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Experienced | South San Francisco, California | |
| May 15, 2013 |
Strategy Manager/Sr. Strategy Manager, Strategy Pricing & Contract Management
This position may be filled at a Strategy Manager or Sr. Strategy Manager level. The Strategy Manager is responsible for maximizing the value of Genentech's portfolio through the development of integrated pricing and contracting strategies for a specific therapeutic area or product(s). The role involves leading cross-functional strategy development teams, building effective relationships across all GNE franchises, scenario analysis/modeling for overall financial and legal viability, as well as ongoing contract performance assessment/analysis. Position involves extensive cross-functional collaboration with brand teams, Market Planning, MCCO Account Managers, Government Affairs, Health Economics and Global Pricing and Payer Planning.
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Experienced | South San Francisco, California | |
| May 3, 2013 |
Study Data Manager (CDC II)
Clinical Data Management (CDM) is a department within the Biometrics function of the Product Development (PD) organization. CDM provides data management expertise to study management teams in PD and in gRED (Genentech Research & Early Development).
RESPONSIBILITIES:
The Study Data Manager (SDM) is a core member of Study Management Teams and serves as the study data management contact at the study and/or program level, providing expert guidance to program teams. The Study Data Manager leads the CDM study team and maintains oversight of all study start-up, study conduct and study close-out data management issues, activities and deliverables for one or more studies. The SDM interacts regularly with Clinical Data Management groups to ensure that project objectives are understood and met and provides technical coaching and mentoring on data management activities to colleagues. The SDM also performs the following: provides early strategic input into protocol design focused on data management issues; leads the development of eCRFs and database development and testing specifications by interacting with other functional area representatives; responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals; responsible for the implementation of standards within Study Data Management across one or more CDM study teams; develops and executes ad hoc database queries utilizing data review and query tools; manages projects resourced externally via contract research organizations or corporate partners; provides support to ensure that study conventions, processes, knowledge sharing and best practices exist across all studies within a program; participates in departmental discussion groups, formal working groups or special projects. ... |
Experienced | South San Francisco, California | |
| Jun 3, 2013 |
Study Data Manager (CDC II)
Clinical Data Management (CDM) is a department within the Biometrics function of the Product Development (PD) organization. CDM provides data management expertise to study management teams in PD and in gRED (Genentech Research & Early Development).
RESPONSIBILITIES:
The Study Data Manager (SDM) is a core member of Study Management Teams and serves as the study data management contact at the study and/or program level, providing expert guidance to program teams. The Study Data Manager leads the CDM study team and maintains oversight of all study start-up, study conduct and study close-out data management issues, activities and deliverables for one or more studies. The SDM interacts regularly with Clinical Data Management groups to ensure that project objectives are understood and met and provides technical coaching and mentoring on data management activities to colleagues. The SDM also performs the following: provides early strategic input into protocol design focused on data management issues; leads the development of eCRFs and database development and testing specifications by interacting with other functional area representatives; responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals; responsible for the implementation of standards within Study Data Management across one or more CDM study teams; develops and executes ad hoc database queries utilizing data review and query tools; manages projects resourced externally via contract research organizations or corporate partners; provides support to ensure that study conventions, processes, knowledge sharing and best practices exist across all studies within a program; participates in departmental discussion groups, formal working groups or special projects. ... |
Experienced | South San Francisco, California | |
| Mar 18, 2013 |
Supervisor, Access Solutions
Supervisor
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Experienced | South San Francisco, California | |
| May 31, 2013 |
Supervisor, Mfg-BioProcess CHO CCM - Shift N2
Supervisor1/ Supervisor 2
RESPONSIBILITIES: Ensure success of operations on a day-to-day basis. Direct, plan, organize and control operations. Primarily responsible for ensuring required levels of safety, quality, and productivity are met. Support Operations by working effectively within the management team to execute goals, objectives, and tasks to achieve desired results. Direct shift operations by planning, prioritizing tasks and assignments, and deploying resources in alignment with the production schedule. Provide leadership and technical oversight to staff members. Develop and/or improve staff capabilities in response to department needs and expectations. Provide cross-functional coordination and issue resolution across operations, other groups and/or projects. Anticipate potential problems or vulnerabilities in processes or systems and suggest solutions. Manage the implementation of solutions to increase efficiency and effectiveness of the shift towards meeting department goals.... |
Manager with Direct Reports | South San Francisco, California |
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