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452 jobs match your search criteria:
| Date | Job Title | Job Level | Location | |
|---|---|---|---|---|
| Apr 24, 2013 |
Statistical Scientist - Nonclinical Biostatistician
Requirements:
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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 | |
| 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 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.
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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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 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 | |
| Mar 27, 2013 |
Sr. Safety Scientist (MD) - Oncology
Position:Safety Scientist
JobPurpose: The Safety Scientist is responsible for carryingout pharmacovigilance activities on a product or group of products, includingsingle case processing, aggregate reporting, signal detection and evaluation ofPV database. The Safety Scientist supports the Safety Science Leader andis responsible for a particular aspect(s) or segments of the overallprogram. He/She contributes to the benefit risk evaluation and tosafety risk management.
PrimaryResponsibilities and Accountabilities: Carry out pharmacovigilance and risk managementactivities for specific product or products: · Contribute to Pharmacovigilance and RiskManagement planning for designated products by preparation of safetysurveillance strategy and highlighting and tracking potential issues · Prepare and review periodic safety reports(PSUR, EU Annual Safety Reports) in accordance with regulatory requirements andPDMS standard operating procedures · Coordinate safety activities between PDS andinternal and external partners
Carry out signal detection activities andevaluation: · Conduct/support signal detection and evaluationaccording to SOPs and guidelines · Carry out medical review of spontaneous casereports and Serious Adverse Event reports from clinical trials, according toSOPs and guidelines · Prepare Drug Safety reports, as necessary, forpotential signals · Respond to queries relevant to the safety ofRoche products from the affiliates and other internal functions
Contribute drug safety input to activities to defineand implement the Clinical Development strategy for a product or group ofproducts: · Provide review of clinical protocols and studyreports to ensure alignment with CDP and safety adequately addressed, andcontributes to the safety section of the Investigators Brochure (IB) Contribute to regulatory authority submissions(NDAs, MAAs, Variations) by reviewing safety data and preparing relevantsections of the submission... |
Experienced | South San Francisco, California | |
| May 23, 2013 |
Sr. Quality Specialist
• Manage Quality system for change control and document management functions for GMP changes involving equipment, documents, test methods, processes and specifications for IMP Small Molecule and Biologics operations. |
Experienced | South San Francisco, California | |
| May 15, 2013 |
Sr. Quality Manager
The Senior Quality Manager is responsible for proactively ensuring that all GCP governed clinical activities in PDG (Product Development Operations) are delivered to the highest standards of quality and efficiency in accordance with the appropriate Roche and industry requirements and regulations.
The Senior Quality Manager leads quality and compliance excellence within PDG by embedding quality principles throughout the organization. This is achieved through:
Quality Management System - Analyze and drive the QMS requirements for PDG and Implement, review and manage the QMS and monitor its performance. Ensure cross functional alignment and compliance through process documents - Analyze/review “to be” processes, forms, templates and related process documents. Coordinate the functional subject matter experts by scheduling review and implementation of new/revised process documents and develop and maintain effective relationships with other departments to ensure that all controlled document review activities are executed efficiently and effectively. Risk management strategy - Implement, review and maintain strategic quality risk management activities and implement, review and maintain systems that enable identification of key risks for escalation to study teams and senior management. Performance metrics - Implement, review and report the most appropriate key performance indicators (KPIs) for the business and monitor their effectiveness Implement, review and maintain processes that enable oversight for PDG management and personnel on the metrics which give performance data on the chosen KPIs. Compliance support - Drive the compliance support process for PDG in order to create a compliant workforce and workplace based on Regulator’s requirements. Provide timely GCP and process compliance support to personnel by answering questions and providing advice manage the process for escalation of compliance issues through the appropriate routes and with appropriate urgency. Additional duties and responsibilities:
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Experienced | South San Francisco, California | |
| Apr 26, 2013 |
Sr. Quality Engineer - IMP Quality Assurance
• Provide QA oversight, support and execution of validation/qualification activities pertaining to Investigational Medicinal Products (IMP, a.k.a. clinical) GMP manufacturing equipment and analytical instruments, including preventive maintenance and requalification activities. |
Experienced | South San Francisco, California | |
| Jun 4, 2013 |
Sr. Project manager, PDR
Position Purpose:
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Manager | South San Francisco, California | |
| Apr 16, 2013 |
Sr. Project Mgr, PMO (gRED)
We are seeking a Sr. Project Manager who will manage complex projects to successful and timely decision points from Late Stage Research through Proof of Concept. The Sr. Project Manager will actively contribute to the definition of project strategy and guide the project core and sub teams to deliver on project objectives. This position will be accountable for steering drug development teams through corporate processes. Additional responsibilities include but are not limited to the following:
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Manager | South San Francisco, California | |
| Apr 16, 2013 |
Sr. Project Mgr, PMO (gRED)
We are seeking a Sr. Project Manager who will manage complex projects to successful and timely decision points from Late Stage Research through Proof of Concept. The Sr. Project Manager will actively contribute to the definition of project strategy and guide the project core and sub teams to deliver on project objectives. This position will be accountable for steering drug development teams through corporate processes. Additional responsibilities include but are not limited to the following:
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Manager | South San Francisco, California |
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