RESPONSIBILITIES:

A Scientist or Sr. Scientist position is being offered to a highly motivated, qualified candidate to join the Marketed Product Support Group in the Late Stage Pharmaceutical Development Department. The position is Responsible for manufacturing site transfer and line extensions for the Genentech legacy biologics drug products, serves as technical subject matter experts for Quality investigations related to manufacturing and customer complaints, contributes to the relevant regulatory filings, supports the Quality organization during health authority inspections and for commercial control system upgrades.

The individual will participate in multi-functional product technical teams and will work closely with personnel within and outside the Late Stage Pharmaceutical Development Department.

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The Clinical Pharmacology Department at Genentech, Inc. is seeking a Ph.D. level Scientist who is driven to understand the clinical pharmacokinetics and pharmacodynamics of novel drug candidates in the areas of Oncology, Immunology and/or CNS . This individual will be responsible for the clinical pharmacology activities of delivering Small Molecules in clinical development. In addition to having responsibility for the Clinical Pharmacology strategy to ensure that appropriate dose, route, and schedule decisions are made using the state of the art modeling and simulation approaches. This will be accomplished by working in close partnership with Clinical Science, Clinical Operations, Regulatory, Biostatisticians and other functions which make up project teams. Other responsibilities will include planning and reviewing study designs, PK/PD data analysis and interpretation of analysis, as well as planning, preparation and implementation of clinical pharmacology sections, and organization of regulatory filings (worldwide). Clinical Pharmacologists at Genentech often present data at cross-functional teams, department meetings, conferences and regulatory global health authority meetings (worldwide). Additionally, this individual will also be directly involved in leading interdisciplinary sub project teams and representing the function at cross-functional project teams.

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The DMPK group is dedicated to enabling the discovery, developmentand commercialization of safe and effective medicines by elucidating theabsorption, distribution, metabolism, excretion and pharmacokinetic propertiesof small molecule drug candidates. We accomplish this through the applicationof state of the art technologies and sciences of bioanalysis, drug metabolism,drug transport and pharmacokinetics. The DMPK group works in close partnershipwith disciplines such as medicinal chemistry, pharmacology, toxicology,pharmaceutical sciences, clinical pharmacology and regulatory to optimizeleads, select clinical candidates, conduct preclinical development studies,support clinical evaluation and contribute to IND and NDA filings.

We are seeking a candidate to support both in vitro and in silicoADME.  The candidate will work with anestablished team on various in vitro assays and will collaborate with otherscientists in the group to perform hypothesis-driven studies to address ADMEquestions.  On the in silico side, thecandidate will apply ADME models to support projects and maximize the value of existingADME data. They will work at the intersection of modeling ideas, modelgeneration and experimental investigation to support/build SAR and meet projectneed.  A key part of the role will becontinuing education in the department on use of predictive DMPK and championinguse of in silico tools. The candidate will be a highly effective and energizingcollaborator and will work scientists from multiple disciplines including computationaland medicinal chemistry, safety assessment and pharmaceutical sciences.

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The Department of Safety Assessment at Genentech provides scientific leadership and plays an active role in the process of drug development from the discovery period through marketed products.

 

We are seeking a Scientist in the Department of Safety Assessment to support drug development. This role will involve working in a collaborative team environment as part of the comprehensive safety assessment of Genentech therapeutics by providing toxicology representation to biotherapeutics programs.

 

Responsibilities:

Successful Scientist candidates will provide scientific leadership and play an active role in the process of drug development from late-stage discovery through marketed products. Working in a collaborative team environment, the Scientist/toxicologist leads the safety assessment of Genentech therapeutics by creating a best-evidence synthesis of existing knowledge and comprehensive investigations of toxicologic activity. The successful candidate will design and supervise toxicology studies to support the goals of biotherapeutics project teams, work closely with Study Monitors, Pathologists and Pharmacokineticists to deliver high quality GLP and non-GLP in vivo study reports and, as needed, represent Genentech in meetings with regulatory authorities. Responsibilities include interdisciplinary project team membership, preparation and review of regulatory documentation, study reports and manuscripts, participation in toxicology and pharmacology initiatives, and other active cross-functional collaborations. Additional responsibilities include investigations into mechanisms of toxicity, proactive management of potential safety liabilities and communication of impact to teams and governance committees. Experience with cross-functional teams and capability to build productive cross-functional collaborations both within and external to Genentech are desired. In addition to activities listed, Senior Scientist candidates will provide independent leadership in the design and implementation of safety assessment strategies for Genentech’s project portfolios and lead or provide support to interdepartmental and cross-industry initiatives. May provide supervision, mentoring, and career development to toxicologists.

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Position description and responsibilities:

A position is available in the Protein Analytical Chemistry department for a Scientist with appropriate analytical skills and biopharmaceutical industry experience. The candidate must have strong understanding and hands-on experience in analytical characterization of recombinant therapeutic proteins, development of quality control methods, and application of emerging analytical technologies. The candidate should have experience in or be highly familiar with the development of analytical methods covering a wide array of techniques such as HPLC, CE and mass spectrometry. The Scientist will design and execute analytical characterization studies to identify critical quality attributes for each product. A strong understanding and knowledge in analytical control strategy development and cGMP is highly desirable.

The Protein Analytical Chemistry department is part of Genentech's Pharma Technical Development Biologics organization and is responsible for method development and detailed structural characterization of recombinant proteins to support the clinical and commercial biotechnology product portfolio.

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A position is available in the Protein Analytical Chemistry department for a Scientist with relevant analytical skills related to the biopharmaceutical industry. The candidate must have strong knowledge and hands-on experience in analytical characterization of recombinant therapeutic proteins, development and validation of quality control methods, and application of emerging analytical technologies. The candidate should have experience in or be highly familiar with the development of analytical methods covering a wide array of techniques such as HPLC, capillary electrophoresis (CE) and mass spectrometry. The Scientist will design and execute analytical characterization studies to identify critical quality attributes and enable a commercial control system for a late stage product. A strong understanding and knowledge in analytical control strategy development and cGMP is highly desirable.

The Protein Analytical Chemistry department is part of Genentech's Pharma Technical Development Biologics organization and is responsible for method development and detailed structural characterization of recombinant proteins to support the clinical and commercial biotechnology product portfolio.

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A Scientist position is available in Protein Analytical Chemistry (within US Biologics Pharma Technical Development, PTDU).  Responsibilities will include analytical characterization of recombinant proteins – primarily monoclonal antibodies and antibody-drug conjugates - using techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and capillary electrophoresis (CE).  This will include development, optimization, and validation of analytical methods to be used for characterization and/or quality control of therapeutic protein candidates.  The individual will provide analytical support to different functional groups in PTDU and actively participate in project teams consisting of members from all areas of process development. The individual may be responsible for managing 1-2 research associates, depending on experience level....

Job Description:

A position is available for a Scientist / Senior Engineer (E4) in the Purification Development department. The successful candidate will support the development and implementation of recombinant protein purification processes from laboratory to manufacturing scale.  This will include process optimization and product characterization as well the support of high throughput experiments and lab automation activities within the Purification Development department.  Activities will include the development of homogenization, centrifugation, chromatography & filtration operations, analytical methods such as electrophoresis and HPLC and the design and execution of high throughput experiments using robotic systems.

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The Department of Safety Assessment at Genentech providesscientific leadership and plays an active role in the process of drugdevelopment from late-stage discovery through marketed products. We are seeking an Associate Scientist/Scientist in the Department of Safety Assessment to supportdrug discovery and development.   This role will involve working in acollaborative team environment as part of the comprehensive safety assessmentof Genentech therapeutics by providing discovery and investigative toxicologysupport to early stage small molecule research programs.  

Responsibilities

Proactive risk assessment ofpotential toxicity issues related to undesired or exaggerated pharmacology,investigation or characterization of potential toxicity issues to enable smallmolecule lead optimization and candidate nomination.

 

In this role, the toxicologist willprovide representation to discovery project teams, which will include safetytarget assessments, strategic planning and designing, implementing andsupervising  toxicology studies in support of compound lead optimization(e.g. in vitro toxicity screening, counter-assay development) and mechanisticinvestigations (development of hypothesis-driven research plans, in vitro or invivo model development and qualification, and scientific projectmanagement).  This position will include staff supervision as needed andcontributing to the continued refinement of lead optimization andinvestigational strategies and identification of new technologies.  Thediscovery toxicologist will interact closely with research scientists andSafety Assessment development toxicologists and pathologists to ensure thatdiscovery teams consider all of the appropriate strategic needs for candidateidentification with regard to toxicology issues, thus providing bettercandidate selection and characterization of toxicology issues at the time oftransition to early development.

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The Department of Safety Assessment at Genentech provides scientific leadership and plays an active role in the process of drug development from the discovery period through marketed products.

 

We are seeking a Scientist in the Department of Safety Assessment to support drug development. This role will involve working in a collaborative team environment as part of the comprehensive safety assessment of Genentech therapeutics by providing toxicology representation to small molecule programs.

 

Responsibilities:

The successful candidate for Scientist will provide scientific leadership and play an active role in the process of drug development from late-stage discovery through marketed products. Working in a collaborative team environment, the Scientist/toxicologist leads the safety assessment of Genentech therapeutics by creating a best-evidence synthesis of existing knowledge and comprehensive investigations of toxicologic activity. The successful candidate will design and supervise toxicology studies to support the goals of small molecule project teams, work closely with Study Monitors, Pathologists, Pharmacokineticists and Pharmaceutics to deliver high quality GLP and non-GLP in vivo study reports and, as needed, represent Genentech in meetings with regulatory authorities. Responsibilities include interdisciplinary project team membership, preparation and review of regulatory documentation, study reports and manuscripts, participation in toxicology and pharmacology initiatives, and other active cross-functional collaborations. Additional responsibilities include investigations into mechanisms of toxicity, proactive management of potential safety liabilities and communication of impact to teams and governance committees. Experience with cross-functional teams and capability to build productive cross-functional collaborations both within and external to Genentech are desired.

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We have an opening for a talented Scientist to join our Biochemical and Cellular Pharmacology Department. The successful candidate will be responsible for supporting mass spectrometric characterization of antibody therapeutics and antibody drug conjugates. More specifically, the individual will focus on developing, validating and executing various mass spectrometric assays to evaluate antibody therapeutics and antibody drug conjugates from both in vitro and in vivo studies to support lead-finding/optimization efforts in the context of multidisciplinary project teams. Working with automation and bio-informatics experts, the individual will be expected to implement robust and high throughput sample preparation as well as data analysis workflows for mass spectrometric assays. The candidate will have the opportunity to conduct detailed data analyses and will present these data to project teams and senior management. In addition, the candidate will function as part of a multi-disciplinary project team that will coordinate with protein science, chemistry, in vitro and in vivo groups to advance lead molecules of the projects....

The Clinical Pharmacology Department at Genentech, Inc. is seeking aPh.D. level scientist who is driven to understand the Clinical Pharmacokineticsand Pharmacodynamics of novel drug candidates in the area of Oncology. This individual will lead and support Clinical Pharmacology activities ofAntibody Drug Conjugates across all phases of clinical development.  Thisperson will have responsibility for the Clinical Pharmacology Strategy toensure that appropriate dose/route/schedule decisions are made using state ofthe art modeling and simulation strategies that are aligned with projectneeds.  This will be accomplishedby working in close partnership with Clinicians, Biostatisticians and projectteams Responsibilities will include planning and reviewing study designs,analysis plans, data analysis, interpretation of PK/PD as well as planning,implementation and organization of regulatory filings (worldwide) andpresentation of data at cross-functional teams, department meetings, conferencesand regulatory meetings (worldwide). Additionally this individual will also bedirectly involved in leading project sub-teams and representing the function atcross-functional project teams....

The Preclinical and Translational PK/PD Department at Genentech,Inc. is seeking a Ph.D. level scientist who is driven to understand the pharmacokineticsand pharmacodynamics of novel drug candidates with a focus on proteintherapeutics including antibody drug conjugates. This individual will beresponsible for investigating the pharmacokinetics, biodistribution, and PKPDrelationships of novel therapeutics in preclinical models to identify leadcandidates for further development, and for all relevant translational aspectsbridging preclinical PKPD information to patients. This individual will beresponsible for the PK and PKPD strategy to support preclinical development andfirst in human regulatory filings, including planning, designing, analyzing, interpretingand reporting PK and PKPD studies. This will be accomplished by working inclose partnerships across various functions including Research, DevelopmentSciences, Clinical Sciences, Biostatistics, and Regulatory. This individualwill represent the department on cross functional project teams as the PKPDrepresentative and/or pharmacology sub-team leader. An additional componentwill be the presentation of PK/PD results at cross-functional teams, departmentmeetings, review committees, conferences and regulatory meetings.

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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 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 cell signaling and cancer genomics, evidenced by peer reviewed publications in top tier journals, is required.  Practical experience with predictive or pharmacodynamic biomarker development in an industry setting would be an important asset.  The successful candidate is expected to effectively lead cross functional teams, to publish innovative biomarker or disease focused research in high quality scientific, technical or medical journals, present to our key investigators and at meetings and promote collaborative efforts to push biomarker sciences forward. Scientists / Sr. Scientists in OBD are expected to be, or develop into, externally recognized leaders in clinical translational sciences.

 

 

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

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

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The Discovery Oncology department is seeking an exceptional and highly motivated scientist to join a team focused on the discovery and validation of novel oncology drug targets and the discovery of biomarkers predictive of the clinical efficacy of novel cancer therapeutics. Current efforts of this team are largely directed to developing a mechanistic understanding of tumor cell sensitivity and resistance to molecularly-targeted anti-cancer agents. Aspects of cancer cell biology of particular interest include epigenetic regulation and intra-tumor heterogeneity.

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Who we are

At the RocheGroup, about 80,000 people across 150 countries are pushing back the frontiersof healthcare. Working together, we've become one of the world's leadingresearch-focused healthcare groups. A member of the Roche Group, Genentech hasbeen at the forefront of the biotechnology industry for more than 30 years, usinghuman genetic information to develop novel medicines for serious andlife-threatening diseases. The headquarters for Roche pharmaceutical operationsin the United States, Genentech has multiple therapies on the market for cancerand other serious illnesses. Please take this opportunity to learn aboutGenentech, where we believe that our employees are our most important asset andare dedicated to remaining a great place to work.

 

The Position

The successful candidate will participate in cross-functionalproject teams discovering antibodies with high therapeutic potential to addressmajor unmet medical needs across different therapeutic areas.  This hire will lead a group discoveringantibodies from immunized sources. Research by this group will included enhancing understanding andoptimizing the immune response in immunized mice plus isolation and culturingof antigen-specific B cells.  Thisindividual is expected to collaborate closely with colleagues in other antibodydiscovery groups and other departments.

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A position is available for a Scientist / Senior Engineer (E4) in the Purification Development department. The successful candidate will support the development and implementation of recombinant protein purification processes from laboratory to manufacturing scale.  This will include process optimization and product characterization as well the support of lab automation activities within the Purification Development department.  Activities will include the development of homogenization, centrifugation, chromatography & filtration operations, analytical methods such as electrophoresis and HPLC and the design and execution of high throughput experiments using robotic systems.
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Scientist/Senior Scientist (Pathologist) - Development Sciences, gRED, Genentech, Inc.

The Safety Assessment Department of Genentech within the Development Sciences organization is seeking a Senior Scientist or Scientist - Pathologist with demonstrated expertise in drug development. Safety Assessment Pathologists at Genentech provide scientific leadership and play an active role in in the process of drug development from research through marketed products.  Working in a team environment, Safety Assessment Pathologists participate in the design, implementation and data analysis of both GLP and non-GLP investigative studies to ensure the comprehensive, highly integrated safety profiling of Genentech drug candidates.

Responsibilities will include interdisciplinary project team participation and leadership, design and conduct of regulatory, investigative and mechanistic studies.  The position also requires functional area mentor-ship, peer review of regulatory studies, authorship on regulatory documents and representation of Genentech at meetings with regulatory authorities, as needed....

Scientist/Sr. Scientist (Department of Immunology)

 

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

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Provide accurate and effective administrative support Managers within the group, and coordinate administrative duties with other Administrative Associates to provide seamless support for the group. Identify and anticipate needs of the group and plan work activities accordingly. Look for areas of activity overlap with co-workers and leverage resources to maximize time, resources and dissemination of information. Manage multiple schedules with heavy calendaring of complex meetings. Arrange, coordinate and support meetings, events, and activities both on and off-site. Generate, disseminate and maintain documents and information. Develop, implement and evaluate department work processes and procedures. Manage deadlines related to business planning as well as other special projects. Collaborate with Admin team to support complex projects and deadlines General office responsibilities include but not limited to: Schedule and coordinate staff onsite/offsite meetings, create and prepare presentation materials, assist with special projects, schedule travel for staff, process payment and expense reports, maintain files, order department office supplies, maintain photocopying equipment, order catering and other supplies for a variety of meetings and events, greet visitors, disseminate information, fully utilize PC and software applications. Ensure compliance with policies Integrate and facilitate communication with individuals, the team, the department and other functions across the company Attend and actively participate at staff level meetings as required, coordinate/publish agenda and minutes from meetings Integrate and actively participate in administrative associate team meetings and projects as requested The ideal candidate will succeed not just by completing tasks, but by proactively working to maximize the effectiveness of the managers and otheradministrative\nassociates in the group. Provide judgment in sensitive, confidential and complex information. Flexibility to take direction on projects from team and co-workers and work projects yet demonstrate autonomy in managing time and priorities. Proactive problem solving and decision-making within agreed parameters. Customer service orientation. Demonstrated successful experience indicating attention to detail, ability to work independently and in teams, strong follow up skills and ability to manage multiple projects simultaneously. Individual must possess strong, positive interpersonal skills and have the ability to work with diverse individuals. Must be willing and able to handle large volume of routine work, as well as more challenging projects and provide a consistently accurate work product.

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