• Principia Biopharma (South San Francisco, CA)
    …potencies and selectivities that have the potential to rival those of injectable biologics , yet maintain the convenience of a pill. PRN1008, a reversible covalent ... Phase 1 trial in patients with solid tumors. Job Description:Reporting to the Director of Supply Chain, this individual will be accountable for the commercial supply… more
    Principia Biopharma (03/25/19)
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  • NGM Biopharmaceuticals (South San Francisco, CA)
    …growth. Hands on experience with regulatory strategy both early and late stage biologics . Direct point of contact with FDA on projects. Ability to participate in ... in diabetes, liver diseases, ophthalmic and oncology.The Senior Manager/Associate Director will develop and implement global regulatory strategies encompassing… more
    NGM Biopharmaceuticals (03/25/19)
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  • AbbVie (South San Francisco, CA)
    …of DMPK, PBPK/PKPD modeling and human dose prediction of small molecules and biologics , and able to give clear recommendations for the design of preclinical and ... clinical studies. Hands-on experience in modeling software like Phoenix, WinNonlin, Matlab/SimBiology etc. is required. Must have strong communication skills and the ability to influence, negotiate and communicate with both internal and external stakeholders.… more
    AbbVie (03/25/19)
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  • Five Prime Therapeutics (South San Francisco, CA)
    …phases that have the potential to yield our next wave of development-stage therapeutic biologics . And we continue to fuel this process at the earliest stages with ... This is a key quality management role reporting to the Senior Director of Quality Assurance.Responsibilities include:Partner with IT Compliance to provide quality… more
    Five Prime Therapeutics (03/25/19)
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  • Five Prime Therapeutics (South San Francisco, CA)
    …phases that have the potential to yield our next wave of development-stage therapeutic biologics . And we continue to fuel this process at the earliest stages with ... report into the Clinical Program Manager (CPM) or Associate Director / Director (AD/D) of Clinical Operations.Key accountabilities:Manage cross-functional Study… more
    Five Prime Therapeutics (03/25/19)
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  • Five Prime Therapeutics (South San Francisco, CA)
    …phases that have the potential to yield our next wave of development-stage therapeutic biologics . And we continue to fuel this process at the earliest stages with ... our products. Discover more about FivePrime at .Job DescriptionReporting to Senior Director of Quality, we are seeking a highly motivated and ambitious individual… more
    Five Prime Therapeutics (03/25/19)
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  • Rigel Pharmaceuticals (South San Francisco, CA)
    …Affairs, receive guidance from and collaborate extensively with the Medical Director of Medical Affairs and support US-based medical and scientific ... 5+ years of MSL experience strongly preferred.Previous experience in recently-launched biologics or therapeutics is a plus.Preference will be given to candidates… more
    Rigel Pharmaceuticals (03/25/19)
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  • Nektar Therapeutics (San Francisco, CA)
    …early to late-stage drug product formulation development within Nektar's biologics portfolio.Leads drug product development programs responsible for advancing the ... configurations. Knowledge of protein and peptide stabilizing strategies. Understanding of biologics bulk drug substance development aspects pertinent to drug product… more
    Nektar Therapeutics (03/25/19)
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  • Nektar Therapeutics (San Francisco, CA)
    Position OverviewThe Associate Director , Biologics is responsible for directing and developing the team responsible for bioassay method development and ... testing.As part of Nektar's Biologics CMC organization, the Associate Director , Biologics will support Nektar drug candidates in pre-clinical and clinical… more
    Nektar Therapeutics (03/25/19)
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  • Exelixis (Alameda, CA)
    …commercial and clinical supply chain, for our established small molecules and upcoming biologics programs. The Executive Director , Supply Chain will report to ... the Vice President of Pharm Ops, Manufacturing and Supply Chain. This individual will provide leadership, management, and vision to ensure that the company effectively and efficiently delivers exceptional supply chain outcomes for our growing global business… more
    Exelixis (03/21/19)
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  • Nektar Therapeutics (San Francisco, CA)
    …metabolism and elimination) properties of NCE (new chemical entities) and biologics to prioritize them for further multidimensional optimization. Has a track ... significant success in multidimesional optimization of NCE's. Must have experience with biologics . Experienced with IND enabling studies. Applies state of the art… more
    Nektar Therapeutics (03/25/19)
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  • Coherus BioSciences (Redwood City, CA)
    You will: We seek a Director /Sr. Director with strong strategic and hands-on experience in preclinical PK, pharmacology and toxicology of biologics , with ... deep knowledge of the mechanisms of action of biologics and in vitro and in vivo characterization of molecule's function, pharmacology and safety, and with a strong… more
    Coherus BioSciences (03/12/19)
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  • MEIRxRS / Med Exec Intl (Menlo Park, CA)
    …(internal/external) clinical operations staff.Industry experience within pharmaceutical and/or biologics and prior experience in FDA negotiations relating to ... the conduct of regulated clinical trials.Comprehensive understanding of applicable clinical research regulations. Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.Day to Day Responsibilities Oversee the… more
    Top Echelon (02/16/19)
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  • Jazz Pharma (Palo Alto, CA)
    …biomarkers of efficacy and mechanism of action of small molecule drugs and biologics . * Excellent communication skill with ability to function within ED and in ... matrixed, cross functional teams. * Ability to independently design experiments, and analyze experimental data and present results in both non-clinical and cross-functional team settings. * Collaborate with CROs to outsource studies, design via protocols,… more
    LinkUp (03/25/19)
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  • 4D Molecular Therapeutics (Emeryville, CA)
    …unlocking the full potential of gene therapy.We seek an experienced Associate Director / Director , Regulatory Affairs, CMC to oversee regulatory CMC activities and ... biological drug submissions (eg, IND, BLA, MAA), is preferred.Experience with biologics required, with experience in cell/gene therapy drug development highly… more
    4D Molecular Therapeutics (03/25/19)
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  • Bristol-Myers Squibb Company (Redwood City, CA)
    …to make a significant impact within a department that is driving the biologics pipeline within BMS. The successful candidate is expected to evaluate novel antigen ... is desirable.Highly innovative and self-motivated.Excellent time management and organizational skills.Demonstrated ability to work in a multidisciplinary biologics discovery… more
    Bristol-Myers Squibb Company (03/25/19)
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  • Bristol-Myers Squibb Company (Redwood City, CA)
    …personal lives.We are seeking a skilled biochemist /molecular biologist/immunologist at the Assistant Director level to work on a variety of cutting edge projects at ... biology, protein expression, and purificationDemonstrated ability to work in a multidisciplinary biologics discovery teamExcellent written, oral, and organizational… more
    Bristol-Myers Squibb Company (03/25/19)
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  • Bristol-Myers Squibb Company (Redwood City, CA)
    …formulations is highly desirable. Excellent time management and organizational skills. Demonstrated ability to work in a multidisciplinary biologics discovery team. ... The candidate will be expected to lead a group of scientists to generate proteins (antigens and antibodies) using disparate modalities for therapeutic and reagent generation.Specific Responsibilities: Establish a high functioning protein production core group.… more
    Bristol-Myers Squibb Company (03/25/19)
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  • Commercial Director , Biologics

    Danaher Corporation (San Jose, CA)
    …organizations are working with IDBS to implement their digital platform for biologics development, transforming their operations and realising the full benefit of ... way in this sector, we are hiring a Commercial Director who will be responsible for developing and executing...who will be responsible for developing and executing our Biologics Go-To-Market (GTM) strategy. Reporting directly to the VP… more
    Danaher Corporation (03/15/19)
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  • Regulatory Program Director , Pharma…

    Genentech (South San Francisco, CA)
    Regulatory Program Director , Pharma Technical Regulatory South San Francisco California, United States of America Job ID: 201901-102645 Download PDF Apply For This ... OR. We are actively seeking talent for our Pharma Technical Regulatory, CMC, Biologics Development Group & Biologics Marketed Products Group. In the position… more
    Genentech (02/05/19)
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