- Merck & Co. (South San Francisco, CA)
- …and analytical development , formulation, identification of process impurities, drug substance and product degradants, and characterization of other ... talented and dedicated colleagues while developing your career.The Analytical Research and Development organization in South San Francisco, CA is seeking a motivated… more
- AbbVie (South San Francisco, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Biologics Drug Product Development Internship Overview ... in the pharmaceutical industry. This is a reality for AbbVie Interns. The Biologics Drug Product Development department is within the AbbVie Bay… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Design and execute formulation and drug product process development work packages for biologics , to support pivotal formulation development , ... possible, together. **Job Description** The **Senior Research Scientist I, Biologics Pivotal Formulation and Process Development ** role...key functional strategies, and serve as drug product leads on PDM (Pharmaceutical Development &… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** **Senior Director, Biologics Drug Product MSAT** Gilead Sciences, Inc. is a ... network. We are accountable for direct technical support of drug substance and drug product ...regulatory factors, and cost of goods. Leads teams through drug development and manufacturing with an ability… more
- Gilead Sciences, Inc. (Foster City, CA)
- …monitoring QC test method execution and analytical lifecycle management of commercial biologics drug substances and drug products. **Responsibilities:** The ... and implementation of end-to-end Quality Control strategy for Gilead's portfolio of biologics products. + Contribute to staff development , budgeting and cost… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Senior Research Scientist I, Purification Development - Pre-Pivotal Biologics - Foster City, CA** At ... and process implementation at internal or external GMP facilities for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I/II).… more
- Gilead Sciences, Inc. (Foster City, CA)
- …, as an **Associate Scientist** . The successful candidate will contribute to the development of formulation and drug product processes for innovative ... drug process development , including molecular assessment, First-in-Human formulation development , Drug Product manufacturing process development ,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Qualifications:** + A scientific degree with directly relevant professional experience in biologics development , global CMC regulatory affairs, and CMC technical ... team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our...unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of… more
- Gilead Sciences, Inc. (Foster City, CA)
- … and Manufacturing organization (PDM). Experience in leading the Manufacture of Biologics Drug Substance is a must. This role requires collaboration ... at the Team Leadership level with the Development , Quality, Regulatory, Analytical, Supply Chain, and ...and routine supply **Qualifications** + Experienced in sterile large-molecule drug substance or large-molecule drug product… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to coordinate multi-functional activities relating to clinical and commercial drug product manufacturing processes, tech transfer, validation, supply/supply ... product compliance with regional regulatory requirements. + Partnering with product development , manufacturing, quality and regulatory, support quality… more
- Abbott (Alameda, CA)
- …metrics/information. **What You'll Work On** + Develop global regulatory strategies for product development and planning throughout the product lifecycle. ... implement and manage appropriate SOPs and systems to track and manage product -associated events. + Actively contribute to the development and functioning… more
- Amazon (Sunnyvale, CA)
- …Key job responsibilities * Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations ... project management skills as evidenced by past performance on drug development project teams About the team...leadership - . Regulatory Affairs Certification (RAPS) - . Drug and Biologics regulatory filing experience Amazon… more
- Gilead Sciences, Inc. (Foster City, CA)
- …preferred. + Broad experience across areas like CMO QA, Validation, Drug development experience and/or Pharmacovigilance and understanding of Parenteral, ... member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we… more
- AbbVie (South San Francisco, CA)
- …will have unique exposure to a significant breadth and depth of drug development experience, numerous cross-functional interactions, and opportunities to grow ... coordinate the GMP release and stability potency testing of biologics for early development programs. This role...bioassay scientists for the release and stability testing of drug substance and drug product … more
- Allogene (Newark, CA)
- …and solution preparation; CAR-T cell drug substance preparation; and CAR-T drug product fill operations * Accurate and timely completion of documentation ... viability and sterility of cell therapy products from PBMC thaw to final formulated drug product cryopreservation * Perform tasks in a manner consistent with… more
- Merck (South San Francisco, CA)
- …and analytical development , formulation, identification of process impurities, drug substance and product degradants, and characterization of other ... industry, establishing new NMR methods, and prospectively impacting problems related to drug discovery, characterization, and development + Strong knowledge of… more
- Boehringer Ingelheim (Fremont, CA)
- …operations in Downstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi- product facility. Performs duties under limited ... Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients...without restriction. + Must be willing to take a drug test and post-offer physical (if required) + Must… more
- Boehringer Ingelheim (Fremont, CA)
- …operations in Upstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi- product facility. Performs duties under limited ... Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients...practices, as well as a high technical knowledge of biologics principles required. + Working in a highly regulated… more
- BeiGene (San Mateo, CA)
- …with both small molecules and biologics . + Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment ... regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory...environment and assesses impact of changes on business and product development programs. Facilitates policy and … more
