- Programmable Medicine Operatin (Redwood City, CA)
- …and Responsibilities - Essential Functions *Develop various analytical methods. *Test various drug substance / drug product samples. *Manage, set up, and ... *Experience with analytical method development and various tests for polymer- drug conjugates and/or biologics drug ...writing experience such as protocols, reports, SOPs, and preparing CMC sections of IND. *Knowledge of GLP & GMP… more
- AbbVie (South San Francisco, CA)
- …dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. The CMC Biologics Drug Substance organization is a team of ... solutions. They are responsible for all Chemistry, Manufacturing, and Control ( CMC ) cell line and bioprocess development activities for AbbVie's early-stage and… more
- AbbVie (South San Francisco, CA)
- …(https://www.tiktok.com/@abbvie) . Job Description Sr. Scientist I Cell/Molecular Biology The Development Sciences Biologics CMC Drug Substance Cell Line ... design principles to optimize RNA expression levels and assembly of multi-chain biologics . + Design experiments and perform genetic characterization of CHO cell… more
- AbbVie (South San Francisco, CA)
- …Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Biologics CMC Development team at AbbVie has a long and ... rich history of biologics development. Now located in a new state of...and 2) develop robust, phase-appropriate cell culture processes for drug substance GMP production to enable human… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product. + Proven track record in ... and highly motivated Director for our Structural Characterization team in Biologics Pivotal and Commercial Analytical Development. Broad experience in analytical… more
- AbbVie (South San Francisco, CA)
- …and deliver workflow automation solutions that directly support scientists in groups such as drug substance , drug product, and cell line development. + ... portfolio delivery. Qualifications + PhD in a scientific discipline (Analytical Development, Biologics , Process Development, or related CMC field) with 4+ years… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and other process related impurity method development and techniques commonly used for drug substance release testing and process characterization (eg ELISA). + ... Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product. + Proven track record in… more
- Genentech (Oceanside, CA)
- …with a strong emphasis on safety, compliance, reliability, and cost-effectiveness in drug substance , drug product and respective process analytical ... related discipline. + 15+ years of experience in the bio-pharmaceutical industry, ie biologics manufacturing, development or related CMC functions, with at least… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Pharmaceutical Development and Manufacturing organization (PDM). Experience in leading the Manufacture of Biologics Drug Substance is a must. This role ... product launch and routine supply **Qualifications** + Experienced in sterile large-molecule drug substance or large-molecule drug product manufacturing and… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …projects. + Troubleshoots basic analytical methods and instrument operation. + Performs drug substance , drug product intermediate and drug ... corporate HQ in Foster City, CA **Preferred Qualifications** + Industry experience in biologics CMC development + Experience working in a laboratory setting… more
- AbbVie (South San Francisco, CA)
- …organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. The Biologics Drug Substance organization is a world-class team of ... solutions, but are also responsible for all Chemistry, Manufacturing, and Control ( CMC ) cell line and bioprocess development activities related to the development of… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product. + Proven track record in ... help create possible, together. **Job Description** **Principal Scientist in Biologics Analytical Development (Pivotal and Commercial).** United States - California… more
- Gilead Sciences, Inc. (Foster City, CA)
- …requests, the Notified Body Option). + Provide oversight for changes to drug substance and drug product CMC details. + Accountable for PAI/PLI readiness ... Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC , and the wider PDM Quality organization.** **Job Functions:**...Quality representatives at CXO(s) and Gilead Sites. + Support drug substance and drug product… more
- Genentech (South San Francisco, CA)
- …innovative and effective drugs using cutting edge technologies for manufacturing process ( Drug Substance and Drug Product), clinical supply, formulation, ... packaging, and analytical development. Together with our partners, Global Biologics Bioprocess Development develops robust, efficient, and sustainable bioprocesses… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Familiarity with FDA/EMA guidance for preclinical and early clinical phases. + CMC awareness: Understanding of drug substance /product development and ... Team Leads to support a diverse portfolio of small molecule and biologics drug candidates across development and commercial stages. There will be three Senior… more
