- Programmable Medicine Operatin (Redwood City, CA)
- …an experienced individual to focus on leading our contract manufacturing efforts including Drug Substance and Drug Product. The successful candidate will ... a pharmaceutical or biotechnology company Key Responsibilities Act as drug substance and drug product...technical documents such as protocols, reports, risk assessments, and CMC sections of regulatory filings Ability to review master… more
- 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 (Boston, MA)
- … CMC leadership to both commercial and development projects with a focus on biologics drug substance . This role serves as a central leader within ... the Biologics Development and Launch (BDL) group. Responsibilities: + Develop...+ Develop comprehensive project plans, budgets, timelines and strategy; biologics projects at all stages of development are included,… 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
- Sanofi Group (Framingham, MA)
- …characterization testing, and quality/regulatory documentation. Includes raw materials, in-process materials, drug substance , and drug product. **About You** ... **Job Title:** Global Head, BioAnalytics, CMC Development **Location** : Framingham, MA **About the...of medicine? The race is on to speed up drug discovery and development to find answers for patients… 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
- 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
- Merck (Rahway, NJ)
- …as a Biologics Cell Culture Leader!** The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is ... & commercialization to spearhead our ever growing and dynamic late stage biologics pipeline within the expansive Biologics S&T portfolio. **Why You'll… 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
- Catalent Pharma Solutions (Kansas City, MO)
- …services for stand-alone and integrated biologics projects. We provide support for drug substance , drug product, and intermediates for both innovator and ... City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical...Matter Expert, as required + Responsible for the controlled substance programs at KCM to include holding Power of… more
- Merck (Rahway, NJ)
- …our company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our company's biologics pipeline. We work ... with both internal and external partners including vendors + Knowledge of biologics CMC development cycle + Demonstrated ability for taking initiative,… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …team is responsible for development and transfer of safe, efficient, and approvable biologics drug substance manufacturing processes and analytical methods ... for all of BMS' biologics portfolio. We work closely with other BMS units...production including complex Fusion proteins, Bi-specific antibodies and Antibody Drug Conjugates. + Using sound scientific and engineering methodologies… 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
- Bristol Myers Squibb (Devens, MA)
- …managing and influencing external partnerships (CDMOs/CMOs) to achieve strategic outcomes. + Knowledge of CMC regulatory, drug substance & drug product ... This role is responsible for developing and executing the CMC strategy for assigned products, managing key technical risks,...years (MS), or 12+ years (Ph.D.) of experience in biologics or cell therapy process development, tech transfer, or… more
