- Insmed Incorporated (NJ)
- …and collaborations with scientists to resolve technical and regulatory issues in drug substance synthesis, management of impurities and degradation products, ... FDA, EU, ICH, PMDA guidelines, initiatives and regulations governing CMC drug product development.Ability to deal with...to read and collate scientific and medical literature.Experience in drug substance and drug product… more
- Merck & Co. (Rahway, NJ)
- …as a Biologics Cell Culture Leader! The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is ... development & commercialization to spearhead our ever growing and dynamic late stage biologics pipeline within the expansive Biologics S&T portfolio. - Why… more
- Merck & Co. (Rahway, NJ)
- …our company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our company's biologics pipeline. We work ... collaborate with both internal and external partners including vendorsKnowledge of biologics CMC development cycleDemonstrated ability for taking initiative,… more
- Lundbeck (Bothell, WA)
- …of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us ... Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization....Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019,… 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
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