- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as a Biologics Drug Substance & Cell Banking Leader!Are you ready to take your career to the next level? We are seeking a ... dynamic and visionary- Biologics Drug Substance & Cell...strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA: Experience supporting/writing regulatory filings (IND, MAA, BLA)… more
- Merck & Co. (Rahway, NJ)
- …Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP). ... Job DescriptionScientist (R2) Biologics Analytical North American GMP Operations, Rahway, NJ - We invite individuals who possess a deep passion for promoting… more
- Merck & Co. (Rahway, NJ)
- …Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP) ... individual to join our Rahway, NJ team as a Scientist (R2) in Biologics Analytical Research & Development (AR&D) GMP Operations, to support ELISA and cell-based… 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
- 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 (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
- 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)
- …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)
- …to take your career to the next level? We are seeking a dynamic and visionary Biologics Drug Substance & Cell Banking Leader to spearhead our cutting-edge ... within the expansive Biologics S&T portfolio. Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the… 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...matter experts to orchestrate and execute, within the network, CMC potency and impurity strategy and structure-function understanding of… 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
