- Organon & Co. (Jersey City, NJ)
- …regulatory strategies. + Prepare and review information required for development of regulatory CMC dossiers for commercial products. + Provide input to global ... milestones for assigned products across the product lifecycle. Identify and communicate potential regulatory issues to Organon Regulatory CMC management, as… more
- Amgen (Cambridge, MA)
- …patients worldwide. It's time for a career you can be proud of. Process Development Senior Principal Scientist - CMC Team Lead **Live** **What you will ... analytical sciences space. + Author chemistry, manufacturing and controls ( CMC ) sections in regulatory files, lead the...all use our unique contributions to serve patients. The Senior Principal Scientist professional we seek is… more
- Sanofi Group (Framingham, MA)
- …their families. The CMC -Biologics Statistics team is seeking an expert data scientist / Statistician to support the CMC activities for process, analytical ... to process development activities. + Broad knowledge of (bio)pharmaceutical development and CMC activities in a regulatory context, including good understanding… more
- Bristol Myers Squibb (Summit, NJ)
- …for drug product related CMC strategy development. **Key Responsibilities** The Senior Principal Scientist will collaborate across BMS sites with Analytical, ... questions from regulatory authorities. **Key Responsibilities** The Senior Principal Scientist will collaborate across BMS...and process development principles. + Experienced in building the CMC dossier for regulatory submissions as an… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …author/reviewer. + Principal Scientist incumbent is experienced in building the CMC dossier for regulatory submissions within the development section as an ... are uncommon in scale and scope. **Position Summary** Bristol Myers Squibb is seeking a Senior Scientist or Principal Scientist to join the Oral Product… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- J&J Family of Companies (Malvern, PA)
- Senior Scientist , Early Development Analytical Scientific Integrator - 2306147399W **Description** Janssen Research & Development, LLC, a division of Johnson & ... Johnson's Family of Companies, is recruiting for a Senior Scientist , Early Development Analytical Scientific Integrator (1 of 2). The position is located in… more
- J&J Family of Companies (Malvern, PA)
- Senior Associate Scientist , Cell & Gene Therapy, Materials Sciences - 2406194091W **Description** Johnson & Johnson is recruiting for a ** Senior Associate ... related to raw materials for our growing advanced therapies' portfolio. As a Scientist , you will play a vital role in performing lab studies, qualifying raw… more
- AbbVie (Irvine, CA)
- …manufacturing of biological toxins products in AbbVie. We have an exciting opportunity for a Senior Scientist II position based in Irvine, CA. The scientist ... & Technology - Biologics organization supports manufacturing, process validation, regulatory submission, and continuous improvement for late-stage and commercial… more
- AbbVie (Irvine, CA)
- …of biological toxins products in AbbVie. We have an exciting opportunity for a Senior Scientist position based in Irvine, CA. The scientist will ... & Technology - Biologics organization supports manufacturing, process validation, regulatory submission, and continuous improvement for late-stage and commercial… more
- AbbVie (North Chicago, IL)
- …laboratory data, technical memos and reports. + Collaborate to ensure successful CMC interactions with regulatory authorities. + The position involves ... AbbVie's clinical candidates. We are seeking a Principal Research Scientist II to conduct process research and development of...candidate will serve as the chemistry representative on the CMC team for ADC development programs and as such… more
- AbbVie (Irvine, CA)
- …+ Author CMC analytical sections of BLA and other CMC regulatory packages, including analytical methods, specifications, analytical comparability, and ... of biological toxin products at AbbVie. We have an exciting opportunity for a Senior Separations Scientist position based in Irvine, CA. + Lead the development,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …guidance documents, and reports). + Author/review and/or coach team members to author CMC regulatory sections of IND/INDa. Contribute to regulatory ... aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Research Scientist II, Purification Development - Pre-Pivotal Biologics… more
- Takeda Pharmaceuticals (Boston, MA)
- …You will also prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and reports ... order to bring life-changing therapies to patients worldwide. Join Takeda as a Scientist - Analytical Development (AD) - Late Stage Development where you will… more
- Lundbeck (Bothell, WA)
- Senior Scientist , Potency Assays for Antibodies Requisition ID: 5273 Location: Bothell, Washington, US Do you want to join a team where the mission is ... Potency team as needed + Assist in the preparation of CMC regulatory submissions including authoring and/or review **REQUIRED EDUCATION, EXPERIENCE and SKILLS:**… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Senior Research Scientist I, Purification Process Development (Pivotal and ... and aptitude for creative problem solving. + Experience writing CMC sections of commercial regulatory filings (BLA, MAA) and post approval change filings is… more
- Novo Nordisk (Watertown, MA)
- …+ Identify key stake holders and work collaboratively with cross-functional CMC , commercial, quality, regulatory , project management, legal, sourcing, supply ... a valuable team player. + Experienced in writing, reviewing, and approving CMC sections of regulatory filings from early-stage development through commercial… more
- AbbVie (Irvine, CA)
- …Job Description The Neurotoxin Research Group at AbbVie seeks an accomplished scientist and leader. The Director/ Senior Principal Research Scientist ... productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from early-stage… more
- AbbVie (Irvine, CA)
- …Aesthetics on LinkedIn. The Neurotoxin Research Group at AbbVie seeks an accomplished scientist and leader. The Director/ Senior Principal Research Scientist ... productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from early-stage… more
- Merck (Rahway, NJ)
- …Research and Development (ARD) at our company's Research Laboratories is seeking a senior scientist to work onsite with extensive experience in validation & ... closely with other analytical groups in ARD , Global Quality and Regulatory Affairs- CMC to ensure that validated methods are appropriately transferred from our… more