- Insmed Incorporated (NJ)
- …in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics , and combination product programs from toxicology ... vendor management experience.Proven expertise in root cause analysis, investigations, change control , and Quality risk management.Direct experience with clinical… more
- Insmed Incorporated (NJ)
- …for development programs.What You'll Do: Accountable for reviewing and approving all CMC change control documents and disposition of proposed changes and ... of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs, CMC will be responsible for reviewing the CMC post approval changes,… more
- Parexel (Columbia, SC)
- …and post-approval changes Cross-Functional Collaboration - Partner with manufacturing, quality , and external organizations to address CMC -related issues ... highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's… more
- Merck & Co. (Rahway, NJ)
- …Machine Learning, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control , Manufacturing Scale-Up, Mentorship, Process ... Job Description Join Our Team as a Biologics Cell Culture Leader! The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Janssen. This effort will extend to participation in a variety of cross functional CMC and quality forums under the Joint Manufacturing Committee in the ... and commercial support. The Quality Compliance scope includes working on Quality related sub-teams such as change control sub-teams and investigational… more
- Endo International (Horsham, PA)
- …work to bring the best treatments forward. Our shared values of Integrity & Quality , Innovation, Drive, Collaboration and Empathy guide our team and enable us to ... with at least 5 years' experience in a leadership role; commercial biologics manufacturing experience preferred. + Proven ability to lead teams, drive change,… more
- Teva Pharmaceuticals (West Chester, PA)
- CMC Biologics Quality Control Director, Physichemical Testing Date: Oct 17, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... CMC organization Design, plan, organize, analyze, and evaluate key elements of Biologics CMC QC strategy Specialized Knowledge: LIMS, TrackWise or VEEVA … more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Recruit and hire new talent. + Accountable for: + Defining critical quality attributes (CQAs) across the late-phase biologics portfolio and building deep ... across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality , Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical… more
- Sanofi Group (Framingham, MA)
- …people's lives and delivering compelling growth. Our Global Chemical Manufacturing and Control ( CMC ) Development function within Global R&D covers multiple ... **Job Title:** Global Head, BioAnalytics, CMC Development **Location** : Framingham, MA **About the Job** Are you ready to shape the future of medicine? The race is… more
- Parexel (Providence, RI)
- …and post-approval changes Cross-Functional Collaboration * Partner with manufacturing, quality , and external organizations to address CMC -related issues ... highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …Regulatory Submission support for US FDA and other Health Authorities. + Ensures all Quality by Design (QbD) and Design Control activities related to drug ... support of company clinical trials. + Collaborates with other external functions on CMC matters (eg, Quality , Commercial, Regulatory Affairs, etc.). Ensures the … more
- Gilead Sciences, Inc. (Foster City, CA)
- …and hire new talent. + Defining excipient and process reagent testing and control strategy across the late-phase biologics portfolio and building deep ... across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality , Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical… more
- Boehringer Ingelheim (Duluth, GA)
- …alignment with corporate goals. + Defines, plans, and oversees the development of high- quality CMC regulatory submissions, with a focus on securing timely ... with Quality , R&D and Operations/Manufacturing. The Director, Scientific Expert CMC provides subject matter expertise in functional areas related to, and driven… more
- Genentech (Oceanside, CA)
- …related discipline. + 15+ years of experience in the bio-pharmaceutical industry, ie biologics manufacturing, development or related CMC functions, with at least ... **The Position** The PTD Global Biologics organization plays a pivotal role in the...DS/DP Process Equipment, Analytical Instrumentation for Process Monitoring and Control , AI applications, and Process Modeling. The role also… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** **Key Responsibilities** Senior Manager, Global External Manufacturing Biologics supports uninterrupted supply of Gilead's clinical and commercial ... Development and Manufacturing organization (PDM). Experience in leading the Manufacture of Biologics Drug Substance is a must. This role requires collaboration at… more
- AbbVie (North Chicago, IL)
- …through innovative solutions. We are responsible for all Chemistry, Manufacturing, and Control ( CMC ) analytical activities related to the development of AbbVie's ... specialized protein separation techniques to enable the analysis of product quality attributes of interest. + Troubleshoot equipment and experimental problems. +… more
- Merck (Rahway, NJ)
- …Machine Learning, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control , Manufacturing Scale-Up, Mentorship, Process ... **Job Description** **Join Our Team as a Biologics Cell Culture Leader!** The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …and partners to provide strategic and technical guidance on Chemistry, Manufacturing and Control ( CMC ) issues. You focus on products incorporating polio and ... portfolio of high-impact product development grants to achieve cost, quality , safety, and therapeutic effectiveness targets. + Assist in...in the areas outlined below. + Experience in implementing CMC solutions for a broad range of biologics… more
- Catalent Pharma Solutions (Kansas City, MO)
- … Quality Unit objectives and focused on ensuring specific focus upon best-in-class Quality Control related procedures; + Maintain an effective Quality ... (QMS) that aligns with regulatory requirements/expectations, with particular focus upon Analytical and Quality Control ; + Ensure the QMS is agile and flexible to… more
- Genentech (South San Francisco, CA)
- …Scientist position is available in Genentech's Analytical Development and Quality Control (ADQC) department for US Biologics in the Pharma Technical ... biologics pipeline. This function provides integrated analytical control strategies and systems that enable CMC ...multidisciplinary team of analytical, biological, and quality control scientists in support of the CMC … more
