- Parexel (Trenton, NJ)
- …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
- 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
- Merck (West Point, PA)
- …(DCT) leader is accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... product. The specific role will be responsible for advancing the company's biologics portfolio. Correspondingly, the DCT leader will be responsible for delivering… more
- Parexel (Trenton, NJ)
- …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 (Wilmington, DE)
- …products to its global network. Wilmington Biotech Campus - Analytical Development and Quality Control Laboratory The Analytical Development and Quality ... Large Molecule Analytical Science (GQMAS), the Site Analytical Development and Quality Control Lead is accountable for establishing a transformational approach… more
- Merck (West Point, PA)
- …capabilities for late stage and commercial drug product processes for vaccines, biologics , and sterile pharmaceutical products. The SDPC team is based out of ... for today's innovative and accelerated commercialization of novel vaccines, biologics , pharmaceutical products and combination products. The SDPC group supports… more
- Actalent (Philadelphia, PA)
- …studies. + Significant experience in drug manufacturing or biologics industry in Quality Assurance, Quality Control , or Quality Engineering position. ... including deviations, OOS results, and non-conformances. + Collaborate with CDMOs and internal CMC teams to ensure quality standards are met from development… more
- J&J Family of Companies (Malvern, PA)
- …Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control ( CMC ), Coaching, Collaborating, Conducting Experiments, Data Quality , Drug ... discussions, resolving issues with equipment suppliers, project teams, and quality partners. + Designing and deploying automation solutions across manufacturing… more
- Mallinckrodt Pharmaceuticals (Horsham, PA)
- …with at least 5 years' experience in a leadership role; commercial biologics manufacturing experience preferred.Proven ability to lead teams, drive change, and lead ... and direct experience with site regulatory inspections.KnowledgeStrong knowledge of biologics manufacturing technologies & processes including upstream and downstream… more
- Merck (West Point, PA)
- …code conventions; suggest incremental improvements. + Collaborate with Finance, Supply Chain, Technology, Quality , CMC , and VCM teams to gather inputs and share ... our VCM teams across the Small Molecule, Vaccines, and Biologics operating units. This is an exciting opportunity to...(LROP) and supply planning. + Basic familiarity with version control technologies such as Git and Github. + Introductory… more
