- Parexel (Harrisburg, PA)
- …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 (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 (Harrisburg, PA)
- …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
- J&J Family of Companies (Spring House, PA)
- …Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control ( CMC ), Coaching, Collaborating, Conducting Experiments, Data Quality , Drug ... Johnson & Johnson Innovative Medicine R&D is recruiting for a Scientist, Biologics located in Spring House, PA. We are seeking a Scientist, … more
- Merck (West Point, PA)
- **Job Description** **Principal Scientist, Biologics , Sterile Drug Product Commercialization** As part of Our Company's Manufacturing Division, the Sterile Drug ... capabilities for late stage and commercial drug product processes for vaccines, biologics , and sterile pharmaceutical products. It is the division's leader in… more
- J&J Family of Companies (Malvern, PA)
- …delivery approaches. + Clinically Relevant Controls: + Establish science and risk-based control strategies that link quality attributes to potential impact on ... **Preferred Skills:** Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control ( CMC ), Clinical Research and Regulations, Clinical… more
- Sanofi Group (Swiftwater, PA)
- …support, lifecycle management, and process optimization-all focused on delivering high- quality products to patients worldwide. Join our dynamic global network ... recombinant proteins, manufacturing support, Phase 3 clinical material production, CMC strategy development, and new product introductions. Your leadership will… 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
- J&J Family of Companies (Malvern, PA)
- …areas. + Partner closely with formulation, primary container development, human factors, quality , regulatory, and CMC teams to ensure integrated drug-device ... product manufacturing to clinical and commercial sites. + Support device product quality investigations, CAPAs, and change control activities. + Communicate… more
- J&J Family of Companies (Spring House, PA)
- …Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control ( CMC ), Coaching, Collaborating, Conducting Experiments, Data Quality , Drug ... Medicines (CGM) organization is dedicated to developing, testing, and producing high- quality new molecular entities (NMEs) through innovative cell and genetic… more
