- J&J Family of Companies (Horsham, PA)
- …be located in Horsham, PA; Spring House, PA; Titusville, NJ; or Raritan, NJ. The Director , CMC Regulatory Affairs Biologics New Modalities will lead a team ... Medicine R&D is recruiting for a Director , CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Biologics New Modalities. This position is a hybrid… more
- Lilly (Philadelphia, PA)
- …and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the execution of multiple ... Process Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority… more
- Organon & Co. (Plymouth Meeting, PA)
- …Scientist (Associate Director ) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned ... the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC...and escalate potential regulatory issues to Organon Regulatory CMC management, as needed **Required Education,… more
- J&J Family of Companies (Malvern, PA)
- …single submission. **We are searching for the best talent for an Associate Director , CAR-T Analytical Scientific Integrator - Advanced Therapies to be located in ... Malvern, PA or Leiden, Netherlands.** **Purpose:** The Associate Director , CAR-T Analytical Scientific Integrator will provide analytical, technical and strategic… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Merck (West Point, PA)
- …+ Collaborate with Research Laboratories, Process Development, Commercialization, Operations, Quality, Regulatory - CMC , and Supply Chain teams to ensure seamless ... Global Science and Technology (GSEC) organization is seeking a highly motivated Director to lead our Pneumococcal Franchises (PCV) - Development and Commercial Team… more
- Merck (West Point, PA)
- …control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + ** CMC RA** : Experience supporting/writing ... oversight of DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful… more
- Merck (West Point, PA)
- …BLAs.- The successful candidate will be responsible for strategic partnering with CMC development, Regulatory , Quality, and our partners in commercialization and ... and ensure safety and quality of our products. The Director of Vaccines Potency in Analytical Research & Development...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Teva Pharmaceuticals (West Chester, PA)
- …biosimilars, small molecule specialty medicines, generics and over-the-counter therapies. The Associate Director at Bioassay Department of Biologics CMC leads a ... Associate Director , Binding and Cell-Based Bioassay - Onsite (West...role requires close collaboration with cross-functional teams to support regulatory submissions. This role reports to the head (Senior… more
- CSL Behring (King Of Prussia, PA)
- …knowledge in drug research, development and manufacturing processes of pharmaceuticals ( CMC , non-clinical, clinical, and regulatory ). **BENEFITS** + Medical, ... used to treat serious and often rare conditions Could you be our next Senior Director , TA Portfolio Delivery Lead? The job is located in the King of Prussia, PA,… more