- Lilly (Philadelphia, PA)
- …and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory , manufacturing, and supply chain teams, to ensure ... budget, and resource allocation, and provide regular updates to senior management. + Lead other tasks / projects as...projects and programs. + Advanced understanding of cGMPs and CMC regulatory requirements + Ability to manage… more
- Organon & Co. (Lansdale, PA)
- …Description** **The Position** Reporting to the Executive Director in Organon's Regulatory Chemistry, Manufacturing and Controls ( CMC ) New Products, the ... for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Primary responsibilities include, but… more
- Merck (West Point, PA)
- …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure development of robust ... regulatory posture + Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC . Strong experience in safety and environmental… more
- CSL Behring (King Of Prussia, PA)
- …knowledge in drug research, development and manufacturing processes of pharmaceuticals ( CMC , non-clinical, clinical, and regulatory ).** **Expert level skillset ... to treat serious and often rare conditions. Could you be our next Associate Director , R&D Project Planning Capability Lead? This position is located in our King of… more
- J&J Family of Companies (Spring House, PA)
- …as applied to cell therapy. * Communicate proactively on progress and issues to senior management, to regulatory agencies as necessary, and at national and ... Associate Director , Cell Therapy Decisional Analytics - 2406185128W **Description**...cross-functional teams supporting pre-clinical and clinical programs, focused on CMC development. Primary responsibilities for this role include but… more