- 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 radiopharmaceutical CMC development and manufacturing programs supporting various...+ Familiarity with Stage 1-3 process validation and pharmaceutical product lifecycle management. + Excellent interpersonal, verbal, and written… more
- Teva Pharmaceuticals (West Chester, PA)
- CMC Biologics Quality Control Director , Physichemical Testing Date: Nov 15, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... and manage departmental strategies for physiochemical testing with respect to product in-process, release and stability testing, raw materials testing, contract lab… more
- Organon & Co. (Plymouth Meeting, PA)
- …Primary responsibilities include, but are not limited to: **Responsibilities** + Serve as the CMC Product Lead for assigned products and be accountable for the ... **Job Description** **The Position ** Reporting to the Director in Organon Regulatory CMC , the...of all regulatory milestones for assigned products through the product lifecycle. + Lead development and execution… more
- Merck (North Wales, PA)
- …will be to lead project management efforts to support Chemistry Manufacturing & Controls ( CMC ) product development from First in Human to Transfer to ... Development and Commercialization Teams (DCTs) responsible for building and executing CMC development plans. Under the guidance of the CIPM Director… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …including sample collection, storage conditions, and analytical testing, to support product development and regulatory submissions. + Author and review ... **Associate Director , Small Molecule Analytical Development ** +...development and optimization for drug substance and drug product at CDMOs + Design and lead method validation… more
- Sumitomo Pharma (Harrisburg, PA)
- …FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical industry + Experience reviewing ... with a minimum of 4 years focused in regulatory affairs + Oncology product development experience preferred + Experience contributing to electronic regulatory… more
- Sumitomo Pharma (Harrisburg, PA)
- …and FDA and ICH regulations/guidance specific to clinical research and general product development in the pharmaceutical industry + Experience reviewing ... to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Senior Director , Early Development Team Lead** **Role Summary:** The Early Development Team (EDT) Lead is a critical role - working to deliver Otsuka's ... problems and deliver data-driven decisions. -Ensures that the EDT delivers to Full Development assets that meet robust Target Reimbursable Product Profiles that… more
- Organon & Co. (Plymouth Meeting, PA)
- …, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls ( CMC ), medical affairs and business development are critical to ... oversee non-clinical activities and safety assessments for Organon Research and Development (R&D) programs ranging from discovery through late-stage development .… more
- Organon & Co. (Plymouth Meeting, PA)
- …in written format. + Track record of effective functional representation on product development teams. + Excellent verbal and written communication skills. ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology… more