- Organon & Co. (Plymouth Meeting, PA)
- …Principal Scientist will lead the preparation and submission of CMC dossiers for programs in clinical development, marketing applications and post-approval life ... **Job Description** **The Position** The Associate Principal Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry,… more
- Organon & Co. (Plymouth Meeting, PA)
- …for assigned biosimilar projects, with a specific focus on Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role includes oversight of ... development due diligence activities. **Responsibilities** + Provide global strategic regulatory CMC overview for respective products and portfolio. + Serve as the… more
- J&J Family of Companies (Malvern, PA)
- …**We are searching for the best talent for a** **Senior Principal Scientist (Modeling), BioTherapeutics Process Development** **to be onsite in Malvern, PA.** ... API Upstream Process Development team as a Senior Principal Scientist . You will lead development and implementation of computational...and cell culture media. You will be part of CMC team(s) and play a significant role in successful… more
- Teva Pharmaceuticals (West Chester, PA)
- Sr Scientist Date: Aug 30, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 63185 **Who we are** Together, we're ... Our multidisciplinary team advances biologics and biosimilars. Within Teva, Biologics CMC oversees biologic product development from IND submission through BLA… more
- Merck (West Point, PA)
- …products and combination products. We are seeking an experienced Associate Principal Scientist to advance and commercialize biologics pipeline program. As a member ... of the biologics drug product team, the Associate Principal Scientist will have a key focus on driving excellence...demonstration and qualification (PPQ) and shelf-life strategies. + Influences CMC regulatory strategy and is accountable for DP … more
- Parexel (PA)
- We are looking to fill a ** Scientist 2 or 3 - Analytical Chemist Metrology Specialist** position working as a full-time employee of Parexel FSP on long-term ... **Qualifications -** BS/MS in Chemistry, Biochemistry, Engineering, or a related discipline + ** Scientist 2** - BS with 1-2 years of relevant experience or MS with… more
- Parexel (PA)
- We are looking to fill a Bioanalytical Scientist position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients ... Immunology, Cell Biology, Biology, Biochemistry, Biology, or related biological science discipline** + Scientist 2: BS/BA 1-2 years of experience + Scientist 3:… more
- Parexel (PA)
- **Description** We are looking to fill a Scientist III - Regulated Immunogenicity and Molecular Bioanalytics (Vaccines) position working as a full-time employee of ... through meetings and in reports. + Provide input as a collaborating scientist on method development reports and test method optimization, qualification and… more
- Merck (West Point, PA)
- …comparability reports, Process performance qualification, and/or regulatory submissions. + ** CMC RA** : Experience supporting/writing regulatory filings (IND, MAA, ... multiple agencies (FDA, EMA, JNDA, TGA). + **Leadership:** Establish, manage and support CMC teams, and align resources to deliver on priorities. Manage and mentor a… more
- Parexel (PA)
- We are looking to fill a ** Scientist 3 - Analytical Chemist - Drug Product** position working as **a full-time employee of Parexel FSP on long-term assignment** ... + Analysis of drug products **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified… more