- Organon & Co. (Plymouth Meeting, PA)
- …assigned products across the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as ... project timelines. **Preferred Experience and Skills** A candidate with experience in Regulatory CMC in clinical development, initial marketing application and… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( ... portfolio of small molecule or biologic products. The Principal Scientist may also support project team goals...will directly support projects and/or coordinate with Regulatory CMC scientists in the Organon franchise… more
- Organon & Co. (Plymouth Meeting, PA)
- …+ Execute regulatory strategies by developing, authoring, and reviewing CMC submission components and documentation to support post-approval supplements, ... strategies for assigned biosimilar projects, with a specific focus on Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role includes… more
- J&J Family of Companies (Malvern, PA)
- …the identification and mitigation of CMC risks, the completion of required CMC regulatory documents and responses, creation and adherence to budget and ... are searching for the best talent for a Distinguished Scientist , CMC Team Leader, Proteins to be...development improvements across the TDS organization. They may also support or lead teams in implementing initiatives to deliver… more
- J&J Family of Companies (Malvern, PA)
- …the identification and mitigation of CMC risks, the completion of required CMC regulatory documents and responses, creation and adherence to budget and ... are searching for the best talent for a** **Distinguished Scientist , CMC Team Leader, Protein Conjugates** **to...development improvements across the TDS organization. They may also support or lead teams in implementing initiatives to deliver… more
- Teva Pharmaceuticals (West Chester, PA)
- …teams, with ability to build cross-departmental relationships * Knowledge of CMC requirements for regulatory submissions (INDs, BLAs) and experience ... Sr Scientist Date: Aug 1, 2025 Location: West Chester,...multidisciplinary team advances biologics and biosimilars. Within Teva, Biologics CMC oversees biologic product development from IND submission through… more
- Merck (West Point, PA)
- …and influences process demonstration and qualification (PPQ) and shelf-life strategies. + Influences CMC regulatory strategy and is accountable for DP CMC ... transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The… 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 ... + Develop and qualify cell-based or ligand-binding based bioanalytical assays to support high priority biological and vaccine programs. + Analyze samples using… more
- Merck (West Point, PA)
- …scale-up and validation support , preparation of Chemistry, Manufacturing, and Controls ( CMC ) documents for global regulatory submissions, and responses to ... and Supply (ACDS) is seeking applicants for a Senior Scientist position available at the Rahway, NJ and West...method development and validation + Familiarity with authoring relevant CMC sections of regulatory submissions Current Employees… more
- J&J Family of Companies (Spring House, PA)
- …responses to regulatory agencies) for assigned projects in order to support the start of clinical trials, continued clinical development, and ultimately ... Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Scientist , Nonclinical Safety Lead within Preclinical Sciences and Translational Safety (PSTS).… more
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