- Organon & Co. (Jersey City, NJ)
- …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. (Jersey City, NJ)
- **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. (Jersey City, NJ)
- …+ 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
- Merck (Rahway, NJ)
- …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
- Merck (Rahway, NJ)
- …with multiple agencies (FDA, EMA, JNDA, TGA). + **Leadership:** Establish, manage and support CMC teams, and align resources to deliver on priorities. Manage ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + ** CMC RA** : Experience supporting/writing… more
- Merck (Rahway, NJ)
- …Join our Company's Process & Product Modeling Team as an Associate Principal Scientist , where you will lead the development of advanced computational models that ... multidisciplinary scientists and engineers to create end-to-end predictive models that support drug substance and drug product manufacturing operations. + Develop… more
- Merck (Rahway, NJ)
- …in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products. The incumbent must be able to ... validation, and design control and risk management techniques to positively support and influence clinical and commercial combination product development and… more
- Merck (Rahway, NJ)
- …oversee analytical investigations with a strong focus on quality and regulatory compliance. + Excel in impurity isolation, unknown peak identification, ... leadership and collaboration. + Maintain a deep understanding of the regional regulatory and business environment, including: + API and Drug Product development… more
- Sanofi Group (Morristown, NJ)
- …toward all GPT members, including eg project management, clinical operations, regulatory , safety, translational medicine, statistics, CMC , IA **Basic ... team in achieving corporate goals. The GPH establishes the goals and will support staff within the program and participates in strategic planning for, and oversight… more