- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Principal Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry, ... in accordance with global regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC… more
- Organon & Co. (Jersey City, NJ)
- …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
- Merck (Rahway, NJ)
- …bioprocessing to join Biologics Process Research & Development (BPR&D) as a Principal Scientist . BPR&D within Research Laboratories is on a mission ... publish and engage with the scientific community to influence the field. As a Principal Scientist you will have the opportunity to influence the future direction… more
- Merck (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist . BPR&D within Research Laboratories is committed to rapidly ... engage with the scientific community to influence the field. As a Senior Principal Scientist , you will drive various strategic initiatives and translate… more
- Merck (Rahway, NJ)
- …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