- Organon & Co. (Plymouth Meeting, PA)
- **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. (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
- Merck (West Point, PA)
- …products and combination products. We are seeking an experienced Associate Principal Scientist to advance and commercialize biologics pipeline program. ... member of the biologics drug product team, the Associate Principal Scientist will have a key focus...demonstration and qualification (PPQ) and shelf-life strategies. + Influences CMC regulatory strategy and is accountable for DP … 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
- Merck (West Point, PA)
- …experience working with CMOs and CROs. + Have a working knowledge of CMC filing requirements. + Demonstrate strong verbal as well as written communication skills ... attendance is required for, field-based positions; facility-based, manufacturing-based, or research -based positions where the work to be performed is located… more
- Merck (West Point, PA)
- …stages of cell culture process commercialization. + Experience in leadership of CMC development teams. + Experience authoring technical documentation in support of ... attendance is required for, field-based positions; facility-based, manufacturing-based, or research -based positions where the work to be performed is located… more