- Organon & Co. (Plymouth Meeting, PA)
- …project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on ... Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role...development due diligence activities. **Responsibilities** + Provide global strategic regulatory CMC overview for respective products and portfolio. +… more
- Merck (West Point, PA)
- …and pharmaceutical products and combination products. We are seeking an experienced Associate Principal Scientist to advance and commercialize biologics ... to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The...a member of the biologics drug product team, the Associate Principal Scientist will have… more
- Merck (West Point, PA)
- …within Analytical Chemistry in Development and Supply (ACDS) is seeking applicants for an Associate Principal Scientist position available at the West Point, ... to drive late-stage pharmaceutical drug product development and commercialization. The Associate Principal Scientist responsibilities include, but not… more
- Merck (West Point, PA)
- **Job Description** **Position Description:** The Associate Principal Scientist position will support our Live Virus Vaccines franchises. This broad role ... supply chain, site and global Quality, as well as CMC- Regulatory . This role will be based in West Point,...+ Writing or review of technical documents, preferably including regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections… more
- Merck (West Point, PA)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. Under the general scientific and administrative direction ... next generation process development and characterization, process validation, and regulatory submission authoring. **Responsibilities** : + Coordinate project planning,… more
- Merck (West Point, PA)
- …process enhancements, next generation process development, and authoring of regulatory submissions. Under the general scientific and administrative department ... functional area on cross-functional and cross-divisional teams. + Authors required regulatory and technical documentation. Ensures that processes are developed and… more
- Burns & McDonnell (Conshohocken, PA)
- **Description** Burns & McDonnell is seeking an Associate / Principal Engineer, Hydrogeologist, Scientist in a related field to join our successful team of ... capping, and other industry standard methods. + Strong working knowledge of regulatory frameworks, including CERCLA, RCRA, Section 401 and Section 404 permitting. +… more