- Organon & Co. (Jersey City, NJ)
- …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 (Rahway, NJ)
- …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 (Rahway, NJ)
- …Cell Based Sciences team in Rahway, NJ is seeking a motivated scientist with technical expertise in **Biologics Potency** assays in drug **Development** . ... context of broader process and product development. + Working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing … more
- Merck (Rahway, NJ)
- **Job Description** **Senior Principal Scientist , Precision Medicine, Immunology** Precision Medicine is an integral part of our Immunology Therapeutic Area. To ... aligned with the Precision Medicine goals for relevant programs/assets The Senior Principal Scientist is responsible for maintaining a strong scientific fund… more
- Merck (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions. Under the general scientific and administrative direction of ... next generation process development and characterization, process validation, and regulatory submission authoring **In this role, the successful candidate will… more
- Merck (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for… more
- ThermoFisher Scientific (New Brunswick, NJ)
- …biologic Drug Substance and Drug Products across internal and external manufacturing sites. The principal scientist reports to the Associate Director of GBS ... stability protocols, and preparation, review and approval of CMC elements of regulatory filings to support the activities of the Global Biologics Stability program… more
- Merck (Rahway, NJ)
- **Job Description** The Senior Director (Sr. Principal Scientist ) has primary responsibility for the planning and directing clinical research activities ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director May… more