- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) ... for the assigned portfolio of small molecule or biologic products. The Principal Scientist may also support project team goals and organizational initiatives, on an… more
- Organon & Co. (Jersey City, NJ)
- …Principal Scientist will lead the preparation and submission of CMC dossiers for programs in clinical development, marketing applications and post-approval life ... **Job Description** **The Position** The Associate Principal Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry,… 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
- Atlantic Health System (Pompton Plains, NJ)
- …+ High school diploma or equivalent required + Documented training as defined in the CLIA regulation 42CFR493.1489(b) + Non-degree semester hours in medical ... Responsible for a variety of routine and complex technical tasks in the performance of laboratory tests to obtain data for use in the diagnosis and treatment of disease. Principal Accountabilities: + Comfortable with emergency situations such as Massive… more
- Merck (Rahway, NJ)
- **Job Description** **BPR&D Downstream Principal** ** Scientist ** **Job Description:** Our Scientists are our Inventors. Using innovative thinking, state-of-the-art ... bioprocessing to join Biologics Process Research & Development (BPR&D) as a Principal Scientist . BPR&D within our company's Research Laboratories is on a mission to… more
- Merck (Rahway, NJ)
- …Analytical Chemistry in Development and Supply (ACDS) is seeking applicants for a Senior Scientist position available at the Rahway, NJ and West Point, PA sites. The ... small molecule drug product development and commercialization. The Senior Scientist responsibilities include, but not limited to, analytical method development… more
- Merck (Rahway, NJ)
- …join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist . BPR&D within Research Laboratories is committed to rapidly delivering diverse ... the scientific community to influence the field. As a Senior Principal Scientist , you will drive various strategic initiatives and translate strategies into… more
- Merck (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Principal Scientist . BPR&D within Research Laboratories is on a mission to rapidly deliver ... and engage with the scientific community to influence the field. As a Principal Scientist you will have the opportunity to influence the future direction of Upstream… 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
- 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 ... with regulatory filings (BLAs, NDAs) and Chemistry, Manufacturing, and Controls ( CMC ) processes. + Experience with high-performance computing. + Strong publication,… more