- 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)
- …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)
- …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
- Sokol Materials & Services (Skillman, NJ)
- Assistant/Associate Scientist Job Location Seattle, WA Workspace On-site position (no remote or hybrid options) Target Hiring Date July 14, 2025 Work Authorization ... occasional shift work, weekends, and holidays. About the Role The Assistant/Associate Scientist /Engineer to join our Vector and Gene Delivery MS&T group in GDPAD.… more
- Merck (Rahway, NJ)
- …Combination Product Working Groups on cross-functional teams at the highest-level CMC teams and governance. + Serve as key point-of-contact with potential ... external device designers, developers, and suppliers for selected device technology platforms. + Oversee and serve as an integrator of all device development activities including engineering design, engineering analysis and testing, medical device design… more
- Sanofi Group (Morristown, NJ)
- …medicine, statistics, CMC , IA **Basic Qualifications:** + Medical doctor or doctor/ scientist + More than 5 years of clinical or scientific, or more than ... agreed clinical plans + Working in matrix with cross-functional R&D and CMC functions he/she ensures deliverables of preclinical, clinical and quality studies needed… more
- System One (Park Ridge, NJ)
- …strategies aligned with corporate innovation and compliance goals. The Principal Scientist must demonstrate a high level of autonomy, demonstrating ownership, ... + Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC + Strong knowledge of QbD principles and designing appropriate DOE studies to… more