- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial… more
- Atlantic Health System (Pompton Plains, NJ)
- Under the direction of the Laboratory Director, the Manager , Laboratory Operations will coordinate and oversee a wide variety of administrative, personnel and ... and slack periods; making operational or staffing adjustments. Availability + The Laboratory Manager is not required to be on-site at all times testing is performed.… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by ... of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the supply chain activities ... in preparation, commercialization, and launch of new products in development in North American market (US and Canada) related to planning, procurement, label and packaging development, distribution, importation, export, and vendor management in cooperation… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- Sanofi Group (Morristown, NJ)
- …diseases and bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team supports Vaccine R&D ... support in R&D for pre-clinical work, bioassay and biomarker research and/or CMC , biological assay, and biomarker research. He/She will work in close collaboration… more
- Bristol Myers Squibb (Madison, NJ)
- …T he individual will provide technical expertise and leadership to Product CMC /Quality Teams to develop, implement, and manage the strategies for Quality to ... functions. + Supports the overall product quality strategy based on CMC deliverables, technical team objectives, life-cycle improvements, and regulatory commitments.… more
- RWJBarnabas Health (Toms River, NJ)
- …Location: 99 Highway 37 West, Toms River, NJ 08755 Job Title: RN Location: CMC Nursing Department Name: Nursing Float Pool Req #: 0000206931 Status: Hourly Shift: ... with the comforts of hometown care. Opened in 1961, CMC has evolved into the state's newest teaching hospital...Nurse is an individual practitioner and the interdisciplinary team manager , utilizes the nursing process to integrate all aspects… more
- Bristol Myers Squibb (Princeton, NJ)
- …Working knowledge of all functional areas of exploratory development (eg, chemistry/biochemistry, CMC ), late development, and commercial + Ability to create a clear ... + US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to...160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays… more
- Bristol Myers Squibb (Princeton, NJ)
- …in one or more key areas - Drug Development/ CMC /Pharmtox/ Biopharmaceutics/Clinical/Promotional. + Inter-dependent partnering skills, team-oriented and ability ... + US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to...160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays… more