- Merck (Rahway, NJ)
- …state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls ( CMC ) hub at our site headquarters in Rahway, NJ. This facility will be ... fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It is… more
- Bristol Myers Squibb (Princeton, NJ)
- …experience (20+years) of drug development or related experience managing clinical and CMC development under a variety of contexts; multiple clinical trials and ... operations required (ideally with pharma co and /or CRO) + A demonstrated track record of success leading, engaging, managing, and developing a large global multi-site, multi-cultural organization + Leadership experience of a large-scale enterprise… more
- Merck (Rahway, NJ)
- …state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls ( CMC ) hub at our site headquarters in Rahway, NJ. This facility will be ... fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It is… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces… more
- Organon & Co. (Jersey City, NJ)
- …science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project management and other partner groups as part of a ... development team to develop strategic early development plans (EDP). Importantly, the EDP will represent an integrated plan that leverages clinical pharmacology principles, such as establishing an exposure-response relationship to optimize dose selection,… more
- RWJBarnabas Health (Toms River, NJ)
- …West, Toms River, NJ 08755 Job Title:Pharmacy Technician Specialty Location: CMC Support Department Name:Pharmacy Req #:0000204794 Status:per hour Shift:Evening Pay ... Range: $24.05 - $30.28, per hour Pay Transparency: The above reflects the anticipated hourly wage range for this position if hired to work in New Jersey. The compensation offered to the candidate selected for the position will depend on several factors,… 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
- Baylor Scott & White Health (Trenton, NJ)
- …compartment) Hands:** Trigger fingers, Ganglions, Mallet fingers, Carpometacarpal ( CMC ) arthroplasty, , Dupuytren's (Palmar fascial fibromatosis), Amputations ... **Lower Extremity:** Hips:** Dislocation reductions, Total/partial Arthroplasty, Femoral fracture treatments, Arthroscopy Pelvis:** Fracture repairs Femur:** ORIF neck fractures, Trochanteric repairs, shaft fracture repairs Knees:** Dislocation… more
- Parexel (Trenton, NJ)
- …BSL2 (Biosafety Level 2) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified ... and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their… more
- Parexel (Trenton, NJ)
- …standard operating procedures (SOPs) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with ... qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet… more