- Integra LifeSciences (Plainsboro, NJ)
- …Operations** is responsible for the medical dispersion production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality ... of our medical devices. This includes assigning and monitoring daily 2nd shift activities of production staff and partnering with other support departments to efficiently and compliantly complete work and work processes as per outlined production schedules.… more
- Parexel (Trenton, NJ)
- …update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes). * Execute timely data entry and validation in Veeva Vault RIMS ... for submissions and approvals. Regulatory Submissions * Review, prepare, and submit dossiers; negotiate with HAs to secure approvals. * Provide local input for change control and post-approval requirements. * Collaborate with global functions to obtain… more
- Sanofi Group (Morristown, NJ)
- …products within the Sanofi portfolio of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a ... critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and… more
- Merck (Rahway, NJ)
- …scientists, clinical and medical leads, regulatory affairs, clinical operations, and CMC teams. + **Reporting & dissemination** : Interpret imaging data, author ... study reports, present findings internally and externally, and contribute to manuscripts and conference presentations. **NOTE: This role is available in South San Francisco, CA; Boston, MA; West Point, PA or Rahway, NJ based on candidate preference.**… more
- Sanofi Group (Morristown, NJ)
- …products within the Sanofi portfolio of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a ... critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and… more
- Integra LifeSciences (Plainsboro, NJ)
- …equipment, and loop calibrations of various parameters used within the CMC 's manufacturing operations, laboratories, and facilities. + Excellent communication and ... problem-solving skills + Use manual and powered electrical repair and diagnostic tools/ instruments skillfully. + Complete all cGMP documentation associated with calibration and maintenance tasks. + Review calibration SOPs for accuracy during routine… more
- Parexel (Trenton, NJ)
- …regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life Sciences, Chemistry, ... Engineering, or related pharmaceutical field; advanced degree (MSc, PhD, PharmD) preferred. * Minimum 5 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations with global responsibility. * Experience leading teams in… more
- Atlantic Health System (Pompton Plains, NJ)
- …communicate this to the Radiologist as necessary. Images patients using the CMC patient identification policy prior to imaging. Performs Clinical MRI examinations: ... Scans patients according to set protocols and radiologist special requests. Identifies patients using Patient Identification Policy. Presents examinations to radiologist for interpretation. Ensures proper tracking in RIS by the staff. Makes all efforts to… more
- Merck (Rahway, NJ)
- …design / modeling. + Familiarity with drug development cycle, especially the CMC (Chemistry, Manufacturing, and Control) aspect, with skills to help advance our ... digital effort in this area. + Familiarity with biocatalysis, protein engineering, biotherapeutics, and / or vaccines is advantageous. + Knowledge and experience in downstream process development, such as flocculation, microfiltration, ultrafiltration,… more
- RWJBarnabas Health (Toms River, NJ)
- …Highway 37 West, Toms River, NJ 08755 Job Title:Director Location: CMC Support Department Name:Cancer Center Administration Req #:0000204761 Status:Salaried Shift:Day ... Pay Range: $127,000.00 - $179,400.00, Annual Pay Transparency: The above reflects the anticipated annual salary 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… more