- Parexel (Trenton, NJ)
- …be a 40-hour-per-week position. **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
- 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 ... to influence outcomes necessary. Sensitivity and experience with non-domestic organizations/cross-cultural environments. + Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously. + Must be… more
- RWJBarnabas Health (Toms River, NJ)
- …37 West, Toms River, NJ 08755 Job Title:Special Procedure Technologist Location: CMC Support Department Name:Cardiac Catheter Lab Req #:0000204292 Status:per hour ... Shift:Day Pay Range: $43.63 - $54.55, 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… more
- ThermoFisher Scientific (Lawrenceville, NJ)
- …to assimilate data and growing product knowledge into the broader aspects of CMC development and lifecycle management is a benefit. + Self-starter and must function ... well under minimal supervision. + Expert MS Office skills with a specific focus on word processing, formatting, tables, spreadsheets, presentations, graphics, slides, and templates, in addition to Adobe Acrobat. + Handle issues appropriately and with a sense… more
- Sanofi Group (Morristown, NJ)
- …and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated experience with preparation of ... (s)BLA/(s)NDA/MAA, INDs/CTAs, HA meeting briefing documents and negotiating with a national/regional HA preferred. + Experience on multidisciplinary matrixed project teams (eg clinical study team) preferred. + Project leadership experience preferred. **Why… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …+ Develop, establish, and complete the supply chain related tasks (eg distribution flow, packaging specification, artwork, packaging qualification, 3PL distribution ... **Overview** **Entrepreneurial Spirit, Rooted in Tradition** . Tanabe Pharma America, Inc. ("TPA") is a US subsidiary of Tanabe Pharma Corporation in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan's… more
- 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