- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the ... supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Control Teams ( CMC ) to enable R&D Development Team objectives/deliverables. **Position:** Senior Manager , CMC Project Operations **Location:** New ... appropriate allocation of DS and API materials for non-clinical use. + The CMC Project Manager may co-lead and/or contribute to Product Development portfolio… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the ... point of contact to cross-functional teams on US/EU RA CMC project issues. + **Execution of Strategy...Leads US FDA/EU EMA interactions with support from higher-level manager . + **Regulatory Knowledge:** Demonstrates expert knowledge of US/EU… more
- Integra LifeSciences (Plainsboro, NJ)
- …implementing procedures, and remediation projects. The candidate must be a senior -level professional/team player with advanced knowledge and experience who thrives ... Microbiology, and Sterility Assurance department and working with the ** CMC Plainsboro, NJ** Integra manufacturing site. Qualified candidates must possess… more
- Integra LifeSciences (Plainsboro, NJ)
- …4,000 of us are challenging what's possible and making headway to help improve outcomes. The ** Senior Project Manager ** is a key member of the value stream ... leadership team for Integra's Collagen Manufacturing Center ( CMC ) in Plainsboro, NJ. Reporting to the assigned value...goals and ensure successful execution. Provide regular updates to senior management on project status, performance metrics,… more
- Merck (Rahway, NJ)
- …Management Section of the GCS Planning organization. Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Actalent (Edison, NJ)
- Job Title: Senior Program Manager Job Description The incumbent will lead a team of program management professionals, spearhead key organizational growth ... complex drug development activities for cross-functional development projects, including the project management of CMC , clinical, and regulatory activities.… more
- Merck (Rahway, NJ)
- …the Development Sciences and Clinical Supply (DSCS) organization, the Digital Program Manager will advance the purpose and aspiration of our Company's DSCS Digital ... robustness across organizational deliverables. In this role, the DSCS Digital Program Manager will provide strategic and tactical direction and partner with the DSCS… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete clinical supply ... but not limited to, Clinical Operations, Chemistry, Manufacturing and Controls ( CMC ), Product Quality Assurance (PQA),Regulatory Affairs and Sourcing departments. +… more
- System One (Florham Park, NJ)
- …for process improvements. In addition to these standard publishing requirements, the Senior Regulatory Operations Associate will bring project management skills ... Senior Regulatory Operations Associate Contractor (Publishing) Must be...implement Regulatory Operations' initiatives by attending and participating in Project Teams if deemed appropriate by manager .… more
- Merck (Rahway, NJ)
- …Global Human Health (GHH) brand/ franchise commercial goals. The Biologics VCM Product Manager (PM) works under direction of the VCM Product Leader supporting the ... for one or more Biologics products. The VCM Product Manager will be responsible for supporting supply chain design,...key investments across the product supply chain, assure key project execution, and drive year on year attainment of… more
- Integra LifeSciences (Plainsboro, NJ)
- …are challenging what's possible and making headway to help improve outcomes. This ** Senior Manager , Quality Operations** will manage and provide oversight on ... for change control projects and daily operations which may include leading project teams focused on key initiatives including quality process improvements, process… more
- Amicus Therapeutics (Princeton, NJ)
- …Management represents Program Management in the Brand Leadership Team. A Manager , Program Management provides support to the Executive Director, Program Management ... by partnering with key stakeholders including but not restricted to CMC , Clinical, Clinical Operations, Regulatory, Patient Advocacy, IP/Legal, Finance. 4. Risk… more
