- Integra LifeSciences (Plainsboro, NJ)
- …applicable regulatory agencies. **SUPERVISION RECEIVED** Receives minimal supervision from the Director , CMC Quality Operations. **SUPERVISION EXERCISED** ... what's possible and making headway to help improve outcomes. This ** Senior Manager, Quality Operations** will manage and provide oversight on Quality … more
- Integra LifeSciences (Plainsboro, NJ)
- …headway to help improve outcomes. **SUMMARY** Under the direct supervision of the Director , Quality Reliability Microbiology, this individual will have a dotted ... line reporting structure to the local site quality leader. Responsibilities associated with this Sr . Microbiologist include interpreting microbiological testing… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take main responsibility for … more
- Merck (Rahway, NJ)
- …GLOBAL REGULATORY CMC Biologics (R5)** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is ... responsible for developing and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product franchises in… more
- Bristol Myers Squibb (Summit, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Sr . Manager / Associate Director , Global Sterility Assurance CTTO** ... at BMS with our Cell Therapy team. T he ** Sr Manager/Associate Director - Sterility Assurance, Cell...Cell Therapy . + Experience with regulatory inspections and CMC + Experience with Quality Management System.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring … more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director Clinical Development - Respiratory Date: Sep 29, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job ... be based in Parsippany, NJ or West Chester, PA Senior Director , Clinical Development is responsible for...Brochures, clinical study reports, summaries for regulatory submissions). The Sr . Director , Clinical Development will provide input… more
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Medical Director , US Lymphoma/CLL will report to the ... will lead the US medical Lymphoma team supporting the MM/Lymphoma Disease Lead. The Senior Medical Director will provide key contribution for the overall medical… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called upon ... plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also...claims. + Acts as liaison between Regulatory Affairs & CMC and other functional areas, including external contractors (eg,… more
- Merck (Rahway, NJ)
- …have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non-clinical, Clinical, and ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Integra LifeSciences (Plainsboro, NJ)
- …are challenging what's possible and making headway to help improve outcomes. The Director , Manufacturing is a key member of the plant leadership team responsible for ... leading the overall manufacturing operations for Integra's Collagen Manufacturing Center ( CMC ), working within FDA medical device regulations and ISO Standards.… more
- Bristol Myers Squibb (Summit, NJ)
- …careers.bms.com/working-with-us . **Position Summary:** Bristol-Myers Squibb is seeking a Product Quality Leader (PQL), Associate Director of Global Product ... individual will provide technical expertise and leadership to Product CMC / Quality Teams to develop, implement, and manage...rational manner, and demonstrated ability to work as a senior management team member and to engage and influence… more