- Merck & Co. (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
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …functional partners.Key Responsibilities Represent MSAT at joint quality and CMC committeesPartner closely with senior Janssen leadership to achieve global ... in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical...extend to participation in a variety of cross functional CMC and quality forum under the Joint… more
- Aequor (New Brunswick, NJ)
- …as with business partners such as IT. This role will report to the Sr Director , Product Development Strategy. Responsibilities Collect and curate data from ... Fri, Business Hours Product Development (PD) at is committed to accelerating CMC development to launch through strategic investments in Client development and… 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
- 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
- Bristol Myers Squibb (Summit, NJ)
- …better place than here at BMS with our Cell Therapy team. The ** Senior Director , Cell Therapy Manufacturing Technology** leads a cross-functional team ... in Summit, NJ to ensure rapid, flawless, compliant, and cost-effective delivery of quality products. This is a critical role to ensure timely qualification of the… 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
- 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
