- Merck & Co. (North Wales, PA)
- …mitigation measures. Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. Lead ... Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist /...include but are not limited to:Serve as a Regulatory CMC Project Lead and provide CMC… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies ... and the respective development stage of the project. The CMC Lead will support the Sr. ...holders, and SMEs to build and execute an effective CMC development strategy .- Leads special project(s)/committee(s) that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Policy team, through direct and indirect line management, to identify and lead global corporate initiatives, ensuring that DS is prepared to meet new or ... JP representatives. As part of leading Regulatory Intelligence, this role will lead the development and implementation of a global approach (incl. processes, roles… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference?The Position The Medical Director serves as the subject matter expert for our products and related data within ... a Therapeutic Are. The Medical Director is a team player, detail oriented with prior...Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for the treatment of primary hyperoxaluria. In doing so, the Senior Medical Director will work across different functional teams to support the design and execution ... Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
- Merck & Co. (Rahway, NJ)
- …the network to enable process and formulation development.- In this position, the SMAR&D Director will set guidance, lead activities, and develop a team whose ... and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control strategy...of Position:The Director reports to the Executive Director of SMAR&D and will lead a… more
- Insmed Incorporated (Bridgewater, NJ)
- …Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead ) in the pharmaceutical or biotechnology industry ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewOverview The Director , Toxicology, is a key member of the nonclinical safety team,… more
- Merck & Co. (Rahway, NJ)
- …in human through line of sight to commercial productionOversee and review CMC authoring activities for DP manufacturingEnsure successful and effective technology and ... implement innovative solutions to process analysis and control throughout the lifecycleAttract, lead , and develop a world-class team of scientists and engineers to… more
- Insmed Incorporated (Bridgewater, NJ)
- …optimization, clinical/commercial manufacturing, process characterization and validation, and manufacturing CMC development strategy . Remote (only in corp. ... programs. This position will be the dynamic cross-functional interaction between lead optimization research and early CMC development.Responsible for the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …organization leadership team. This individual will be responsible for a global operational strategy and investigations lead / owner for a best-in-class high ... immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head as part of the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC ... and the respective development stage of the project. The CMC Lead will support the Sr. ...holders, and SMEs to build and execute an effective CMC development strategy . - Leads special project(s)/committee(s)… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Sr Director , CMC Regulatory Affairs -Small Molecules** **KEY RESPONSIBILITIES** The ... Sr Director , CMC Regulatory Affairs for Small Molecules...with Gilead's global portfolio of small molecule products in CMC Regulatory Affairs. This position will lead … more
- Merck (North Wales, PA)
- …mitigation measures. + Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. + ... **Job Description** Under general supervision of an Executive Director /Senior Director , the Principal Scientist /...are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC… more
- Editas Medicine (Cambridge, MA)
- …regulatory success, and proposing risk mitigation measures. + Serve as a Regulatory CMC lead on relevant cross-functional or functional teams to provide ... with applicable EMA/FDA/ICH/WHO/Global regulations and regulatory guidance and guidelines. + Lead CMC related interactions with the health authorities including… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible...dossiers to be submitted to foreign Health Authorities. ⦁ Lead the review of internal CMC controlled… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... leadership and develop CMC regulatory strategy for global vaccine programs...require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization + Lead … more
- AbbVie (North Chicago, IL)
- …matrix management approach; Key member of Asset Strategy Team (AST) and ensures CMC strategy is closely aligned with the clinical and regulatory development ... strategy . Lead DevSci cross-functional initiatives and strategies....transfer to commercial manufacturing sites. Accountable for creating a CMC development plan in collaboration with line functions and… more
- AbbVie (North Chicago, IL)
- … CMC strategy is closely aligned with the clinical and regulatory development strategy . May lead multiple PPDST/ CMC teams from GLP tox through IND and ... PDD(s) and/or develops and implements PM or training tools. Lead R&D wide or DevSci wide initiatives and strategies...or DevSci wide initiatives and strategies Leads a global CMC team of functional representatives from various departments and… more
- AbbVie (North Chicago, IL)
- …scope. + Lead cross-functional PDS&T product teams and represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations functions, other ... or functions or outputs of this position. Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule… more
