- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategy & Investigations Owner/ Lead as part of ... This individual will be responsible for a global operational strategy and investigations lead / owner for...or related field. Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly… 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)
- …culture, talent development, technology introduction, and compliance.- However, one co- lead remains focused on non-sterile pipeline programs and infrastructure while ... one co- lead remains focused on sterile pipeline programs and infrastructure.-...drivers of change, translating that to a local FLEx strategy , securing support for that strategy with… more
- Merck & Co. (Rahway, NJ)
- …for a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy , lead activities, and develop a ... organizations (Research Division/Manufacturing Division), such as Analytical, Quality, Regulatory CMC , and technical functions, to ensure timebound progression of… 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
- Insmed Incorporated (Bridgewater, NJ)
- …preferred.Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead ) in the pharmaceutical or biotechnology ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical safety team, reporting… more
- Insmed Incorporated (Bridgewater, NJ)
- …preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead ) in the pharmaceutical or biotechnology ... preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead ) in the pharmaceutical or biotechnology… 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
- Taiho Oncology (Pleasanton, CA)
- …an agreed upon plan. Performance Objectives: + Independently develops global regulatory CMC Strategy and Risk Assessments, and communicate such strategy ... Director , Regulatory Affairs CMC Pleasanton, CA,...will play a pivotal and visible role in advancing CMC filing strategy for investigational/ developmental products… 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
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC ... an advisor/liaison to senior management to plan, evaluate and recommend implementation strategy . Establish collaboration with Global CMC teams and leadership… 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 , Innovative Medicine (Hybrid) Date: Apr 26, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to...CMC (Innovative Medicine) you will: + Influence the strategy and assess the quality of documents for regulatory… 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
- BeiGene (San Mateo, CA)
- …on programs from a pre-clinical stage through clinical proof of concept. + Lead cross-functional team to author CMC / quality sections of regulatory submissions ... We are seeking an exceptional and highly motivated CMC leader to join the BeiGene Cell Therapy...for cell therapy trials. + Develop a vendor selection strategy to select services for development and manufacturing of… more
- AbbVie (South San Francisco, CA)
- …and LinkedIn. Job Description Position Description: For the Biologics Drug Product R&D Director position, we are seeking a highly motivated, experienced leader to ... lead a diverse team of pharmaceutical development scientists supporting...bar for the team. + Actively contribute to cross-functional CMC strategic discussions, ensuring drug product development plans are… more
- Gilead Sciences, Inc. (Foster City, CA)
- …We empower our leaders to step up, share ideas, listen, learn, and lead . We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster ... 35 countries worldwide, with headquarters in Foster City, California._ **Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The Sr Director… more
- AbbVie (North Chicago, IL)
- …Biologics CMC to deliver high-quality drug products for patients. The Director , Biologics ARD will lead the Analytical Development-Early Phase group within ... within Biologics Analytical R&D and in line with the Biologics CMC Development/AbbVie strategy for NBEs. + Recruit, promote, and retain top talents via… more
