- 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. (Rahway, NJ)
- …Development Associate Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development (DD) ... , lead and set direction for the device development strategy for select development programs ranging from concept generation/selection through commercialization… 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
- 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 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
- 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
- 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
- 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
- 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
- Lilly (Philadelphia, PA)
- …related to radiopharmaceutical development and manufacturing and incorporate them into the CMC strategy . + Mentor and develop team members, providing coaching ... and supply chain teams, to ensure seamless execution of CMC strategies and activities. + Lead and...trials. + Develop, implement, and execute upon supply chain strategy for materials needed for manufacturing of PET radiopharmaceuticals… 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
- Pfizer (Groton, CT)
- …and develop drug candidates from early phases of development to commercial launch. As a Director in the group you will lead a team of analytical scientists to ... development projects + Define and drive the analytical development strategy in full alignment with the other CMC...and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's… more
- Merck (Rahway, NJ)
- …Development Associate Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)** _Our company's Device Development ... , lead and set direction for the device development strategy for select development programs ranging from concept generation/selection through commercialization… more
