- 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: Mar 28, 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
- 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
- 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
- Bristol Myers Squibb (Summit, NJ)
- …Review/author technical sections of major regulatory documents and contribute to the overall CMC strategy of the current vector technologies and future gene ... and in their personal lives. Read more: careers.bms.com/working-with-us . The Executive Director of Cell Therapy Vector Operations will report to the Vice President… 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
- Bristol Myers Squibb (Madison, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Position:** Executive Medical Director - Disease Lead US Medical Affairs, Multiple ... companies, and make a difference. Position Summary The Disease Lead , US Medical, Multiple Myeloma/Lymphoma will report to the...Medical, MM/Lymphoma will be responsible for the overall medical strategy in the US, in alignment with overall US… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Director , Pharmacometrics & Biopharmaceutics Lead is responsible for devising the program-level modeling and simulation ... strategy and providing oversight thereof. The responsibility includes identification...technical aspects of modeling efforts and modeling reports. The Director , Pharmacometrics & Biopharmaceutics also will have responsibility for… more
- Bristol Myers Squibb (Devens, MA)
- …than here at BMS with our Cell Therapy team. **Position Summary** The Director of Validation, Cell Therapy Technical Operationsreports to the Executive Director , ... serve as the Global Technical SME for Drug Product and Vector Validation. The lead will develop global technical standards for cell therapy validation and deploy the… more
- Bristol Myers Squibb (Seattle, WA)
- …group plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external and internal manufacturing ... cell therapy manufacturing network. We are looking for a director to join our Process Robustness team within the...Therapy Technical Operations Function. The successful candidate will will lead a matrixed cross functional team to enable process… 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 ... Join Gilead and help create possible, together. **Job Description** The Executive Director of Cell Culture Development (CCD) will be responsible for leading the… more
- Lilly (Indianapolis, IN)
- …and etc.) at all stages of development. **Position Brand Description:** The Director /Sr Director /Executive Director of Upstream Process Development will ... a collaborative, intellectually stimulating, and fast-paced work milieu. **Responsibilities:** + Lead and manage a proficient team of scientists and engineers… more