- Taiho Oncology (Pleasanton, CA)
- …and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive Director , Regulatory CMC . ... Director , Regulatory Affairs CMC ... Director , Regulatory Affairs CMC Pleasanton, CA, USA... activities of external consultants in consultation with Global Executive Director or designee. + Prepare project… more
- Takeda Pharmaceuticals (Boston, MA)
- …CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. **How you ... regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence… more
- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing ... their assigned projects. **Position Description** **The Principal Scientist / Director responsibilities include but are not limited to:** +...but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide … more
- BeiGene (San Mateo, CA)
- …stage through clinical proof of concept. + Lead cross-functional team to author CMC / quality sections of regulatory submissions (INDs/CTDs). + Building scope and ... processes and analytics for cell therapy products. + Assembling relevant CMC data and authoring regulatory filing documents ( CMC sections) and responses to… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …Master in Management (MiM) Program. Reporting to the Assistant Dean & Executive Director for the Undergraduate Career Management Center and collaborating ... of our academic community. **Description** The Goizueta Business School is seeking a Director to lead the career development and recruiting efforts for the newly… more
- Bristol Myers Squibb (Summit, NJ)
- …at work 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 ... across vector programs + Review/author technical sections of major regulatory documents and contribute to the overall CMC...requests to support the product globally. **Basic Qualifications** + Executive Director level: BS, MS, PhD in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …direct impact. Join Gilead and help create possible, together. **Job Description** The Executive Director of Cell Culture Development (CCD) will be responsible ... control strategy in partnership with organizations across Technical Development, Quality, Regulatory Affairs CMC , and Manufacturing. + Support regulatory… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Executive Director , Analytical Strategy and Operations (ASO) reports ... extensive internal and external analytical network. As an enterprise leader, the Executive Director is responsible for stability testing and technical writing… more
- Bristol Myers Squibb (Devens, MA)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Executive Director , CT Technical Operations Drug Product will have global ... the cell therapy global manufacturing network. This role collaborates with Manufacturing, CMC , Regulatory , SC, Quality, QC, F&E, Process Development, Analytical… more
- Merck (Rahway, NJ)
- …compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program support, financial, talent ... functional groups in development, quality, safety, facilities management, analytical, finance and regulatory . FLEx was designed to be a facility that evolves to meet… more
- Lilly (Indianapolis, IN)
- …products, and etc.) at all stages of development. **Position Brand Description:** The Director /Sr Director / Executive Director of Upstream Process ... portfolio. + Author and review CMC documentation including CMC sections of regulatory submissions, technical reports crucial for filing and responding to… more
- Merck (Rahway, NJ)
- …across the organizations (Research Division/Manufacturing Division), such as Analytical, Quality, Regulatory CMC , and technical functions, to ensure timebound ... stakeholders in development is expected. The Director will report to the Executive Director of Oral Formulation Sciences and will have approximately 10-15… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …input into the Clinical Development Plan, and it requires collaboration with clinical, regulatory , medical, CMC and Global Insights. + **Global Brand Strategy & ... Sr Director , Global Launch Readiness - Immunology Date: Apr...& Cross-Functional Leadership** , including partnership with R&D, Medical, Regulatory , Global Insights & Analytics, and coordination with regions… more
- Bristol Myers Squibb (Devens, MA)
- … Director of Validation, Cell Therapy Technical Operations reports to the Executive Director , Drug Product Cell Therapy Technical Operations within the Cell ... impact assessments and risk assessments. + Author and review CMC summaries of validation for worldwide regulatory ...review CMC summaries of validation for worldwide regulatory submissions for initialization and life-cycle changes. + Design… more
- AbbVie (Irvine, CA)
- …Research Group at AbbVie seeks an accomplished scientist and leader. The Director /Senior Principal Research Scientist will lead a team performing in vivo ... productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from early-stage… more
- Lilly (Cambridge, MA)
- …significant improvements in healthy outcomes for our customers. We are seeking an Executive /Senior Director - DDCS Drug Delivery and New Product Innovation to ... the Medicines Innovation Hub and the Business Units, as well as leaders in Regulatory and Manufacturing to define and deliver our strategy. This individual will be… more
- AbbVie (North Chicago, IL)
- …and device types + Collaborate with cross-functional leadership and executive management to drive organizational excellence and process improvement Qualifications ... of the organization Key Stakeholders: Key stakeholders include Drug Product CMC (Chemistry, Manufacturing and Controls), Operations / Science & Technology,… more
- UTMB Health (Dallas, TX)
- …**_JOB SUMMARY_** **:** Works under the direction of the Associate Medical Director . **_ESSENTIAL JOB FUNCTIONS (Medical Director )_** **:** + Contributes to ... and recommends institutional policies and procedures that will enable UTMB CMC to maximize Digital Medical Services/Telemedicine. + Contributes to the development… more