- Merck & Co. (Rahway, NJ)
- …colleagues while developing and expanding your career.The Chemistry, Manufacturing & Controls ( CMC ) Pre-approval Pharm Executive Director is accountable for ... CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery...compliant and available to patients in markets as needed.-The Executive Director of CMC Pre-approval… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and ... their assigned projects. Position Description- The Principal Scientist / Director responsibilities include but are not limited to:Serve as...responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide … more
- Insmed Incorporated (Bridgewater, NJ)
- …, Toxicology is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and Molecular Mechanisms. In this role, you ... discipline. DABT/DACVP certification preferred.Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Merck & Co. (Rahway, NJ)
- …across the organizations (Research Division/Manufacturing Division), such as Analytical, Quality, Regulatory CMC , and technical functions, to ensure timebound ... and stakeholders in development is expected.The Director will report to the Executive Director of Oral Formulation Sciences and will have approximately 10-15… more
- Insmed Incorporated (Bridgewater, NJ)
- …, Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and Molecular Mechanisms. In this role, you ... discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …understanding of Pharma or life sciences manufacturing processes, cGMP practices, regulatory health authority CMC requirementsExperience with federal subsidy ... Position Summary The Director of Project Management will lead a team...promote project transparencyPrepare and deliver reports and presentations to executive leadership and other stakeholders Experience Requirements Ten (10)… more
- Merck (Rahway, NJ)
- …colleagues while developing and expanding your career. The Chemistry, Manufacturing & Controls ( CMC ) Pre-approval Pharm Executive Director is accountable for ... CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery...and available to patients in markets as needed. The Executive Director of CMC Pre-approval… more
- 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 (Summit, 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
- ThermoFisher Scientific (Wilmington, NC)
- …on - now and in the future. **Discover Impactful Work:** The Senior Director , Regulatory Affairs Functional Lead, FSP, provides strategic direction, leadership ... in a regulatory affairs function and speciality area (preclinical, clinical, CMC , publishing, etc) + A demonstrated track record of success in leading,… more
- Bristol Myers Squibb (Madison, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Position:** Executive Medical Director - Disease Lead US Medical Affairs, ... Research and Development + Statistics + Translational Research + Regulatory Affairs including CMC - Regulatory + Manufacturing and Quality teams + Project… 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
- 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
