- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... / our Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of portfolio, initiatives for… more
- Eisai, Inc (Exton, PA)
- …groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee ... Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and manage regulatory… more
- WuXi AppTec (Boston, MA)
- …of 5 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing. + Working knowledge and understanding of ... problems **Leadership Activities:** + Work closely with team members across all CMC -related business units and with the STA management team to ensure coordination… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics....the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD … more
- Boehringer Ingelheim (Ridgefield, CT)
- …We realize that our strength and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is responsible for ... supplemental applications and post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts as primary… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and ... manages the scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities… more
- UTMB Health (Huntsville, TX)
- …skills. **_SUPERVISION:_** + Received: Associate Vice President Pharmacy Services, CMC + Given:Assistant Director , Pharmacy Staff **_BUDGET RESPONSIBILITY:_** ... Director Pharmacy Service - CMC Huntsville...working conditions for the pharmacy staff. + Assists the Associate Vice President of Pharmacy Services with strategic plan… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Associate Principal Scientist ( Associate Director ) is responsible for developing and implementing Regulatory ... Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned small molecule and/or biological products...with global regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission… more
- UTMB Health (Brazoria, TX)
- Mental Health Clinician - CMC - Clemens **Brazoria, Texas, United States** Social Service UTMB Health Requisition # 2503824 The mission of Correctional Managed Care ... Works under the supervision of a Psychologist, Mental Health Manager and/or Program Director . **_ESSENTIAL JOB FUNCTIONS_** **:** + Contributes to the success of the… more
- Atlantic Health System (Pompton Plains, NJ)
- …medical laboratory technology/ medical or clinical laboratory science preferred + Associate 's degree in chemical, physical or biological science or medical ... all team members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific enhancements highlighted:… more
- Teva Pharmaceuticals (West Chester, PA)
- …small molecule specialty medicines, generics and over-the-counter therapies. The Associate Director at Bioassay Department of Biologics CMC leads a team of ... Associate Director , Binding and Cell-Based Bioassay - Onsite (West Chester, PA) Date: Jul 29, 2025 Location: West Chester, United States, Pennsylvania, 19380… more
- Merck (Upper Gwynedd, PA)
- **Job Description** GRACS CMC - Associate Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- J&J Family of Companies (Malvern, PA)
- …as a single submission. **We are searching for the best talent for an Associate Director , CAR-T Analytical Scientific Integrator - Advanced Therapies to be ... located in Malvern, PA or Leiden, Netherlands.** **Purpose:** The Associate Director , CAR-T Analytical Scientific Integrator will provide analytical, technical… more
- BeOne Medicines (Emeryville, CA)
- **_General Description:_** Sr. Manager/ Associate Director , Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... initiatives with Contract Manufacturers (CMO) + In partnership with Quality, CMC , Procurement, Supply Planning to ensure manufacturing performance, cost objectives… more
- AbbVie (Worcester, MA)
- …and digital strategy, influencing and driving end-to-end digital integration within Biologics CMC . This leader will collaborate closely with IT partners to evaluate ... TensorFlow, PyTorch, or similar) that are relevant to biologics CMC workflows. + Demonstrated ability to leverage AI and...ability to leverage AI and ML techniques for biologics CMC development to optimize processes, improve data analysis, and… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Drug Substance Commercial Development **Location** : Cambridge, MA **About the Job** Are you ready to shape the future of ... progress. The Commercial Process Development team, part of the CMC Synthetics Platform within the Sanofi R&D organization, is...join our growing Commercial Process Development team as an Associate Director . Under the direction of the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to bring Better Health and a Brighter Future to people worldwide. As an Associate Director in Analytical Development, you will lead efforts to develop advanced ... Process Development, Regulatory, Quality, and external partners (CROs/CDMOs) to achieve CMC objectives and meet program timelines. + Represent Analytical Development… more
