- Bristol-Myers Squibb Company (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. Summary The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance ... drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics)...the following. Other duties may be assigned. Member of CMC Development Teams providing Quality (QA) input… 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)
- …( our Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC , and technical functions, to ensure timebound progression of ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non-clinical, Clinical, and… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and… more
- Eisai, Inc (Exton, PA)
- …with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics ... difference. If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- EPM Scientific (Rockville, MD)
- …investigations related to contamination and cleaning validation. Ensure high- quality , well-documented investigation reports. Drive the advancement of contamination ... Supply Chain (GSC), including the development of standards within the Quality Management System (QMS). Qualifications: Bachelor's degree in a relevant scientific… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …employment application is true to the best of my knowledge. Job Description Associate Director , Clinical Research, Value & Evidence Generation, US Medical ... reporting (eg, key product dashboards, financial aspects) are delivered with high quality and partner with TA Project Managers as necessary. Oversees & manages… 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 ... projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. **Essential… 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 ... Communicates regulatory decisions and strategy to stakeholders in development, manufacturing, and quality + Ensures that global CMC regulatory commitments are… 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...not limited to, small item sorters and carousels.Assures all quality checks and balances are implemented and maintained. +… 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
- 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 ... and/or supplemental applications and post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts as… more
- UTMB Health (Brazoria, TX)
- Mental Health Clinician - CMC - Clemens **Brazoria, Texas, United States** **New** Social Service UTMB Health Requisition # 2503824 The mission of Correctional ... 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 ... enters one of our facilities, will receive the highest quality care delivered at the right time, at the...members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific… 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 ... strategic initiatives with Contract Manufacturers (CMO) + In partnership with Quality , CMC , Procurement, Supply Planning to ensure manufacturing performance,… 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 ... Collaboration & Regulatory Contributions_ + Collaborate with Process Development, Regulatory, Quality , and external partners (CROs/CDMOs) to achieve CMC … more
