- Actalent (Lexington, MA)
- Responsibilities: The Contract Manager / Senior Manager - CMC QC will: * Support the external contract organization activities to fulfill the GMP QC ... testing needs * Provide internal support to CMC Operations to support the development, manufacture, and material...methods used for QC testing * Implement and maintain quality systems to ensure the integrity and reliability of… more
- Bristol Myers Squibb (Summit, NJ)
- …interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS- CMC senior manager will assess Manufacturing Change Controls for ... to address external questions regarding drug products. **Position Summary / Objective** The Senior Manager , GRS- CMC is responsible for content development,… more
- BeiGene (Emeryville, 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
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic...of submissions for Teva products, and for ensuring the quality of CMC response to global health ... a difference with. **The opportunity** The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and help develop regulatory strategies to support… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Manager uses CMC program management knowledge within the drug development industry to plan and lead the progress of assigned CMC projects/programs of ... advanced scope with limited guidance. As a Manager , CMC Program Management, a typical day...ensure programs meet scope, budget, and timeline while ensuring quality . + Develops strategic CMC program plan,… more
- WuXi AppTec (Philadelphia, PA)
- …part of cell and gene therapy product projects, ensuring timely and high- quality delivery. **Responsibilities** * Provide analytical CMC -related support for new ... products, analytical method development or transfer, qualification/validation, specification development, quality control testing in a cGMP environment, stability studies,… more
- RTX Corporation (Aurora, CO)
- …secure world. Job Summary: Raytheon, an RTX Company, is seeking a Finance Manager for the Constellation Management and Control ( CMC ) portfolio. This position ... will directly support the M2C2 program within the CMC portfolio, as the Deputy Finance Manager ...for efficiency, problem-solving, and resourcefulness, with a commitment to quality while developing their leadership skills as a key… more
- Intra-Cellular Therapies, Inc (New York, NY)
- …the CMC (Chemistry, Manufacturing and Controls) team of ITCI, **the** ** Senior Manager , Formulation Development** will be responsible for leading drug ... the Manufacturing and Supply Chain group of the ITCI CMC team. Responsibilities: + Lead and support activities for...veteran status, disability or any other legally protected status. Senior Manager , Formulation Development: Base Salary Range… more
- Bristol Myers Squibb (Summit, NJ)
- …a member of a cross functional team responsible for drug product related CMC strategy development. **Key Responsibilities** The Senior Principal Scientist will ... Product Development (DPD)** Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve… more
- Lauridsen Group Inc. (Ankeny, IA)
- The Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and international ... cross-functional teams, and stakeholders to develop and implement regulatory strategies. The Senior Manager of Regulatory Affairs is responsible for leading and… more
- Novo Nordisk (Watertown, MA)
- …+ Identify key stake holders and work collaboratively with cross-functional CMC , commercial, quality , regulatory, project management, legal, sourcing, supply ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...team based in Watertown, MA and report to the manager of the drug product outsourcing group. The team… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... requires collaboration at the Team Leadership level with the Development, Quality , Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy… more
- BD (Becton, Dickinson and Company) (Vernon Hills, IL)
- **Job Description Summary** The Senior Quality Engineer is responsible for supporting Design Quality Assurance within the Infection Prevention Platform: ... possible** with us. **General Functions, Specific Responsibilities, and Authority** **:** The Senior Quality Engineer works closely with shared functions (eg… more
- Novo Nordisk (Lexington, MA)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... lives for a living. Are you ready to make a difference? The Position The Senior Director can be accountable for the Clinical pharmacology strategy for phase 1-4 in… more
- RTX Corporation (Marlborough, MA)
- …Strategic Business Unit (SSBU) vision, and works with Consolidated Manufacturing Centers ( CMC ) to deliver Program results and will directly support a Program ... Secondary Strategic Business Unit (SSBU) vision, and works with Consolidated Manufacturing Centers ( CMC ) to deliver Program results. What You Will Do: + YOU WILL… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs, is responsible for the development and ... primarily to marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and… more
- BeiGene (Hopewell, NJ)
- …extensive cross-functional teams with hands-on experience across critical areas including CMC , Clinical & Commercial Production, PD/MST, Quality Management, and ... The General Manager , Biologics Manufacturing USA will be providing leadership...cross-functional teams with hands-on experience across critical areas including CMC , Clinical & Commercial Production, PD/MST, Quality … more
- Integra LifeSciences (Plainsboro, NJ)
- …us are challenging what's possible and making headway to help improve outcomes. This ** Senior Manager , Quality Operations** will manage and provide oversight ... agencies. **SUPERVISION RECEIVED** Receives minimal supervision from the Director, CMC Quality Operations. **SUPERVISION EXERCISED** Manages personnel supporting… more
- University of Miami (Miami, FL)
- …at the University of Miami Miller School of Medicine is actively seeking a dedicated Quality Assurance Manager to oversee the quality control and assurance ... in compliance with relevant regulatory standards and that the quality management system of the CRCMP complies with all...the renewal process + Responsible for working on the CMC sections of the IND, ensuring comprehensive documentation and… more
- The Arora Group (Bethesda, MD)
- …Manager (RN-NCM) + National Academy of Certified Care Managers: Care Manager Certified ( CMC ) + Experience: + Referral Management/Utilization Management ... Registered Nurse Case Manager Nurse Currently recruiting a Registered Nurse (RN)...services. + Utilize communication and available resources to promote quality and cost-effective outcomes, across the continuum of care.… more