- Actalent (Waltham, MA)
- Job Title: CMC Project ManagerJob Description We are seeking a highly skilled CMC Project Manager to join our team. This individual will partner with ... Skills + CMC development and product development experience. + CMC project management and program management expertise. + Experience in cell therapy… more
- Actalent (Waltham, MA)
- Description: We are looking for an experienced CMC operations manager to join our team as Contract Manager , CMC Operations, managing CMC activities ... of clinical pipeline. The ideal candidate should have relevant experience in CMC product development and project management, and enjoy fast-paced, collaborative,… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid role ... within CMC Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change management,… more
- Amgen (New Albany, OH)
- The Regulatory Affairs CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products ... manufactured at or planned for the specific site. The CMC site team interfaces with the site (R&D and...computer skills, including word processing, database document repository and project management software + Able to influence vertically and… more
- Regeneron Pharmaceuticals (Troy, NY)
- …assembly of responses to regulatory agency inquiries. + Act as the project manager related to program submission strategies, including timelines, approach, ... We are seeking a highly motivated and experienced Staff CMC Regulatory Sciences Specialist (Commercial Submissions) to join our...may be for you if you have: + Strong project management and communication skills. + Ability to work… more
- Leidos (Webster, TX)
- **Description** Leidos has an excellent opportunity for an experienced Project Manager on the Cargo Mission Contract ( CMC ) in support of Exrtravehicular ... Coordinate with performing orgs and Technical Integration and Partnerships (TI&P) business manager . + Communicate project scope, objectives, and progress to team… more
- UTMB Health (Conroe, TX)
- Program Mgr, Nursing Quality & Informatics CMC - Conroe **Conroe, Texas, United States** **New** Nursing & Care Management UTMB Health Requisition # 2501498 The ... Texas Juvenile Justice Department (TJJD). **_JOB SUMMARY_** **:** The Program Manager for Nursing Informatics and Quality bridges the gap between nursingpractice,… more
- Integra LifeSciences (Plainsboro, NJ)
- …Microbiology, and Sterility Assurance department and working with the ** CMC Plainsboro, NJ** Integra manufacturing site. Qualified candidates must possess ... coordination, material allocation and alignment of personnel to successfully complete project assignments. + Create site procedures for microbiological testing and… more
- Merck (West Point, PA)
- …arms within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck (West Point, PA)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs...preferred. + At least 8 years of experience in project management. + At least 5 years of experience… more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Senior Project Manager ** is a key member of the value stream leadership team ... for Integra's Collagen Manufacturing Center ( CMC ) in Plainsboro, NJ. Reporting to the assigned value...Plainsboro, NJ. Reporting to the assigned value stream manufacturing manager , this position is responsible for leading cross-functional teams… more
- Shuvel Digital (Reston, VA)
- …Certifications + IT and Technology-Specific Certifications + Certified Information Systems Project Manager (CISPM) + ITIL Certification (Information Technology ... of program financial performance. Develop and deliver required contract, departmental, project and/or financial reports. Program Planning and Strategy + Project… more
- Merck (West Point, PA)
- …Management Section of the GCS Planning organization. Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary:** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the ... IB, NDA, Amendments, Supplements, Briefing Books) for review by higher-level manager . This position demonstrates understanding of key regulatory guidances and their… more
- Vera Therapeutics (Brisbane, CA)
- …with other functional areas including Clinical Operations, Biometrics, Pharmacology and CMC . * Project manage early-stage development activities including within ... Title: Associate Director, Project Management Location: Brisbane, California About Us: Vera...and staffing companies) are prohibited from contacting our hiring manager (s), executive team members, or employees. We require that… more
- WSP USA (New York, NY)
- …in the office 5 days a week role. **Your Impact** + Serve in a Program/ Project Manager role on highly visible major transportation projects delivered via various ... Extensive Design project delivery experience as a Project /Program Manager + 25+ years of relevant...Qualifications: + Engineering or Architecture License + PMP or CMC Certification **Expected Salary: $270,000 - $385,000** WSP USA… more
- West Pharmaceutical Services (Exton, PA)
- …and current state-of-art standards/regulations. + Collaborate with regulatory lead(s), cross-functional project manager (s) and SMEs (Subject Matter Experts) in ... Sr. Specialist, Regulatory Project Mgmt Requisition ID: 66496 Date: Mar 5,...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical device life-cycle… more
- Leidos (Webster, TX)
- **Description** Leidos has an opportunity on the Cargo Mission Contract ( CMC ) in support of EHP programs. In this position, the employee will be located onsite at ... will be required. Overview: The Government Furnished Property (GFP) Project Integration Lead will be responsible for overseeing and...GFP integration. + Serve as backup to the GFP Manager in chairing the EHP GFE Integration Team, providing… more
- Fresenius Medical Center (Knoxville, TN)
- The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as regulatory ... expert development and new registration projects (Medicinal Products) + Project management for the implementation of projects to comply with regulatory requirements… more
- AbbVie (North Chicago, IL)
- …R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. ... be able to perform research along with directing research and/or project activities by effectively mentoring, guiding and/or supervising scientific personnel. Should… more