- WuXi AppTec (Boston, MA)
- …STA Pharmaceutical, a WuXi AppTec Company, has an exciting opportunity for a ** Manager / Senior Manager , CMC Project Management.** This position ... will be responsible for managing DS and DP projects within STA. The position will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team. The… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial… more
- University of Michigan (Brighton, MI)
- Medical Assistant Senior ( CMC ) - Brighton Center for Specialty Care Apply Now **Mission Statement** Michigan Medicine improves the health of patients, ... work group. Acts as a key administrative resource in manager 's absence. + Relates work and job purpose to...Detail** **Job Opening ID** 263624 **Working Title** Medical Assistant Senior ( CMC ) - Brighton Center for Specialty… more
- BeOne Medicines (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
- Takeda Pharmaceuticals (Lexington, MA)
- …to reduce COGs and strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you PM support). + Continuous ... Description** **About the role** Join us as our **Global Manufacturing Sciences CMC Lead** and drive **high-impact, high-visibility CMC projects for innovative… more
- UTMB Health (Huntsville, TX)
- Technical Supervisor, Lab Serv - CMC - Estelle **Huntsville, Texas, United States** Allied Health UTMB Health Requisition # 2505527 The mission of Correctional ... workflow for the division; and communicate with staff, management, and senior leadership. **_ESSENTIAL JOB FUNCTIONS_** **:** . Responsible for recruitment, hiring,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …innovative company that will inspire you and empower you to shine? Join us as Senior Manager of Nonclinical Statistics in our Cambridge, MA office. As a ... Senior Manager of Statistics, you will provide...candidate will span across both Chemicals, Manufacturing, and Controls ( CMC ) and focused areas of drug discovery with specific… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **Title: Senior Manager , Commercial Biologics Product Science Lead** **Location: Lexington, MA ... large and diverse commercial biologics portfolio. In this role, you will be a senior subject matter expert across one or more products and provide strong technical… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Position: Senior Manager , Development to Launch Analytics** **Working with Us** ... questions and drive business strategy using advanced data science and analytics.** **The Senior Manager , Development to Launch Analytics will join a dynamic and… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senior Procurement Manager of CMO Category is responsible for establishing, managing and improving all aspects of purchasing ... Supply Chain, CMO Project Managers, Alliance Managers, Quality and CMC Development partners to ensure supply continuity with optimal...supply continuity with optimal cost and quality. Finally, the Senior Procurement Manager will help drive the… more
- Bausch + Lomb (Tampa, FL)
- …continue leading the advancement of eye health in the future. **Objectives/Purpose of Job:** The Senior Manager is a member of the Pharma and Lens Care Solutions ... Plastics and Packaging Engineering Team within the Pharmaceuticals/Consumer business vertical. The Senior Manager leads a team of Primary and Secondary Packaging… more
- Regeneron Pharmaceuticals (Warren, NJ)
- The ** Senior Manager , Clinical Drug Supply & Logistics** is responsible for providing oversight of individual or multiple clinical programs, forecasting ... as staff from quality, clinical compliance, regulatory, formulations, and IOPS ( CMC , external manufacturing, stability). **Supply Planning** + Serves as lead drug… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senor Manager , Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and ... process improvements to build the organization for the future. The Senor Manager , Clinical Supply Chain leads staff and provides leadership and guidance during… more
- Takeda Pharmaceuticals (Lexington, MA)
- …5+ years of experience + Must have exceptional working knowledge of CMC operations relating to research and development and investigational drug manufacturing. Must ... have direct management experience with external contract manufacturing organizations. + Demonstrated excellence in project management and effectively managing multiple projects/priorities. + Act as the key contributor in authoring Statements of Work in and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role** This senior individual contributor role in Global Manufacturing Science (GMSci) is the subject ... collaboration during troubleshooting and optimization. + Author and/or review key CMC and quality deliverables, such as: + protocols, validation reports, methods,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** **Title: Global Manufacturing Sciences BioProcess Lead (Sr. Manager )** **Location: Zurich, Switzerland / Lexington, MA** **About the role:** ... large and diverse commercial biologics portfolio. You will act as a senior subject matter expert across the biologics portfolio and provide technical expertise… more
- Kelly Services (Foster City, CA)
- ** Senior Clinical Program Manager ** + **Direct hire** + **Location:** Foster City CA: Hybrid work from home 2 days a week. _(Open to those willing to relocate at ... is looking for an onsite presence. **Position Summary** The Senior Program Manager will support the planning...a key role in cross-functional coordination across clinical, regulatory, CMC , and external partners. In addition to core program… more
- Boehringer Ingelheim (Duluth, GA)
- …strategic and operational initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving current processes and ... or to improve collaboration. The stakeholders will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership with RA project team… more