- Kelly Services (Vancouver, WA)
- Kelly(R) Science & Clinical is seeking a CMC Project Manager opportunity with a generative AI biotechnology company in Vancouver, WA. If you're passionate ... **Workplace:** Onsite in Vancouver, WA **Salary:** $95,000-130,000 **Overview** Drive CMC development, scale-up, cGMP manufacturing, and quality control for our… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Manager , Global Regulatory Affairs CMC Submission Management where you will ... CMC member on Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. You...CMC team, you will report to the Senior Manager GRA CMC and work with the… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Senior Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC strategies to ... **Essential Functions of the Job:** + Serve as the regulatory CMC representative on project teams. Provides CMC regulatory support and guidance for… more
- Gilead Sciences, Inc. (Foster City, CA)
- … teams. + Develop, implement, and document policies and procedures within the CMC regulatory affairs department under supervision of manager . Participates in ... create possible, together. **Job Description** **Sr Associate, Regulatory Affairs, CMC ** **Foster City, California** **Responsibilities:** + Develop and manage… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the ... point of contact to cross-functional teams on US/EU RA CMC project issues. + **Execution of Strategy...Leads US FDA/EU EMA interactions with support from higher-level manager . + **Regulatory Knowledge:** Demonstrates expert knowledge of US/EU… more
- GE Aerospace (Evendale, OH)
- …and manufacturing engineers in executing your priorities. You will also serve as a project manager and technical mentor for these team members, while getting ... role is within the Commercial Engines Ceramic Matrix Composite ( CMC ) Mechanical Design team in GE Aerospace's Engineering Division....Durham, NC assembly facility may be necessary. + Manage project plans and action plans for executing on component… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …will be responsible for the planning and execution of multiple small molecules and/or biologics CMC programs. The Sr. Project Manager will partner with PDM ... Manager , Project Management** **Location: Foster City** **Specific Responsibilities:** The Senior Project Manager in PDM Portfolio Strategy and Operations… more
- University of Rochester (Rochester, NY)
- …analyst. Technology specialist. Primary Symplicity software contact. The Data & Technology Manager reports to the Assistant Dean of the Benet Career Management ... Develop standard operating procedures, process maps, code manuals and project plans for all major reporting projects + Protect/ensure...as required for use by faculty, administration or internal CMC staff + Prepare monthly CMC dashboard… more
- Merck (Rahway, NJ)
- …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 (Rahway, NJ)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team AD representative or team lead). + Represent functional area on CMC project teams by communicating activities from designated functional area to ... or externally. + Identify and plan broader technical objectives ( project and scientific related) with input from manager...Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing… more
- AECOM (Fairbanks, AK)
- …Join us and let's get started. **Job Description** **AECOM** is seeking a **Construction Project Manager IV** to be based in one of the following locations: ... **Fairbanks, AK.** AECOM is seeking a highly qualified resilient Construction Project Manager to provide embedded on-site PM/CM support for Federal LPOE (Land… more
- Integra LifeSciences (Plainsboro, NJ)
- …are challenging what's possible and making headway to help improve outcomes. 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
- 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
- Insight Global (Boston, MA)
- …our pharmaceutical client based in Boston. The Operations and Continuous Improvement Manager for to support project portfolios, oversee change management, track ... proactive approach to enhancing efficiency. -Advanced knowledge of GMPs and CMC regulatory considerations in pharmaceuticals. -Proficiency in Smartsheet for tracking… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …If so, be empowered to take charge of your future at Takeda. Join us as a Manager of Statistics in our Cambridge, MA office. Here, everyone matters and you will be a ... vital contributor to our inspiring, bold mission. As a Manager of Statistics, you will be empowered to provide statistical leadership in the design, analysis, and… more
- Novo Nordisk (Boulder, CO)
- …and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Tesla Laboratories. Inc. (Salt Lake City, UT)
- …Requirements Qualifications include minimum 7 years total of design/construction project management and/or construction management. The personnel must be competent ... verify that construction and maintenance work is performed in accordance with project plans and specifications and according to industry standards of workmanship.… 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 Management (Evergreen Posting) Requisition ID: 67683 Date:...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical device life-cycle… more