Regulatory and Chemistry, Manufacturing and Control (CMC) related expertise for development and commercial stage products... priorities. This role represents a unique opportunity to contribute to Regulatory CMC activities supporting maintenance...
Job Description General Summary: The Director, Regulatory CMC leads a cross-functional team in the execution... of global regulatory CMC strategies for investigational and marketed cell and gene therapy products. This role is accountable...
Job Description: We are seeking a Contract Manager, CMC Project Management to support Commercial and Early-Stage... program initiatives within the Chemistry, Manufacturing, and Controls (CMC) domain. This role involves managing and updating...
We are seeking a Contract Manager, CMC Project Management to support Commercial and Early-Stage program initiatives... related to Life Cycle Management. Collaborate with CMC leads and cross-functional partners (Regulatory Affairs, Manufacturing...
Industry: Pharmaceuticals Title: Manager, CMC Project Management Job ID: CAMB000023 Location: Cambridge (Hybrid: 2–3... of Commercial programs Work together with Commercial CMC leads and expertise areas (Regulatory Affairs, Manufacturing...
, site QA/QC, and regulatory CMC) and commercial functions (i.e., AS&T, MS&T, QC, QA Operations, Supply Chain) to enable..., etc.) are used. Support preparation of CMC clinical and commercial regulatory submissions by critically reviewing and approving...
of life for patients, caregivers, and families. Job Description The Senior Clinical Project Manager/Clinical Project... Manager is a team-player role responsible for supporting aspects of clinical operations for our programs. This individual...
. Strong understanding of clinical blinding practices, IRT systems, and global regulatory requirements. Excellent project management.... Creating and maintaining clinical supply forecasts, ensuring alignment with Clinical and CMC teams. Identifying and mitigating...
Job Description This Commercial Manufacturing and Supply Chain (CMSC) Senior Project Manager will be responsible... for supporting the cross-functional project teams executing our development CMC and CMSC strategies within the POVE program. The...
. Guidelines and internal procedures. Work with CMC technical SMEs and Regulatory to prepare and review QC related sections of IND..., including Analytical Development, AS&T, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance...
Materials Manager (CHMM), Certified Safety Professional (CSP) and/or Certified Microbial Consultant (CMC) licenses are preferred... an experienced Hazardous Building Materials/Industrial Hygiene Senior Project Manager to join our Greater Boston, MA Offices...
solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing... technologies. The Sales Manager will use their knowledge of science and the business including corporate contacts to develop...
Job Description General/Position Summary The Senior Manager Manufacturing Technical Sciences QA is accountable... standards for current or novel technologies, ensuring internal and cross-functional alignment with industry and regulatory...
Job Description General/Position Summary The Director, CMC Inspection Management as part of the Vertex Quality... Assurance Organization is responsible for the inspection management related to CMC activities of the internal manufacturing site...
preclinical, clinical, regulatory, translational, biomarker, diagnostics, CMC, and clinical development plans through to approval... accountability for strategy, goals, and deliverables. In partnership with the program manager and core team, develop and implement...
for quality and compliance with GxP regulatory requirements, and guidances, etc. Partners with QA leadership and business... knowledge of GxP regulations CMC documentation Investigation, root cause analysis, and effectiveness check processes, tools...
. Research, Analytical Development, CMC, Clinical/Non-Clinical, Quality, Regulatory, etc.) Demonstrates a high sense of urgency... solutions that positively impact patient lives. As an experienced Project Manager, you will provide strategic guidance and drive...
, an analytical strategy to support product commercialization Contributing to the regulatory CMC strategy and the preparation... Director specializing in analytical CMC strategy to provide scientific leadership within and across functional areas. The...
effective and compliant processes and systems to maintain continuous level of regulatory compliance and successful outcome... from regulatory inspections. The role will be responsible for working with internal and external stakeholders in a matrix environment...
Development in the cross-function CMC team and actively contribute to defined deliverables and milestones for programs... clearly and concisely Author or contribute to technical documents including regulatory submissions, internal guidance...