- Larimar Therapeutics (Philadelphia, PA)
- …win the day - we welcome you! Position Summary: Larimar is seeking a CMC Regulatory Affairs Director to provide professional experience and leadership supporting ... Affairs Senior Director . Job Duties/Responsibilities: Larimar Team Membership The Director of CMC Regulatory Affairs will be a key member of the regulatory,… more
- Unknown (Boston, MA)
- …and requirements, providing expertise and guidance to the client contact for CMC development teams. The Director will also lead regulatory intelligence ... The Director will collaborate cross-functionally with internal teams to...collaborate cross-functionally with internal teams to ensure alignment of CMC regulatory strategies with overall development plans and corporate… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing the ... supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and manufacturing/supply processes Understands,… more
- Formation Bio (New York, NY)
- …more efficiently.About the PositionFormation Bio is seeking a motivated, experienced Director , Formulation Development to join our dynamic team. This critical role ... will report to the VP, CMC and will be responsible for leading formulation development...of formulations for injection. Cross-Functional Collaboration: Partner with other CMC groups (analytical development, supply chain, etc) quality assurance,… more
- Formation Bio (New York, NY)
- …where you will work closely with our business development, legal, clinical, CMC , and data/engineering teams to on-board products with strong IP potential, and ... Comfortable working cross functionally, including partnering with clinical and CMC teams to identify patentable innovations during development, collaborating with… more
- Formation Bio (New York, NY)
- …faster and more efficiently.About the PositionFormation Bio is seeking an Associate Director , Program Management - Asset Diligence & Integration to partner with our ... from initial evaluation to pre-close. Coordinate cross-functional workstreams (Clinical, CMC , Regulatory, Nonclinical, QA, Commercial, Finance, Legal/IP). Maintain trackers,… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning ... plans for production, packaging, distribution, and clinical supply budgeting. The Director provides strategic leadership for Clinical Supply Chain & Logistics… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in ... NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GMP relevant activities involving but not limited to supplier qualification program, CMC audit, clinical/IMP vendor audits and overall GMP vendor audit program. ... Establish lessons learned from audits/inspections to drive continuous improvement in collaboration with other QA functions and/or applicable stakeholders. Support/ lead and or co lead due- diligence assessments of GMP facilities and or CMOs as deemed… more
- Novo Nordisk Inc. (Boulder, CO)
- …both worlds to develop new medicines for patients. The Position Oversee the CMC QA Organization for the site, which includes responsibility for the Quality Assurance ... (QA) function and serves as the leading expert in quality, compliance, and quality management systems (QMS). Provide direction & coordinate the Quality organization activities to support the business progress. Formulate, communicate and implement the QA… more
