- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC ... based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage… more
- GE Aerospace (Evendale, OH)
- **Job Description Summary** The Lead Ceramic Matrix Composite ( CMC ) Development Lab Engineer provides direction and assistance to the work group to achieve ... role, you will work both independently and with various teams to develop CMC components for aircraft engines and other aerospace applications. **Job Description** A… more
- Editas Medicine (Cambridge, MA)
- …regulatory success, and proposing risk mitigation measures. + Serve as a Regulatory CMC lead on relevant cross-functional or functional teams to provide ... with applicable EMA/FDA/ICH/WHO/Global regulations and regulatory guidance and guidelines. + Lead CMC related interactions with the health authorities including… more
- Merck (North Wales, PA)
- …Director responsibilities include but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory ... CMC guidelines regarding IND/BLAs or post approval changes. + The CMC Project Lead is accountable for the delivery of all regulatory milestones for higher… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC ... CMC experience including experience as an RA CMC product lead , or equivalent industry experience, with international experience strongly preferred.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …report directly to Head of CMC Regulatory Affairs at Gilead. **JOB DESCRIPTION** + Lead CMC teams/ groups to support the CMC product and portfolio ... collaborative relationships with local & global internal/ external partners. + Lead CMC strategies, assess risks, and develop contingency plans, including major,… more
- Lilly (Indianapolis, IN)
- …for marketed product support. Responsibilities:: **Regulatory & Drug Development Expertise** + Lead CMC submission management process by providing knowledge of ... better for people around the world. Organization Overview: The Global CMC Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery Excellence (RDE)… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …in non-clinical IND-enabling studies and ensure these studies are adequately supported by CMC data packages. + Lead /support internal and external stakeholders to ... employees. Job Description We have an exciting opportunity for a Senior CMC Manager in theOffice of Technology Development (OTD).At Memorial Sloan Kettering's (MSK),… more
- GE Aerospace (Evendale, OH)
- **Job Description Summary** This role is within the Ceramic Matrix Composite ( CMC ) Mechanical Design team in GE Aerospace's Engineering Division. This individual ... will be responsible for the design and development of CMC components within the Combustor Module of the RISE...between GE Aerospace and Safran Aircraft Engines. As a Lead Engineer, you will play a key role in… more
- Sanofi Group (Framingham, MA)
- …manner, in order to build a trusting relationship with business stakeholders. + Lead a team of internal and external resources assigned to perform lab equipment ... Work closely with iCMC Data Integration & Governance Technical Lead and Digital Architecture to help decision making regarding...truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those… more
- GE Aerospace (Evendale, OH)
- …Description Summary** This role is within the Commercial Ceramic Matrix Composite ( CMC ) Mechanical Design team in GE Aerospace's Engineering Division. The team is ... responsible for the design and development of CMC components within the High-Pressure-Turbine (HPT) and Combustor Module...As the Staff Engineer, you will serve as the lead for projects focused on durability maturation, production support,… more
- Takeda Pharmaceuticals (Boston, MA)
- …which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization + Lead regulatory ... for conformance with established requirements + Represent Takeda RAV CMC in Health Authority meetings and lead ...RAV CMC in Health Authority meetings and lead or supports CMC preparation activities for… more
- GE Aerospace (Evendale, OH)
- …Description Summary** This role is within the Commercial Ceramic Matrix Composite ( CMC ) Mechanical Design team in GE Aerospace's Engineering Division. The team is ... responsible for the design and development of CMC components within the High-Pressure-Turbine (HPT) and Combustor Module...GE9X and LEAP Commercial Turbofan engines. As the Advanced Lead Engineer, you will play a key role in… more
- Organon & Co. (Plymouth Meeting, PA)
- …regulations and guidance's, and Company procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle ... initiatives, on an as-needed basis. **Responsibilities** + Serve as the CMC Product Lead for assigned products and be accountable for the delivery of… more
- AbbVie (Irvine, CA)
- …lead position based in Irvine, CA reporting to the Director, S&T Toxins. + Lead CMC analytical development with in-depth knowledge of a broad range of ... and maintain strong working relationships with internal, global, and external collaborators. + Lead CMC analytical development with in-depth knowledge of a broad… more
- CSL Behring (King Of Prussia, PA)
- …(eg Health Authorities, Industry Associations) and company partners to shape regulatory CMC requirements. You will lead and direct strategy for regulatory ... rare conditions. Could you be our next CSL Plasma Lead for Global Regulatory Affairs, Plasma? This position is...You will report to the VP, Head of GRA CMC . You will provide strategic leadership and oversight in… more
- Lilly (Indianapolis, IN)
- …purification, isolation, and formulation. The position presents an opportunity to lead CMC activities to support clinical trials, product commercialization, ... a creative and energetic chemist with experience in chemistry, manufacturing and control ( CMC ) of oligonucleotides to participate in a wide range of activities. The… more
- Sanofi Group (Framingham, MA)
- … a cross-functional team in a matrix organization; Experience in strategic CMC /development project lead roles; Global exposure and stakeholder management ... leverage Science and Technology for performance of the manufacturing network. + Lead talent development and ensure performance mindset shift for the techno platform.… more
- Taiho Oncology (Pleasanton, CA)
- Director, Regulatory Affairs CMC Pleasanton, CA, USA Req #355 Tuesday, March 26, 2024 Looking for a chance to make a meaningful difference in the oncology space? ... oncology company in the role of Director , Regulatory CMC , reporting directly to Executive Director, Regulatory ...well in a team environment and the ability to lead others. + Working knowledge of project management. The… more
- BeiGene (San Mateo, CA)
- …on programs from a pre-clinical stage through clinical proof of concept. + Lead cross-functional team to author CMC / quality sections of regulatory submissions ... We are seeking an exceptional and highly motivated CMC leader to join the BeiGene Cell Therapy...therapy development. Ideal candidate must be proficient in both CMC strategic planning, execution, and matrix team management. The… more