- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- Eisai, Inc (Exton, PA)
- …as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a… more
- Merck & Co. (Upper Gwynedd, PA)
- …, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is responsible ... CMC - Associate Principal Scientist, CMC...guidances, and is-responsible for the preparation and submission of CMC dossiers for all assigned development products. -Primary responsibilities… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ( CMC ) ... and regulatory leaders.Responsibilities Strategic Leadership Develop and execute comprehensive CMC strategies for pre-clinical, clinical, and commercial-stage biologic products,… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... / our Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of portfolio, initiatives for… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... and packaging activities as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical supply chain metrics and/or… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... Commercial Manufacturing groups. The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in managing work with external… more
- AbbVie (Irvine, CA)
- …. Job Description Further develop your expertise and join our team as Director , CMC Product Development. Must have Medical Device experience. The Product ... Development Director (PDD) will be a member of the Operations...for pipeline programs from a Chemistry, Manufacturing, and Controls ( CMC ) perspective. They will lead the Product Presentation and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible ... portfolio. This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global… more
- UTMB Health (Huntsville, TX)
- Director Pharmacy Service - CMC Huntsville Central Pharmacy **Huntsville, Texas, United States** **New** Business, Managerial & Finance UTMB Health Requisition # ... problem-solving skills. **_SUPERVISION:_** + Received:Associate Vice President Pharmacy Services, CMC + Given:Assistant Director , Pharmacy Staff **_BUDGET… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee the development ... Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and manage regulatory… more
- Bristol Myers Squibb (Indianapolis, IN)
- …leader in radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in Indianapolis.… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of ... beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has… more
- AbbVie (North Chicago, IL)
- …high complexity utilizing a matrix approach. Leads Chemistry, Manufacturing and Controls ( CMC ) teams and Product Presentation and Device Strategy Teams (PPDST) of ... key member of AST, has accountability for creating a CMC strategy and development plan that aligns with overarching...a differentiated product. Serves as the spokesperson for all CMC functions and ensures information flow among AST and… more
- WuXi AppTec (Boston, MA)
- …of 5 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing. + Working knowledge and understanding of ... problems **Leadership Activities:** + Work closely with team members across all CMC -related business units and with the STA management team to ensure coordination… more
- Danaher Corporation (Fargo, ND)
- …and improve human health. We are seeking a strategic and technically accomplished Director of Drug Product CMC to lead client-facing drug product development ... is critical in driving the design, development, and execution of robust CMC strategies for a diverse portfolio of clients, spanning early-phase to commercial-stage… more
- UTMB Health (Stafford, TX)
- …treatment algorithms and practices. Works under the general direction of the UTMB - CMC , CHS medical director , with extensive latitude for the exercise of ... Staff Psychiatrist, CHS- CMC - CASUAL **Stafford, Texas, United States** Physician UTMB Health Requisition # 2503005 The mission of Correctional Managed Care is to… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics....the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD … more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist ( Director ) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) ... internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and initial product… more
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