- Merck & Co. (Rahway, NJ)
- …and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, ... and fusion proteins. Within Mixed Modality, the large molecule product development Director will influence the strategy,...scale, step across boundaries and implement novel innovations during drug product development to enable best science… more
- Formation Bio (New York, NY)
- …Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ( CMC ) activities related to biologic product development at Formation Bio. This ... is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more… more
- Merck & Co. (Rahway, NJ)
- …and accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - Works directly in the SAP ... & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs...s used within the assigned program(s) ( ie Bulk Drug Product ).- - Oversees all bulk … more
- Merck & Co. (Rahway, NJ)
- …an experienced leader who will manage a team of scientists to support drug substance process development activities to enable and accelerate early and late-stage ... pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research and… 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
- ACROBiosystems Inc. (Boston, MA)
- … development and clinical applications from target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical ... of therapeutic development. Our mission is to accelerate the process of target therapeutic drug development. We aim to be a cornerstone company in the life science… more
- Organon (Plymouth Meeting, PA)
- Job Description The Position The Principal Scientist ( Director ) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) aspects ... and incorporating knowledge of the changing regulatory environment. Embed regulatory CMC activities within product development plans that outline the… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …and their teams in the field of analytical controls and compliance Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... c) Reference Standard Management; d) GMP Quality Systems Contribute to product development from Research to Commercialization by collaborating with multiple… more
- Eli Lilly and Company (Indianapolis, IN)
- …are currently available within the Bioproduct Research and Development (BR&D) drug product organization. This group is a multidisciplinary organization, ... AOC). These newer treatment modalities have resulted in the drug product team investing in new formulation...in clinical trial manufacturing. Lead the preparation of the CMC portion of the IND/CTA/BLA/NDA. Build process capabilities for… more
- BioSpace (Cambridge, MA)
- Job Details The Role Moderna is seeking a Associate Director Publication Writer to lead end-to-end publication management activities across multiple therapeutic ... authors, as well as cross-functional teams including Medical, Research, Development, CMC , Health Outcomes, and external vendors, to lead writing activities for… more
- BioSpace (Waltham, MA)
- …current planning activities and shaping future supply chain capabilities. The Director collaborates cross-functionally with Process Development, Research, CMC , ... and follow us on X , LinkedIn and Facebook . Role Summary: The Director of Supply Chain Planning is responsible for end-to-end inventory and production planning… 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...and integrates drug substance, drug product , and device inputs to CMC team… more
- Lilly (Indianapolis, IN)
- …+ Demonstrated deep technical knowledge and experience of small molecule drug product development, commercialization and manufacturing processes. + Prior ... who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs -...guidelines for reporting post approval changes and updating global product registrations. + Develop and evaluate global CMC… 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) ... strategy to effectively advance to next key milestone and to deliver a differentiated product . Serves as the spokesperson for all CMC functions and ensures… more
- Lilly (Indianapolis, IN)
- …knowledge in drug development including API, or Drug Product or Analytical + Demonstrated CMC regulatory experience **Additional Information** + ... better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC ...Assures recruiting of people with sound technical capabilities in Drug Substance/ Drug product /Analytical related sciences.… more
- Lilly (Indianapolis, IN)
- …assigned product (s). Key responsibilities: + Deep technical knowledge of synthetic molecule CMC drug development science(s). + Knowledge of global CMC ... who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC ...regulatory initiatives desirable. + Relevant experience in synthetic molecule drug substance and/or drug product … more
- Takeda Pharmaceuticals (Boston, MA)
- …pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead with late-stage development, marketing application experience ... therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you...served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international… more
- Takeda Pharmaceuticals (Lexington, MA)
- … CMC investigational and/or registration strategies for assigned products as GRA CMC Product Lead and/or team lead. Assigned products include genetically ... executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy....of scientific principles and profound grasp of global regulatory CMC requirements relevant to global drug development… 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 ... unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of...position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by… 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 ... documentation leading to successful preparation and approval of Investigational New Drug applications (INDs), Investigational Medicinal Product Dossiers (IMPDs),… more
