- Bristol-Myers Squibb Company (Indianapolis, IN)
- …develops and drives Quality (manufacturing and analytical) strategies for CMC activities ( drug substance, API, drug product , and analytics) for compounds ... specific analytical method life cycle documents (eg, API and bulk drug product specifications, analytical test methods (including micro), and… more
- 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
- 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. (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
- Eli Lilly and Company (Indianapolis, IN)
- …substance manufacturing for both clinical and commercial settings. Collaborate across internal CMC networks ( Drug Product Delivery, Project Management, ... Development (SMDD) is responsible for the development of synthetic drug substances and drug products from the...and formulation. The position presents an opportunity to lead CMC activities to support clinical trials, product … more
- Program for Appropriate Technology in Health (Seattle, WA)
- …advisor(s) and project team lead, work to develop, execute, and deliver the CMC strategy in integrated product development and lifecycle management plans ... Center for Vaccine Innovation and Access (CVIA) Chemistry and Manufacturing Controls ( CMC ) programs. The Medical Devices and Health Technologies (MDHT) program at… more
- ADMA BIOMANUFACTURING LLC (Boca Raton, FL)
- …Biologics. We currently have an exciting opportunity available for an Associate Director , Regulatory Affairs - Plasma Services in Boca Raton, Florida! The Associate ... Director , Regulatory Affairs - Plasma Services is responsible for...regulatory documents for submission to the US Food and Drug Administration (FDA). This position provides advice and direction… 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
- 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
- BeOne Medicines (Emeryville, CA)
- …15 years of relevant pharmaceutical or biopharmaceutical industry experience in innovative drug CMC development, manufacturing, Quality, etc. including minimum 8 ... * Lead or/and oversee regulatory risk assessment, identify key biologics regulatory CMC issues and mitigation activities needed throughout product lifecycle.… more
