- Merck & Co. (Upper Gwynedd, PA)
- …-Primary responsibilities include, but are not limited to:Regulatory Responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for ... the delivery of all regulatory milestones through product development including assessment of the probability of regulatory success together with risk mitigation… more
- Formation Bio (New York, NY)
- …all Chemistry, Manufacturing, and Controls ( CMC ) activities related to biologic product development at Formation Bio. This is a strategic and ... 10+ years of experience in the biopharmaceutical industry, with deep expertise in CMC development for biologics. Prior experience in a leadership role within… more
- Merck & Co. (Rahway, NJ)
- …Models, People Leadership, Pharmaceutical Development , Product Design, Product Development , Regulatory CMC , Stakeholder Management, Statistical ... commercial process definition. The individual stands at the vanguard of commercial product development , ensuring that our capabilities, talent, and operating… more
- Merck & Co. (Rahway, NJ)
- …of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our ... development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D)...Research and Development , Biologics Process Research and Development , CMC and Regulatory in aspects of… more
- Merck & Co. (Rahway, NJ)
- …late-stage pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics ... upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial… more
- Eisai, Inc (Exton, PA)
- …and other internal (PST) and external functions to support successful product development , including sharing expertise, ensuring optimum decision-making, ... as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations… more
- ACROBiosystems Inc. (Boston, MA)
- …from target discovery and validation, candidate drug screening and optimization, CMC development , preclinical and clinical studies, commercial production, and ... customers.Communicate technical information effectively to customers.Work closely with Marketing, Product Development , Technical Support, and other internal… more
- Legend Biotech US (Somerset, NJ)
- …and ensuring timely and effective delivery. The position demands strong leadership in product development and team management, particularly in cell therapy and ... with the project management office to evolve company processes for product development Establish a collaborative, science-based, agile, innovative, continuous… more
- Ionis (Carlsbad, CA)
- …culture while you develop and expand your career! SR. SCIENTIST /ASSISTANT DIRECTOR , ANALYTICAL DEVELOPMENT & QUALITY CONTROL Seeking an experienced analytical ... our AD/QC group at the Sr. Scientist or Assistant Director level. The ideal candidate will be a self-starter,...GC for the analysis of drug substance and drug product samples Good understanding of the drug development… more
- Bausch Health (Bridgewater, NJ)
- …discipline throughout the product /dossier management lifecycle, including Development , Promotion and Advertising, Labeling, CMC , Commercialization, and ... and post-approval/regulatory compliance for assigned products. Participates on the product development /life-cycle management team to provide regulatory guidance… 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...requirements, budget and resources. + Multiple product development experiences of leading a CMC team… more
- AbbVie (North Chicago, IL)
- …5-10 years of working experience required in the same/similar role or in related CMC function. + Multiple product development experiences of leading a ... participates in communications and meetings with regulatory agencies. Accountable for creating CMC development plan incl. timelines, risks and mitigations in… more
- Lilly (Indianapolis, IN)
- …a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval ... Demonstrated deep technical knowledge and experience of small molecule drug product development , commercialization and manufacturing processes. + Prior… more
- Lilly (Indianapolis, IN)
- …scientific 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 ...Ensures appropriate definition and approves regulatory strategies for global CMC development and manufacturing changes. + Maintains… more
- Takeda Pharmaceuticals (Boston, MA)
- …Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...experience including experience as an RA CMC product lead with late stage development , international… more
- Lilly (Indianapolis, IN)
- …strategy based upon global regulatory changes. + Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development ... + Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content. + Makes decisions on CMC… more
- AbbVie (North Chicago, IL)
- …& Development (R&D) organizations. Represents CMC on teams such as product development , Global Regulatory Product Teams and Operations brand teams to ... requests. + Represents CMC regulatory affairs on teams such as the product development , Global Regulatory Product Teams and Operations brand teams,… 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 ... Accountabilities: + Develops, executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy. + Combines extensive… 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 ... multiple products. + Lead the execution and influence the development of global CMC regulatory strategies, including...risk mitigation strategies to ensure right first-time approvals of product submissions. + Lead the execution of these global… more
- Bristol Myers Squibb (Indianapolis, IN)
- …analytical) strategies for CMC activities (drug substance, API, drug product , and analytics) for compounds in Development (radiopharmaceuticals). The ... be the global leader in radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC )...following. Other duties may be assigned. + Member of CMC Development Teams providing Quality (QA) input… more
