- 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. (North Wales, PA)
- …projects - Participation in continuous improvement projects that require extensive product development experience and comprehension of our company procedures ... Managers in Value & Implementation (which is this job), Development , and CMC ; Discovery Portfolio Managers; Alliance...expertise in pharma and/or biotech or related role in product development /pharma/ biotech; - Demonstrated ability to… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Director , Global Sourcing (Direct Materials) as part of the Technical Operations team ... based in Raritan, NJ.Role OverviewThe Director , Global Sourcing (Direct Materials) is responsible for leading the design and execution of a high-performing Global… 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 ... Leadership, Pharmaceutical Guidelines, Problem Solving, Process Analytical Technology (PAT), Product Development , Professional Networking, Quality Standards, Regulatory… more
- ACROBiosystems Inc. (San Diego, CA)
- …from target discovery and validation, candidate drug screening and optimization, CMC development , preclinical and clinical studies, commercial production, and ... providing quality products and services and accelerating the process of therapeutic development . Our mission is to accelerate the process of target therapeutic drug… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …& meetings with relevant domestic and international stakeholders within Novo Nordisk CMC & Product Supply. Ensure corporate level investment requirements & ... a global supply of our hemophilia and growth hormone product lines, as well as our next generation of...Provide PPM support, in conjunction with Finance, to the development of the M2-US Investment Budget Lead the overall… 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
- 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
- Lilly (Indianapolis, IN)
- … Project Management is the program and project management arm of our critical Product Research and Development group. CMC Project Managers are responsible ... teams and therapeutic areas to translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional CMC 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
