- Merck & Co. (Rahway, NJ)
- …the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools,… more
- Eli Lilly and Company (Indianapolis, IN)
- …technical knowledge and experience of small molecule drug product development , commercialization and manufacturing processes. Prior regulatory CMC experience ... guidelines for reporting post approval changes and updating global product registrations. Develop and evaluate global CMC ...leadership role in the critical review of molecule specific CMC development strategies and submission content for… more
- 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)
- …pr ogram (s) . The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie ... clinical development , CMC , supply chain, & human health),...supporting all protocol and program cost estimates requested by Product Development Teams . - Responsible for… 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
- 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
- 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)
- …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
- Vera Therapeutics (Brisbane, CA)
- Job Description Title: Executive Director , Translational Research Biology Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage ... in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as… more
