- Merck & Co. (Rahway, NJ)
- …building and executing CMC development plans.Under the guidance of the CIPM Director & Portfolio Lead, the core responsibility of this individual will be to lead ... projects and products that improve human health and business.Under GPAM, the CMC Integrated Project Management (CIPM) organization was formed to enhance our Project… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ( CMC ) ... and regulatory leaders.Responsibilities Strategic Leadership Develop and execute comprehensive CMC strategies for pre-clinical, clinical, and commercial-stage biologic products,… more
- Merck & Co. (Rahway, NJ)
- …process comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA: Experience supporting/writing regulatory filings (IND, MAA, ... (FDA, EMA, JNDA, TGA).-Leadership:-Establish and manage Cell Banking working groups, support CMC teams, and align resources to deliver on priorities. Manage and… more
- Merck & Co. (Durham, NC)
- …Global Science and Technology (GSEC) organization is seeking a highly motivated Director to lead our Pneumococcal Franchises (PCV) - Development and Commercial Team ... their product lifecycle-from development through commercialization and sustained supply. The Director will lead a team of specialists and collaborate across multiple… more
- Insmed Incorporated (San Diego, CA)
- …Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the regulatory leader on ... senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC , QA/QC, Nonclinical, Program Management, and external consultants to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Manufacturing Execution System as part of the Global MSAT team based ... in Raritan, NJ. Role OverviewThe Director of Manufacturing Execution System (MES) will be part...will work collaboratively with Operations, IT QA, Validation, Reg CMC to deliver on-time, on-budget and right-first-time MES solutions… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... Commercial Manufacturing groups. The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in managing work with external… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …alongside some of the brightest minds in biopharma. **Position Summary** The Scientific Director /Senior Director , CMC Team Leader is responsible for ... and Integration team is dedicated to developing and executing CMC strategies for small molecule and biologics portfolio utilizing...into medicines. **This role may be appointed at the Director or Senior Director level. Candidates with… more
- Lilly (Indianapolis, IN)
- …will remain a P2 in the new role. **Position Summary:** The Associate Director , CMC Project Management will provide strategic and operational leadership for ... investment strategy optimization at both project and portfolio level. The Associate Director , CMC Project Management may also partner with the Senior Director… more
- Lilly (Indianapolis, IN)
- …support communities through philanthropy and volunteerism. **Position Summary:** The Senior Director , CMC Project Management will provide strategic and ... operational leadership for cross-functional CMC team(s) and will partner with CMC ...cross-functional CMC team(s) and will partner with CMC scientific and technical leaders with accountability for technical… more
