- Merck & Co. (Rahway, NJ)
- …early and late-stage pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within ... manage a team of scientists to support drug substance process development activities to enable and accelerate...the Biologics Process Research and Development (BPR&D) organization is responsible for designing and implementing… more
- Merck & Co. (Upper Gwynedd, PA)
- …marketed Oncology medicines. Our Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the ... in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and Assist the Executive Director /AVP in… more
- Merck & Co. (Rahway, NJ)
- …Our Research and Development Division's microbiology team is seeking a Director for the Rahway NJ GMP microbiology operations.- The primary objective of the ... formulations, and their processes for non-sterile and sterile products. The Director will also collaborate with Development Quality, Pharmaceutical Operations,… more
- Merck & Co. (Rahway, NJ)
- …Required Experience and Skills: Experience with small molecule drug substance and/or biologics process development and scale-up, moving from laboratory ... of new manufacturing technology/processes, training opportunities for improved manufacturing process development , and seamless technology transfer to commercial… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRaw Materials & Medical Device Director , Small Molecule Analytical Research & Development The Small Molecule Analytical Research and ... during internal and external compliance auditsEnsuring operational excellence and drive process improvementsStaff development and talent recruitingWork with the… more
- Formation Bio (New York, NY)
- …harnessing the power of deep learning and artificial intelligence to break clinical development paradigms and transform how drugs and biologics are developed. We ... to include management of other attorneys.Essential Experience: Deep expertise in pharma/ biologics IP lifecycle management, from early development through… more
- Merck & Co. (Rahway, NJ)
- …in the biopharma industry with good understanding of the drug discovery and development process and broad knowledge of the biotech and healthcare sector. ... cultivates external partnerships that grow our portfolio in meaningful ways. - The Director , Business Development & Licensing - Enabling Technologies Search and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business process owners to integrate quality into all stages of process development , ensuring stakeholders are educated on common deviations.Ensure proper ... process owners to monitor the effectiveness of clinical development processes through KQIs, demonstrating process control...; Must have a strong understanding of pharmaceutical drug development . A background in biologics would be… more
- Insmed Incorporated (NJ)
- …activities to ensure phase-appropriate compliance.Actively represent QA in technical development activities, including process development , method ... related to clinical manufacturing.Drive Quality input into lifecycle changes, process optimizations, and continuous improvement initiatives across development … more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC post approval ... post-approval changes. This role will also lead CMC regulatory strategy development and implementation in coordination with different regions that incorporates risk… more
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