- 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
- Jazz Pharmaceuticals (Philadelphia, PA)
- …Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in ... Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed… 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)
- …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
- 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)
- 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
- 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
- Insmed Incorporated (NJ)
- …substance synthesis, management of impurities and degradation products, formulation, manufacturing process , and device combination product development at various ... manage regulatory submissions for compounds in various phases of clinical development , marketing applications, and post-approval lifecycle activities by working with… more
- Merck & Co. (Rahway, NJ)
- …scientific methodology, we collaborate to discover the next medical breakthrough.The Biologics Analytical Research & Development department of our Company's ... of biology, chemistry, and lab informatics disciplines to enable development of biologics pipeline.We are looking for...standards of control strategy for residual HCPs and other process related impurities in biologics .A strong team… more
- Merck & Co. (Rahway, NJ)
- …Strong expertise in interpretation of characterization data in context of broader process and product development , critical reagents characterization and overall ... Job DescriptionThe Analytical Research & Development department of our Company Research Laboratories Division is seeking applicants for a Principal Scientist… more
- Curia (Boston, MA)
- … programs. In addition, the individual will collaborate closely with internal process development , manufacturing, and quality groups as well as clients ... DIRECTOR , ANALYTICAL DEVELOPMENT in Hopkinton, MA...Build collaborative relationships with key internal team members, stakeholders ( Process Development , Manufacturing, and Quality) and external… more
- Endo International (Horsham, PA)
- …we serve live their best life. **Job Description Summary** The Associate Director , Manufacturing Operations will provide leadership and management of operations at ... including Upstream Processing, Downstream Processing, and Manufacturing Support. The Associate Director is a member of the site leadership team and works… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance of ... drug products during formulation development and the drug product life cycle, including interpretation of relevant dissolution data. The scope includes small… more
- BeOne Medicines (San Mateo, CA)
- …both small molecules and biologics + Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including ... and registration strategies within the US and Canada. The Director will also provide line management, people development... Director will also provide line management, people development , and performance management as well as support/lead … more
- Battelle Memorial Institute (Columbus, OH)
- …analysis methods to improve the quality of results and/or the efficiency of the process . + Supports business development efforts led by others. + May assist ... Battelle delivers when others can't. We conduct research and development , manage national laboratories, design and manufacture products and deliver critical services… more
- Merck (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
