- 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. (Rahway, NJ)
- …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
- 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
- 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
- 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
- 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …culture, purification, and formulation + Proven track record in process development , scale-up, and technology transfer of biologics products + Strong ... **Position Overview:** The Senior Director , MSAT Biologics provides strategic and...knowledge of cGMP regulations and ICH guidelines relevant to biologics manufacturing + Experience with PAT ( Process … more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …drug development process , preferably with experience in early phase development covering both biologics and small molecule - Experience in managing and ... **Senior Director , Early Development Team Lead** **Role...- Working knowledge of all functional areas of exploratory development , including, CMC (small molecules and biologics ),… more
- Merck (Rahway, NJ)
- …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
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …relevant experience in the biopharmaceutical industry with a strong focus on biologics downstream process development , scale-up, technology transfer, and/or ... **Job Summary** **** The Associate Director , MSAT - Downstream provides specialized technical leadership...Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory, Process Development , Analytical Development , and… more
- Boehringer Ingelheim (NJ)
- **Description** In the role of Director of Business Development & Key Account Management (BD&KAM) you will primarily execute on the contract manufacturing ... an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our… more
- Merck (Rahway, NJ)
- **Job Description** **Raw Materials & Medical Device Director , Small Molecule Analytical Research & Development ** The Small Molecule Analytical Research and ... during internal and external compliance audits + Ensuring operational excellence and drive process improvements + Staff development and talent recruiting + Work… more
