- J&J Family of Companies (Raritan, NJ)
- …We are searching for the best talent for a **Technical Fellow ( Director ), Advanced Therapies - MSAT** to be in Raritan, NJ, Titusville, NJ, ... Fellow curates and analyzes manufacturing case studies to expedite the release of drug products. This role requires deep expertise in key areas, including apheresis… more
- WSP USA (Jersey City, NJ)
- …a dynamic and knowledgeable **Health, Safety, and Environment (HSE) Director ** to lead the development, implementation, monitoring, and continuous improvement ... will be a key resource for interpreting health, safety, and environmental regulatory requirements, assuring compliance and best practices. As an integral part of… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …skilled and experienced professional to join our organization as the Assoc. Director of Manufacturing Science and Technology (MSAT) for Upstream processes. This ... and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. +… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Position Overview:** The Senior Director , MSAT Biologics provides strategic and technical leadership for all late-stage and commercial manufacturing processes for ... process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …experience strongly preferred. - Advanced analytic skills, and general understanding of the drug development and regulatory process. - Successful track record of ... **Job Summary** The Senior Director of Quality Strategy and Operations will be...data integrity policies, procedures, and guidelines. Ensure compliance with regulatory requirements (eg, FDA, EMA) and industry standards (eg,… more
- Merck (Rahway, NJ)
- …an experienced leader who will manage a team of scientists to support drug substance process development activities to enable and accelerate early and late-stage ... pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research and… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …to optimize omnichannel marketing campaigns. You will report to the Sr Director , Omnichannel Advanced Analytics Lead. This role is dynamic, fast-paced, highly ... managed, governed, and secured, following industry best practices and regulatory requirements. + Model Otsuka's core competencies (Accountability for Results,… more
- J&J Family of Companies (Titusville, NJ)
- …matrix interactions includes individuals from TA strategy, GCSO, global regulatory affairs, project management, finance, legal, quality assurance, quality monitoring ... & compliance, clinical supplies unit, drug discovery, early clinical development, strategic marketing, CM&C, preclinical department and other scientific and business… more
- Organon & Co. (Jersey City, NJ)
- …and distributed in accordance with Organon expectations and all applicable regulatory requirements. The External Systems Quality Leader (ESQL) serves a leadership ... of products to Organon's revenue, number and complexity of in-markets, regulatory history, historical performance (production and compliance), new product or market… more
- Merck (Rahway, NJ)
- **Job Description** **Join Our Team as a Biologics** ** Drug Substance & Cell Banking Leader** **!** Are you ready to take your career to the next level? We are ... seeking a dynamic and visionary Biologics Drug Substance & Cell Banking Leader to spearhead our...DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear… more