- Merck & Co. (Rahway, NJ)
- …Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , Regulatory Submissions, ... Job DescriptionAssociate Director , Business System Labeling Management Required experience and...and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or… more
- Merck & Co. (Upper Gwynedd, PA)
- …Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance with global regulations and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team ... based in Raritan, NJ. Role OverviewThe Director of Operations is an exempt level position working within Technical Operations . This individual will be… more
- Insmed Incorporated (San Diego, CA)
- …program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to ... for Millennials™, and Best Medium Workplaces™ lists.OverviewLead Analytical Development Operations function to build out the process development support testing… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Eisai, Inc (Exton, PA)
- …Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established and ... profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream...for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical ... Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical… more
- Merck & Co. (Durham, NC)
- …for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong ... excellence in Compliance, Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead, you will report into Director , Chemical Technical Operations , External Manufacturing API Technology, and play a pivotal role ... matters.Review process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the Oncology at Eisai. This Executive ... Director will lead franchise programs, and will be the...opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a highly skilled and experienced Director of Companion Animal Vaccine to lead our efforts in developing and managing our companion ... research and development of new vaccines, ensuring they meet regulatory requirements and industry standards.Collaborate with cross-functional teams, including R&D,… more
- Twist BioScience (South San Francisco, CA)
- …of MES professionals, primarily software developers, who work in concert with Manufacturing Operations , Quality Assurance, and R&D. The Director will serve as ... Sr. Director , Manufacturing Execution System (MES) (Hybrid in South...closely with the platform architecture and infrastructure teams, Manufacturing Operations , Quality Assurance, Process Development, and Regulatory … more
- Tris Pharma (Monmouth Junction, NJ)
- …in our Monmouth Junction, NJ facility for an experienced, hands-on SR. Director / Director , Procurement. Title and salary commensurate with experience. The ... Director / Senior Director , Procurement is responsible for...small team to develop and implement procurement strategies and operations , contract negotiations, supplier relationship management, procurement systems functionality/workflows… more
- Merck & Co. (Rahway, NJ)
- …Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain Operations .Current ... Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and communication… more
- Merck & Co. (Rahway, NJ)
- …as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies ... practices related to clinical supply planning and incorporate them into the team's operations . - Focus on Customers & Patients. - Make rapid, disciplined decisions.… more
- Merck & Co. (North Wales, PA)
- …with partners, vendors, and vendor management team . Review and provide clinical operations input into relevant clinical documents such as the protocol and other ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Formation Bio (New York, NY)
- …faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities ... development through commercialization. You will oversee internal and external teams, ensure regulatory compliance, and play a key role in scaling our biologics… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Director , HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle ... go-to-market/expansion strategy for Primary Care in AD. Collaborate with Sales Leadership, Operations , and SOC teams and leverage learnings from current PCP work to… 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 ... other teams within BPD and staff in Process Cell Science, US Operations , Clinical Manufacturing, and Commercial Manufacturing groups. The candidate should be capable… more
