- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product ...Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities,… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project ... Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a...of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all… more
- Merck & Co. (Rahway, NJ)
- …products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position ... controls approach within Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations...within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Merck & Co. (Rahway, NJ)
- …matters.Review process change requests and deviation reports while ensuring regulatory compliance .Education and Minimum Requirements:Bachelor's degree in ... Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance , Root Cause Analysis (RCA), Stakeholder… 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. (North Wales, PA)
- …assessment of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise ... role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the… 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 ... and vaccine development, with a proven track record of successful product launches and market penetration. This role requires exceptional marketing acumen… more
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... ogram (s) . The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical… more
- Insmed Incorporated (San Diego, CA)
- …transfers and mentoring junior staff. Maintaining laboratory equipment, ensuring safety and regulatory compliance , and supporting audits are also part of the ... on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of the… more
- Merck & Co. (Rahway, NJ)
- …change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and ... Engineering, Chemistry, Clinical Operations, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance ,… more
- Merck & Co. (Rahway, NJ)
- …and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and ... Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our… more
- Repligen (Waltham, MA)
- …, Quality - Quality Network Leader, Chromatography & Proteins.ResponsibilitiesThe Director , Quality will be responsible for:Maintaining site compliance ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,...quality assurance team which includes all day-to-day activities for product manufacture, test and release including deviation support, root… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... subsidiaries in their HTA submissions.The incumbent is expected to contribute to product development and marketing strategies throughout the lifecycle to ensure that… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Eisai, Inc (Exton, PA)
- …close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also ... Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of… 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 ... upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial… more
- Merck & Co. (Durham, NC)
- …Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… more
- Eisai, Inc (Nutley, NJ)
- …exchange.Maintain scientific credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant ... If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and… more
