- Repligen (Waltham, MA)
- …of 10 years of experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.Minimum 5-8 years of experience mentoring and ... OverviewWe are seeking an experienced Director of Quality candidate to lead...release including deviation support, root cause analysis, customer complaint management , hosting customer/regulatory audits and Certificate of Quality… more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) ... and design controls for the assigned projects while adhering to management -approved strategic plans, corporate policies, and providing clear communication to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operations management , tech transfer, process and equipment validation or quality management ; with a preference for Cell/Gene Therapy experienceMinimum of ... 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,… more
- Merck & Co. (Rahway, NJ)
- …and fusion proteins. Within Mixed Modality, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Eisai, Inc (Nutley, NJ)
- …(CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice ... is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director...to evolving technologies. May be responsible for direct people management including goal setting, performance management , development,… more
- Merck & Co. (Durham, NC)
- …across a wide range of business activities.- Reporting directly to the Director , Supply Chain Management , the successful candidate's primary responsibilities ... the Supply Chain Logistics Strategy Leader will be responsible for the development, management , and growth of our warehousing and logistics operations, both on the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position Position provides field coaching, mentorship and management to the field-based Medical Liaisons, and develops and implements strategies:… more
- Merck & Co. (Rahway, NJ)
- …proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical ... Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a key leadership...testing, and process validation, with a strong understanding of quality management systems and regulatory compliance.Exceptional project… more
- Merck & Co. (San Francisco, CA)
- Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable insights to guide the business. Relationships Reports to the Director , Commercial Insights & Analytics. Internal relationships include close interactions ... staff that will assist in the project execution and management of specific research projects. May supervise junior market...channels Leadership And Development Capable of assuming role of Director CI&A when needed, such as representation on CI&A… 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 ... acceptability and identification of potential risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic ... has deep experience in procurement, strategic sourcing, and vendor management within the biotech, pharmaceutical, or life sciences industry.Responsibilities Develop… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Insmed Incorporated (San Diego, CA)
- …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 ... trend analysis are also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating technology… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and ... program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within… 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...implement procurement strategies and operations, contract negotiations, supplier relationship management , procurement systems functionality/workflows and assurance of compliance with… more
- Merck & Co. (Rahway, NJ)
- …formulation and process development through process tech transfer, scale-up activities, quality investigations, change management , and authoring GMP standard ... product aseptic processing, equipment, and sterile technique.Experience in leading quality investigations and change management .Familiarity with United States… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance, and R&D. The Director will serve as the ... Sr. Director , Manufacturing Execution System (MES) (Hybrid in South...our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of a HEDS Executive Director , the Senior Principal Scientist, Health Economics leads a team of health economists and outcomes ... economists and outcomes researchers.Accountable for team prioritization and development of high- quality health economic models and tools to support market access,… more
- Lundbeck (TX)
- …brain disease. Join us on our journey of discovery! POSITION SUMMARY: The Director , Chemical Biology leads a world-class team researching new understandings of the ... oversees their progression to early milestones Leads the design and synthesis of high- quality small molecule tools and early hits Working closely with project teams,… more
