- Insmed Incorporated (San Diego, CA)
- …us expand what's possible for patients with serious diseases. Reporting to the Associate Director , Quality Control , you'll be involved in transfer of method ... from Analytical Development into QC. The Quality Control Senior Research Associate will author and execute phase appropriate qualification/validation protocols… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director , Regulatory Affairs, supports products in the Oncology therapeutic area as part of a regulatory team.- The individual will have ... in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other functional areas (eg, clinical research,… more
- Merck & Co. (Rahway, NJ)
- …DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD) Team ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… more
- Insmed Incorporated (NJ)
- …vendor management experience.Proven expertise in root cause analysis, investigations, change control , and Quality risk management.Direct experience with clinical ... and for the future of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and combination… more
- Repligen (Waltham, MA)
- …drives progress. Join us!About the RoleRepligen is seeking a hands-on, strategic Director of IT & OT Infrastructure to lead the design, implementation, and ... strategy, while overseeing internal teams, MSPs, and vendors to ensure high- quality , secure, and reliable services.You will lead and develop a high-performing… more
- Merck & Co. (Rahway, NJ)
- …network and partners in commercialization and manufacturing in aspects of quality control , compliance, and strategic partnering. Primary Responsibilities: ... Guidelines, Pharmaceutical Microbiology, Process Analytical Technology (PAT), Professional Networking, Quality Control Management {+ 5 more}Preferred Skills:… more
- Formation Bio (New York, NY)
- …vendor relationships and governance, holding external partners to high standards of quality , cost control , and on-time deliverables. Serve as the Operations ... new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Associate Director , Patient Services Partner Relations oversees key vendor partnerships that support ... service excellence, compliance, and alignment with Insmed's strategic goals.The Associate Director , Patient Services Partner Relations is responsible for leading and… more
- Cipla (Central Islip, NY)
- Job Title: Director - Procurement, Cipla North America Reports to: Head SCM, Cipla North America Job Purpose The Director of Procurement is responsible for ... agreements to secure favorable terms and ensure the on-time delivery of high- quality products and services. Monitor supplier performance and resolve any issues or… 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...organization to ensure continuity of supply while optimizing cost, quality and delivery for internal and external stakeholder satisfactionCollaborates… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control , risk management, material and molding, design validation to create and ... Engineering, Manufacturing Processes, Mechanical Engineering, Mechanical Testing, Medical Device Quality Systems, Microscopies, Negotiation, Optical Microscopy, Product Commercialization, Production… more
- Insmed Incorporated (NJ)
- …with regulatory requirements while maintaining operational excellence. The Executive Director , Cybersecurity & Risk Management plays a critical leadership role ... Committee and Board of Directors.Establish and maintain governance frameworks and control structures consistent with NIST and FDA data protection standards.Partner… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Novo Nordisk Inc. (Boulder, CO)
- …to our patients Work effectively across all departments, such as Quality Assurance/ Control , Chemical Development, Program Management, Regulatory, Analytical ... us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …methodologies, tools, and core deliverables. Relationships Reports to the Director , Sales Reporting & Forecasting. Position regularly interacts with members ... budget, per direction, and are internally consistent with group deliverable quality Systems and Data Management Responsible for gross-to-net forecast models, tools… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …demonstrated passion for creating new medicines.Experience with Engineering, Operations, Quality Control and Facilities Management.Experience in effectively ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , Engineering as part of the Technical Operations team based in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily ... maintenance of signal tool and support tasks of change control , training material update, and end user support or...as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool… 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 ... programs.What You'll Do: Accountable for reviewing and approving all CMC change control documents and disposition of proposed changes and scheduling submissions as… more
- Repligen (Rancho Dominguez, CA)
- …for appropriate quality requirements.Preparing appropriate documentation for critical quality control points throughout the manufacturing processes. Ensures ... our Rancho Dominguez, CA site and will report to the Sr. Director of Quality .ResponsibilitiesUse/application of investigative tools to perform investigations and… more
- WuXi AppTec (Middletown, DE)
- …leader to establish and oversee all QC operations for WuXi STA's new DE site. The QC Director will lead all Quality Control functions for WuXi STA's new drug ... will oversee lab buildout, equipment qualification, method transfers, staff recruitment, and quality system implementation. In steady-state, the QC Director will… more
