- Formation Bio (New York, NY)
- …biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC ... manufacturing processes, formulation development, analytical methods, and global regulatory requirements. Proven ability to lead cross-functional teams and… more
- Merck & Co. (Rahway, NJ)
- …in DS manufacturing operations (cell culture and purification) Strong understanding of regulatory requirements and inspection readiness Ability to lead without ... Job Description Lead the Future of Biologics Drug Substance Commercialization!...Provide technical oversight for DS process development, characterization, and regulatory filings Ensure smooth execution of PPQs and BLAs… more
- Merck & Co. (Rahway, NJ)
- …cell bank and working cell bank) manufacturing operationsStrong understanding of regulatory requirementsAbility to lead without authority, build trust, and ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal ... device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key...Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …multiple large molecule programs across a variety of platformsExpert knowledge in global regulatory requirements for large molecule commercialization and BLA ... are developed by working teams supporting the product.Compile with our company's Global and regulatory requirements and execute current Good manufacturing… more
- Eisai, Inc (Nutley, NJ)
- …of staff. Determining timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and ... Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under...cycle management of existing products. May serve as the lead regulatory representative on the project team… more
- Merck & Co. (Rahway, NJ)
- …and other pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Merck & Co. (Rahway, NJ)
- …experience in drafting regulatory documents and interactions with global regulatory agencies requiredSelf-driven leader willing to advance Precision ... and Diagnostics, in this role, you will serve as the translational lead on late-stage immunology programs, driving the Precision Medicine objectives in alignment… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAbout the Role:-As a Technical Lead , you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a ... Review process change requests and deviation reports while ensuring regulatory compliance. Education and Minimum Requirements:Bachelor's degree in engineering,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company ... internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.-... GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionContainer Closure Integrity Testing Lead , Associate Principal Scientist, Analytical Research & Development The Analytical Research and Development ... innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and… more
- Merck & Co. (Rahway, NJ)
- …will be expected to function as an independent contributor, supporting global and site-specific projects, including those related to Combination Products and ... sites, External Manufacturing, R&D, Quality, Operations, Product Development groups, Regulatory Affairs, Procurement, and suppliers. Key Functions Work Independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for operational and technical oversight of QA across GxP (GCP/GVL/GCLP/GLP) systems. Lead the development of the global Data Integrity strategy and ... and disseminate educational materials and initiatives related to quality concepts across global teams. Lead and inspire cross-functional QA teams to implement… more
- Merck & Co. (Rahway, NJ)
- …- Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing ... Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant Supply:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... immune disorders. SummaryThe Executive Director, Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects ... ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... of companion diagnostics (CDx) strategy in support of projects and Global Project Teams within Daiichi Sankyo's Early and Late-Stage Development Portfolio.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... of laboratory data deliverables to support drug development processes and global submissions. This position provides leadership within Data Management by partnering… more
