- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …this role, a typical day might include the following:** + Responsible for CMC /CP product development activities to lead the regulatory standpoint during early ... for program-specific discussions, connect the dots across IOPS, proactively identify CMC /CP regulatory issues and develop appropriate strategies to mitigate… more
- BeiGene (Hopewell, NJ)
- …position plays a PM and CMC leading role in Technology Transfer and CMC regulatory filings by setting clear objectives and empowering their team. This ... position involves close collaboration within regulatory CMC , MS&T, Process Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory … more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …the CMC (Chemistry, Manufacturing and Controls) team of ITCI, **the** ** Senior Manager , Formulation Development** will be responsible for leading drug ... the Manufacturing and Supply Chain group of the ITCI CMC team. Responsibilities: + Lead and support activities for...veteran status, disability or any other legally protected status. Senior Manager , Formulation Development: Base Salary Range… more
- Sumitomo Pharma (Trenton, NJ)
- …a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager , Financial Planning & Analysis,** supporting our Technology and ... advisor to the T&Q organization, including VPs in Manufacturing, Quality, Supply Chain, CMC , and CPC, as it relates to Operating Expense Management. + Lead key… more
- BeiGene (Hopewell, NJ)
- The General Manager , Biologics Manufacturing USA will be providing leadership for the Biologics Manufacturing site in Hopewell, NJ, USA. This role will be ... but not limited to strategic planning, operational management, quality assurance, regulatory compliance, budget (P&L) management, and management of the site… more
- Integra LifeSciences (Plainsboro, NJ)
- …are challenging what's possible and making headway to help improve outcomes. This ** Senior Manager , Quality Operations** will manage and provide oversight on ... understand quality system requirements and how they impact product quality and regulatory compliance. + Works with Senior Management to achieve alignment… more
- Integra LifeSciences (Plainsboro, NJ)
- …and making headway to help improve outcomes. The **Project Engineering Manager ** is responsible for the technical and administrative leadership of facilities, ... support, and non-GMP spaces of the Collagen Manufacturing Center ( CMC ). Projects range from construction, equipment installation, rearrangements, specialty… more
- Taiho Oncology (Princeton, NJ)
- …procurement operations and external supplier development and management. Position Summary: Senior Manager , Outsourcing and Vendor Management, supports and ... Sr. Manager , Outsourcing & Vendor Management Princeton, NJ, USA...negotiation, and project award. + Ensures compliance with all regulatory and reporting requirements related to Supplier Diversity and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …managers, medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). **A ... The **Sr Manager , Clinical Drug Supply & Logistics** is responsible...within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Regeneron SOPs /… more
- Integra LifeSciences (Plainsboro, NJ)
- …to work onsite. **SUPERVISION RECEIVED** Under direct supervision of the Senior Manager , Manufacturing. **SUPERVISION EXERCISED** Directly supervises first shift ... is responsible for the skin and medical packaging production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality of… more