- Lilly (Philadelphia, PA)
- …standards, and cost targets. + Collaborate with cross-functional team leaders, including development , CMC regulatory, manufacturing, and supply chain teams, to ... development and manufacturing and incorporate them into the CMC strategy. + Mentor and develop team members, providing...budget, and resource allocation, and provide regular updates to senior management. + Lead other tasks / projects as… more
- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... internal regulatory strategies and provides mentoring and coaching to Sr . Scientist and Assoc Principal scientist in support of...success together with risk mitigation measures. + Lead the development , communication, and review of the CMC … more
- Lilly (Philadelphia, PA)
- …requirements applicable to CMC regulatory in applicable geographies + Support CMC development projects as needed from CMC regulatory perspective ... for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for...maintain tools to effectively communicate the status of ongoing CMC regulatory projects to cross-functional teams and senior… more
- Integra LifeSciences (Plainsboro, NJ)
- …regulatory agencies. **SUPERVISION RECEIVED** Receives minimal supervision from the Director , CMC Quality Operations. **SUPERVISION EXERCISED** Manages personnel ... challenging what's possible and making headway to help improve outcomes. This ** Senior Manager, Quality Operations** will manage and provide oversight on Quality… more
- Novo Nordisk (Plainsboro, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position As Senior Medical Director for the novel modalities team, you will be part of ... About the Department Our East Coast Global Development Hub brings together the best minds in..., Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with… more
- Merck (West Point, PA)
- …Our company is seeking a highly motivated candidate for the position of Director , Vaccine Drug Product Development . Vaccine Drug Product Development ... key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure development ...mindset and collaboration with various partners and stakeholders in development The Director will report to the… more
- Novo Nordisk (Plainsboro, NJ)
- …monitoring, and data analyses. The International Medical Director will also assist the Sr . Medical Director in the development and execution of strategic ... About the Department Our East Coast Global Development Hub brings together the best minds in...help develop PRO and biomarker strategies. Relationships Reports to: Senior Director of the Liver Disease department.… more
- Organon & Co. (Plymouth Meeting, PA)
- … Director in Regulatory Chemistry, Manufacturing and Controls, the Senior Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls ... is responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products including original… more
- J&J Family of Companies (Spring House, PA)
- …of a cross-functional teams supporting pre-clinical and clinical programs, focused on CMC development . Primary responsibilities for this role include but are ... Johnson & Johnson is recruiting for an Associate Director , Cell Therapy Process Development based...external partners. + Communicate program progress and issues to senior management, to regulatory agencies as necessary, and at… more
- Taiho Oncology (Princeton, NJ)
- …across different spend categories, procurement operations and external supplier development and management. Position Summary: Associate Director , Outsourcing ... Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA...evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources… more
- Integra LifeSciences (Plainsboro, NJ)
- …are challenging what's possible and making headway to help improve outcomes. The Director , Manufacturing is a key member of the plant leadership team responsible for ... leading the overall manufacturing operations for Integra's Collagen Manufacturing Center ( CMC ), working within FDA medical device regulations and ISO Standards.… more
- Amicus Therapeutics (Princeton, NJ)
- Executive Director , Program Management Location Princeton, NJ Requisition ID 2277 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1323) Executive Director , Program Management Amicus Therapeutics is a global, patient-dedicated… more
- Merck (West Point, PA)
- …(GFLS) and inline lifecycle management (change control) + Understanding of product development lifecycle and integration of CMC and clinical strategy to ... of brand operating metrics. The VCM PL will partner with the Product Development Team (PDT), Development and Commercialization Team (DCT), and Global Brand… more