- 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
- J&J Family of Companies (Titusville, NJ)
- …Communicates critical issues to Management **Sphere of Authority** + Ensures the CMC development and commercial product regulatory strategy meets global ... Associate Director , CMC Regulatory Affairs - 2406221330W...an individual with expertise in parenteral and general pharmaceutical development to guide the CMC and regulatory… 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
- J&J Family of Companies (Spring House, PA)
- Sr Director - Head of Tech, Therapeutic...Johnson is currently recruiting for a Senior Director - Head of Technology, Therapeutic Development and ... Learn more at https://www.jnj.com/ . The Senior Director , Head of Technology - Therapeutic Development ...to enable, accelerate and amplify the work of the CMC and Clinical Supply Engine to deliver the J&J… 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
- 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
- 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 ... Associate Director , Cell Therapy Process Development -...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