- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing and ... the probability of regulatory success together with risk mitigation measures.Lead the development , communication, and review of the CMC Regulatory Strategy… more
- 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
- J&J Family of Companies (Malvern, PA)
- Johnson and Johnson is currently recruiting for a Senior Director - Head of Technology, Therapeutic Development and Supply within the Johnson & Johnson ... humanity. 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
- 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
- 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
- CSL Behring (King Of Prussia, PA)
- …drug development projects.** **Strong knowledge in drug research, development and manufacturing processes of pharmaceuticals ( CMC , non-clinical, clinical, ... often rare conditions. Could you be our next Associate Director , R&D Project Planning Capability Lead? This position is...management practices to support the delivery of our drug development pipeline. You will lead initiatives to develop and… 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