- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. **Position Summary:** The Associate Director , CMC Project Management will provide strategic ... enable investment strategy optimization at both project and portfolio level. The Associate Director , CMC Project Management may also partner with the… more
- J&J Family of Companies (Columbus, OH)
- Associate Director , CMC Regulatory Affairs - 2406221330W **Description** Johnson & Johnson is recruiting for an Associate Director , CMC ... communication skills + Communicates cross-functionally and cross-company. Presents and defends CMC management-approved regulatory strategy and opinion to project … more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global ... of country specific CMC regulatory strategies + Lead CMC regulatory submissions including overall submission project , cross-functional communication,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The project ... based on the project needs and the respective development stage of the project . The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage … more
- AbbVie (North Chicago, IL)
- …CMC development experience through IND and/or NDA/MAA. + Experience leading multiple CMC project teams through IND and NDA/MAA preferred. + Technical ... in writing, presentation, and overall communication. + Demonstrated excellence in leading CMC project teams. Additional Information Applicable only to applicants… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director , Analytical Regulatory Sciences, Systems & Operations in ... site based position located in Foster City, CA_** The Associate Director , Analytical Regulatory Science, collaborates with... CMC RA Team Leads to provide one CMC RA voice to PDM project teams… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the ... Acts as point of contact to cross-functional teams on US/EU RA CMC project issues. + **Execution of Strategy and Submissions:** Develops strategy with… more
- Regeneron Pharmaceuticals (Troy, NY)
- …preferably related to health, environment or politics or related degree and: + Associate Director : 15+ years of related experience in regulated industry or ... The Director of CMC Industry and Regulatory...Strong communication skills, both oral and written. + Strong project management leadership skills essential + Good understanding of… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , CMC Program Lead, Cell Therapies in Cambridge, ... productivity and product quality improvement in Chemistry, Manufacturing & Control ( CMC ) processes; Employ technical project management principles ( project… more
- AbbVie (Worcester, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing ... areas with a focus on Chemistry, Manufacture and Control ( CMC ), expanding and broadening the application of Biostatistics. He/she...or seeking help from others + Able to manage project timeline and quality of deliverables + Able to… more
- Organon & Co. (Plymouth Meeting, PA)
- …Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist ( Associate Director ) is responsible for Regulatory ... Chemistry Manufacturing & Controls ( CMC ) aspects of clinical phase through market product registration...encompass late-stage development products and commercially approved compounds. The Associate Principal Scientist may also support project … more
- AbbVie (Worcester, MA)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description Position will be responsible for CMC leadership and project management for existing and new biologics ... projects from the drug substance perspective. Responsibilities: *Develop comprehensive project plans, budgets, timelines and strategy; biologics projects at all… more
- WuXi AppTec (Natick, MA)
- …drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof. With over ... drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC dossiers to support… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Associate Director , R&D Project Planning Capability Lead? This position is ... Prussia PA office. It is a Hybrid role. The Associate Director , R&D Project Planning...in drug research, development and manufacturing processes of pharmaceuticals ( CMC , non-clinical, clinical, and regulatory).** **Expert level skillset in… more
- Vera Therapeutics (Brisbane, CA)
- Title: Associate Director , Project Management Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company ... Summary We are seeking a highly skilled and motivated Associate Director , Project Management. The...with other functional areas including Clinical, Clinical Operations, and CMC . * Provide project management support for… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …academic community. **Description** The Goizueta Business School is in search of an Associate Director - Graduate Student Advising and Programming to join the ... Management Center team. This position will report to the Director of Specialized Master's Programs at the Goizueta Business...of Finance) Programs served by the Career Management Center ( CMC ). + Develops the overall student advising strategy and… more
- Lilly (IN)
- …communities through philanthropy and volunteerism. ** ** **Position Summary:** The Associate Director , Clinical Supply Management has responsibility for the ... delivery of clinical supplies across the oncology portfolio. + Communicate with CMC and clinical partners to outline potential risks, limitations, and mitigation… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Ensures timely preparation of organized and scientifically valid… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... dynamic and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your...Proposal (RFP) through contract execution for clinical studies and CMC projects as well as ongoing governance with key… more
- Bristol Myers Squibb (San Diego, CA)
- …team, RayzeBio aims to be the global leader in radiopharmaceuticals . The Director / Associate Director of Radiochemistry will lead the Discovery ... working across multiple modalities such as peptides, small molecules, and antibodies. The Director / Associate Director will also be responsible for innovating… more