- 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
- 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
- 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
- AbbVie (North Chicago, IL)
- …interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams in planning, preparation, review and approval of drug ... with CMC Regulatory and Process R&D. + Partner with CMC Regulatory to assist CMC project teams in identifying submission-related risks and develop… 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
- AbbVie (Florham Park, NJ)
- …@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
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/ Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...cultivating vendor relationships + Supervising third-party activities and delivering project updates with recommendations Traits we believe make a… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... portfolio biologics and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change implementation.… more
- Merck (North Wales, PA)
- …in the Research & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of ... and realize its full potential. The Associate Director is expected to provide project management...from diverse disciplines (eg, clinical, regulatory, market access, manufacturing, CMC , commercial, and other areas) as applicable to the… 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
- Merck (Boston, MA)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point ... & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs...preferred. + At least 8 years of experience in project management. + At least 5 years of experience… 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
- 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
- Takeda Pharmaceuticals (Lexington, MA)
- …to the best of my knowledge. **Job Description** **Objective / Purpose:** As an Associate Director in Analytical Development, it is expected that the individual ... by Design (AQbD) + Experience in reviewing and approving analytical-related CMC sections of BLA/MAA regulatory submissions. Knowledgeable in European, Japanese,… 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
- Merck (West Point, PA)
- **Job Description** The LMAS Critical Reagents Associate Director will provide technical leadership and implementation support for qualification activities, key ... lead the organization through this transformative change. As a LMAS Critical Reagents Associate Director for Large Molecule Critical Reagents, this role is… more