- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the ... as point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with supervision. Prepares… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Merck & Co. (Rahway, NJ)
- …operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs.... - At least 8 years of experience in project management . - - At least 5 years… more
- Merck & Co. (Rahway, NJ)
- …and fusion proteins. Within Mixed Modality, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose ... with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of portfolio, initiatives… more
- Eisai, Inc (Exton, PA)
- …technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing scientific ... groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... this role, the successful candidate will be responsible toCoordinate project planning, resourcing, progress reporting, troubleshooting and people management.Serve as… more
- Xaira Therapeutics (Brisbane, CA)
- …Seattle, and London. About the Role We are seeking a highly skilled and proactive Associate Director , Research Project Manager to oversee the planning and ... research through IND submission. The ideal candidate will bring deep expertise in project management tools and practices, and will play a critical role in driving… more
- Cytokinetics (South San Francisco, CA)
- …individuals who are driven to make a positive impact. Job purpose As the Associate Director of Toxicology, you will play a critical role in advancing ... to design and manage non-clinical safety studies, provide strategic input to project teams, and ensure the highest standards of scientific and ethical conduct.… more
- ADMA BIOMANUFACTURING LLC (Boca Raton, FL)
- …consider ADMA Biologics. We currently have an exciting opportunity available for an Associate Director , Regulatory Affairs - Plasma Services in Boca Raton, ... Florida! The Associate Director , Regulatory Affairs - Plasma Services...and Establishment License Applications, and other related documents or CMC supplement submissions as directed to support the company.… more
- Olema Oncology (San Francisco, CA)
- …feel better, longer. For more information, visit us at www.olema.com. About the Role Associate Director , GMP Quality Assurance As the Associate Director ... our CMOs and distribution networks as well as internal CMC and Clinical Supply Chain groups. You will also...workload in order to facilitate meaningful, timely outcomes Excellent project management and organization skills The base pay range… more
- Shuvel Digital (Reston, VA)
- …thinker with strong problem-solving and decision-making abilities. Desired Relevant Certifications: Project Management Professional (PMP) Certified Associate in ... Has supervisory and developmental responsibilities within a functional area. The program director manages one or more projects or programs, may manage an operating… more
- WuXi AppTec (Boston, MA)
- **Overview** The AD Project Manager will be responsible for managing projects within STA, WuXi's API, and Drug Product development and manufacturing division. Leads ... the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team.… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee ... CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for...CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you… more
- BeOne Medicines (San Mateo, CA)
- …implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global ... product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for...lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and investigator brochures,… more
- Lilly (Indianapolis, IN)
- …Applications, post-approval supplements/ variations and responses to questions. **Oversight of CMC Project Deliverables** + Ensures appropriate definition and ... better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC ...qualified for the work assigned to them and the project responsibilities associated with their position. + Ensures that… more
- UTMB Health (Huntsville, TX)
- …skills. **_SUPERVISION:_** + Received: Associate Vice President Pharmacy Services, CMC + Given:Assistant Director , Pharmacy Staff **_BUDGET RESPONSIBILITY:_** ... Director Pharmacy Service - CMC Huntsville...the pharmaceutical supply chain. + Uses advanced communication and project management skills to lead quality and efficiency improvement… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Associate Principal Scientist ( Associate Director ) is responsible for developing and implementing Regulatory ... development, marketing applications and post-approval life cycle maintenance phases. The Associate Principal Scientist may also support project team goals… more
- Merck (Upper Gwynedd, PA)
- **Job Description** GRACS CMC - Associate Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- BeOne Medicines (Emeryville, CA)
- **_General Description:_** Sr. Manager/ Associate Director , Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... initiatives with Contract Manufacturers (CMO) + In partnership with Quality, CMC , Procurement, Supply Planning to ensure manufacturing performance, cost objectives… more
- Merck (West Point, PA)
- …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
