- 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
- Cedent (Cambridge, MA)
- …including strategy development, global submissions, agency meetings, and expedited designations; CMC experience is a plus. Experience in ophthalmology is an ... advantage. Project management experience is beneficial. Strong oral and written communication skills. Comprehensive understanding of global pharmaceutical… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …employment application is true to the best of my knowledge. Job Description Associate Director , Clinical Research, Value & Evidence Generation, US Medical ... Lexington, MA Hybrid OBJECTIVES/PURPOSE: Provides clinical project management and leadership to ensure successful operational execution of all US Medical Clinical… 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
- J&J Family of Companies (Malvern, PA)
- …as a single submission. **We are searching for the best talent for an Associate Director , CAR-T Analytical Scientific Integrator - Advanced Therapies to be ... located in Malvern, PA or Leiden, Netherlands.** **Purpose:** The Associate Director , CAR-T Analytical Scientific Integrator will provide analytical, technical… more
- Takeda Pharmaceuticals (Lexington, MA)
- …application is true to the best of my knowledge. **Job Description** ** Associate Director , Clinical Research, Value & Evidence Generation, US Medical** ... **Lexington, MA** **Hybrid** **_OBJECTIVES/PURPOSE:_** Provides clinical project management and leadership to ensure successful operational execution of all US… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Drug Substance Commercial Development **Location** : Cambridge, MA **About the Job** Are you ready to shape the future of ... join our growing Commercial Process Development team as an Associate Director . Under the direction of the...with analytical chemists, process engineers, pilot plant experts and project managers within the CMC Synthetics organization… more
