- 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. (Rahway, NJ)
- …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.... - At least 8 years of experience in project management . - - At least 5 years… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC , and Clinical Development to collate the necessary information to ... participate/contribute to discussions in applicable working teams, technical teams, project teams, etc. Qualifications: Successful candidates will be able to… more
- WuXi AppTec (Cranbury, NJ)
- **Overview** STA Pharmaceutical, a WuXi AppTec Company, has an exciting opportunity for an ** Associate Director , CMC Project Management.** This position ... lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs Chemistry, Manufacturing and Controls ( CMC ) works ... Leads initiatives internal to RA CMC . + Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the… 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
- 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
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Biologics CMC , a part of Development Sciences within AbbVie's R&D, is a ... LNPs, Cell Therapy). We are looking for a Biologics CMC Data Strategy Lead who will develop, oversee and...DSDT efforts remain connected to them + Resolve key project hurdles by establishing and fostering partnerships with key… 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 (Rahway, NJ)
- …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
- 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
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Technical position within the Product, Development, ... responsible for financial planning and timeline estimates of the project as well as execution. + Responsible for implementation...and manufacturing plants as well as process improvement and CMC support of marketed products. The role also includes… more
- Rhythm Pharmaceuticals (Boston, MA)
- …experienced and highly motivated individual to join its team in Boston, Massachusetts. The Associate Director will be the technical lead for Drug Product small ... Requests for Proposals (RFPs). + Collaborates with internal stakeholders, including CMC Drug Substance, Supply Chain Management, Quality, and Regulatory Affairs. +… more
- University of Southern California (Los Angeles, CA)
- cGMP Associate Director , Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP- ... cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director , Regulatory Data Governance Lead **POSITION DESCRIPTION** : ... Takeda Development Center Americas, Inc. is seeking an Associate Director , Regulatory Data Governance Lead with the following duties: Oversee the establishment… more
- Merck (Wilson, NC)
- …Description:** We are seeking a highly motivated individual for the role of Associate Director , Tech Transfer Leader supporting the Wilson Packaging Technical ... and packaging technology and components. Experience also includes strong project management skills and utilization of program/portfolio management tools with… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Associate Director , Clinical Pharmacology & Pharmacometrics will be responsible for developing and executing clinical pharmacology ... cross-functional teams such as Clinical Development, Biometrics, Biomarkers, Regulatory, CMC etc. Responsibilities will include planning and reviewing study designs… more
- Sanofi Group (Cambridge, MA)
- **Job title** : GRA Device Lead ( Associate Director ) **Location:** Cambridge. MA **,** Morristown, NJ **About the Job** Are you ready to shape the future of ... team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development....represent the GRA Device perspective as a member of project specific cross functional global regulatory team (GRT) and… more
- Sumitomo Pharma (Phoenix, AZ)
- …Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical pharmacology, and ... drug metabolism and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work across… more
