- WuXi AppTec (Cranbury, NJ)
- …Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development, and the entire manufacturing supply chain under one roof. **Please… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** We are seeking an Associate Director , Regulatory Affairs CMC candidate to sit at our ... Foster City, CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director ...assessment exercises. + Coordinates and facilitates development of Regulatory CMC strategies with development and commercial project … 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
- Takeda Pharmaceuticals (Boston, MA)
- …international Health Authorities, as required. Participates in and/or leads agency meetings on CMC topics + Ensures project team colleagues, line management, and ... **Job Description** **OBJECTIVE / PURPOSE** + Providesprogram leadership and develops CMC regulatory strategy in support of global vaccine programs in various… 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
- Merck (Rahway, NJ)
- **Job Description** This Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from a Director , the ... and guidance for combination products (Drug and Drug Device combinations). The Associate Principal Scientist is responsible for the preparation and submission of… more
- Vera Therapeutics (Brisbane, CA)
- Title: Associate Director , Project Management Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage ... immunological diseases. Position Summary We are seeking a highly skilled and motivated Associate Director , Project Management. The ideal candidate will work… more
- WuXi AppTec (Cranbury, NJ)
- **Overview** ** Associate Director , Project Management (Oligo and Peptide)** **Area of focus: Discovery or medicinal chemistry** **Job Location: Remote USA ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof. **Job… 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
- Taiho Oncology (Princeton, NJ)
- Associate Director , Product Development Princeton, NJ, USA...a new and exciting role as part of growing CMC group at Taiho. You will be responsible not only ... the oncology space this is the role for you. Position Summary: + The Associate Director , Product Development will be responsible for product development, scale… more
- Merck (West Point, PA)
- **Job Description** We are seeking a highly motivated individual for the role of Associate Director , Biologics Drug Substance Lead within the Enterprise Go To ... Chain. The end-to-end scope includes Drug Substance for all large molecules. The Associate Director is expected to contribute to ongoing business process… more
- Lilly (Indianapolis, IN)
- …of the scorecards with the 3rd parties. The key responsibilities for a business/operations Associate Director or Director may include: + Works with BRD, ... from vendors by effective communication between vendor, finance and CMC PM teams. + Manage the collection of performance...overall capability and capacity of the team. + Attend project team meetings with collaboration partners as needed and… 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
- Lilly (Indianapolis, IN)
- …scale-up/optimization for Ph3 and commercial launches. **Responsibilities:** The Assoc. Director of TS/MS enables Operational Excellence by ensuring strong ... the Commercialization Lead Team ensuring alignment and communication with CMC and Oncology Business Unit. + Benchmark and network...to provide process stewardship day to day support and project support for new and existing products. + Ensure… more
- BeiGene (Emeryville, 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 (Morristown, NJ)
- **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
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description AbbVie is seeking an Associate Project Manager to drive the execution and oversight of ... (CPD-DD) to enable the early-stage pipeline. This will be in collaboration with our CMC team, CMC Product Development Director , and Delivery System Senior… more
- AbbVie (North Chicago, IL)
- …/ week* This position can be hired based on the following qualifications below: Associate Director , Clinical Pharmacology: + PhD with typically 4+ years of ... studies design, and clinical pharmacology strategy; acts as the representative for project (s). + Executes strategy, lead teams and various data analyses and… more
- Sanofi Group (Cambridge, MA)
- …work in a cutting-edge scientific global crystallization department in Sanofi's R&D CMC Synthetic organization. The job is in Cambridge MA, but close collaboration ... Expectations include; + Team Interactions - Facilitate close interactions with project team members such as Chemists, Analysts, Formulators and Engineers/Modelers to… more
- AbbVie (North Chicago, IL)
- …studies design, and clinical pharmacology strategy; acts as the representative for project (s). + Executes strategy, lead teams and various data analyses and ... functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Authors scientific publications and present at… more
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