- 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
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of ... this position you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC … 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
- 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
- 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
- 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
- RTX Corporation (Pueblo, CO)
- …**Security Clearance:** None/Not Required Collins Aerospace is seeking an experienced Associate Director of Carbon Engineering (AD-CE). This position reports ... directly to the Director of Carbon Engineering in Pueblo, CO. This role...Springs, CA. The three sites are referred to as Associate Manufacturing Facilities (AMF) as part of Troy, OH… 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
- Sumitomo Pharma (Nashville, TN)
- …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
- AbbVie (Cambridge, MA)
- …to ensure an in-depth understanding of the science behind each of these opportunities. The Associate Director , Search & Evaluation will be a key member of the ... industries required + Background in metabolic disease preferred + Strong Project management/ leadership skills to lead/manage multifunctional teams to evaluate… 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
- Daiichi Sankyo Inc. (Basking Ridge, 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
- 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
- Lilly (Indianapolis, IN)
- …saving therapeutics. **Role Overview:** We are seeking a veteran and visionary Sr. Director of Early Phase Chemistry to join our leadership team. This individual ... as overseeing external programs at CDMOs. This role will report to the Associate Vice President in SMDD. **Key Responsibilities** _People & Team Management_ + Create… more
- Takeda Pharmaceuticals (Exton, PA)
- …of my knowledge. **Job Description** **About the role:** Join Takeda as a Director , US Medical Clinical Research - Medical Engagement & Innovation where you will ... Medical Affairs team, you will report to the Sr. Director & Head, US Medical Clinical Science, Clinical Research...study strategic vision and remit for study team, coaches Associate Directors and Clinical Sr/Research Managers. + Assurance of… more
- Shuvel Digital (Reston, VA)
- …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
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