- WuXi AppTec (Austin, TX)
- **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
- 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
- BeOne Medicines (Emeryville, 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
- Sanofi Group (Framingham, MA)
- **Job Title:** Associate Director - CMC BioDPDM **Location** : Framingham, MA As Associate Director within CMC BioDPDM, you'll have the opportunity ... could turn the impossible into possible for millions. The Associate Director role is a key leadership...Director role is a key leadership role in CMC Biologics Drug Product Development and Manufacturing. You will… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director , Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and ... lifecycle. This role blends deep regulatory expertise with advanced project management skills, driving successful NDA/BLA/MAA submissions and ensuring… more
- Sumitomo Pharma (Honolulu, HI)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... (HA) information requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory input as… more
- AbbVie (North Chicago, IL)
- …and automation systems strategy and roadmap in alignment with department objectives and SM CMC R&D strategies. . Develop and revise project plans and budgets, ... ongoing basis . Provide guidance, technical advice, planning, and project management within SM CMC and with...advice, planning, and project management within SM CMC and with outside functions, consultants, and vendors. Support… more
- Novo Nordisk (Boulder, CO)
- …we are driving change. Are you ready to make a difference? The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug ... About the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics. The CMC team works… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …true to the best of my knowledge. **Job Description** **About the role** As Associate Director , API Process Engineering, you will be Takeda's global expert for ... site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing applications for global… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** GRA Device Lead ( Associate Director ) - Digital Health **Location:** Cambridge, MA/ Morristown, NJ **About the Job** GRA Device Lead ( Associate ... of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The...GRA Device Lead for DHTs and SaMDs on assigned project teams (early phase, late stage and marketed products)… more
- Sanofi Group (Waltham, MA)
- **Job Title:** Associate Director , Genomic Medicine Purification Process Development **Location:** Waltham, MA Work Model: M-F onsite **About the Job** Are you ... our teams accelerate progress. The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment...Group located in Waltham, MA in the role of Associate Director . The GMU PPD group operates… 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
- University of Southern California (Los Angeles, CA)
- …cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all ... including manufacturing and process development activities, in order to ensure that project deliverables meet schedule, cost, scope, quality, and safety and ensuring… more
- Merck (Rahway, NJ)
- …material handling, and the ability to integrate new technologies and cell-line platforms. The Associate Director , Process Operations Lead will be a member of the ... a key part of our Chemistry, Manufacturing, and Controls ( CMC ) hub at our site headquarters in Rahway, NJ....Operations. **Job Responsibilities:** + Strategic member of the capital project delivery project team providing Operational knowledge… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Strategic Sourcing & Supplier Management, Medical Devices ... high complexity. + Communicates issues to line manager and project teams in a timely manner + Support product...management software + Understanding of activities related to the CMC development of biopharmaceuticals + Advanced knowledge of GMPs… more
- Lilly (Indianapolis, IN)
- …solutions to support communities through philanthropy and volunteerism. **Responsibilities:** The Associate Director - API EM Engineering Leader for Peptides ... and process improvement. + Demonstrated ability to manage capital delivery project or commercialization / technical agenda projects + Deep technical knowledge… more
- BeOne Medicines (Pennington, NJ)
- **General Description:** The Associate Director Quality Control (QC) will lead analytical strategy, method lifecycle management, and QC operations to support GMP ... external vendor management. This position is in Hopewell, NJ reporting into the Director , QC Operations. **Essential Functions of the Job:** + Develop and oversee… more
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. As the Associate Director - Test Methods/Systems in IDM you will oversee and coordinate the ... progress and manage change through regular updates to management teams, CMC project management, and site leadership. + Deliver responsive support for… more
- RTX Corporation (Pueblo, CO)
- …Do:** + Leads and directs site-based AMF Program Engineering Senior Managers, Carbon R&D Associate Director and the Dyno Test Lab Manager that report to this ... **Security Clearance:** None/Not Required Collins Aerospace is seeking an experienced ** Director , Materials and Process Engineering.** This role will be responsible… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …key strategic questions that drive our enterprise forward. Reporting directly to the Associate Director or Senior Director , Development to Launch Analytics, ... to proactively identify and address priority business questions related to CMC development, new product introduction and business operations. This includes all… more