- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC ... 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …(including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS- CMC Associate Director , Biologics will serve as the ... Sciences (GRS) and Global Product and Supply (GPS). The GRS- CMC Associate Director , Biologics will...of global change management. **Position Responsibilities** + Represent regulatory CMC on and/or lead matrix teams for… more
- AbbVie (North Chicago, IL)
- …scope. + Lead cross-functional PDS&T product teams and represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations functions, other ... or functions or outputs of this position. Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule… more
- AbbVie (North Chicago, IL)
- …management approach; Key member of Asset Strategy Team (AST) and ensures CMC strategy is closely aligned with the clinical and regulatory development strategy. ... Lead DevSci cross-functional initiatives and strategies. From GLP tox...transfer to commercial manufacturing sites. Accountable for creating a CMC development plan in collaboration with line functions and… more
- Teva Pharmaceuticals (West Chester, PA)
- …4 direct reports (Dir, Sr Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is responsible for identifying and evaluating CMC ... Senior Director Regulatory Affairs CMC (Biologic Products)...dossiers to be submitted to foreign Health Authorities. ⦁ Lead the review of internal CMC controlled… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …for all vendor workshops and programs. + Provides monthly reporting and oversight of CMC budget and assists Associate Dean with budget forecasting. + Ensures web ... community. **Description** The Goizueta Business School is searching for a Senior Director , Operations to support all operational activities for the Graduate Career… more
- Bristol Myers Squibb (Devens, MA)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position:** ASL Associate Director , Analytical Strategy & Lifecycle Group Lead **Location** : ... Cruiserath / Devens The Associate Director of Analytical Strategy & Lifecycle will ...(GQCAS) pillar. Key responsibilities include ownership of the analytical CMC strategy, which encompasses strategic oversight of drug substance… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
- Bristol Myers Squibb (Summit, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Title:** ** Associate Director , MS&T Site Lead ** **Location: Summit, NJ** ... transfer, scale-up, facility fit, and execution of Gene delivery material supply. The ** Associate Director of Manufacturing, Science, and Technology** at the S6A… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing ... serve as G-RACMC lead or regional submission lead . Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams… more
- Sanofi Group (Cambridge, MA)
- **Job title: Device Regulatory Lead ( Associate Director )** + Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global ... team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global R&D. This critical...get started? **Main responsibilities** + Serve as Device Regulatory Lead on assigned project teams (early phase, late stage… more
- RTX Corporation (Forest, MS)
- …the Radio Frequency Solutions (RFS) Sub-Strategic Business Unit (sSBU) is looking for an Associate Director , Supply Chain Management (SCM) in support of the RFS ... Location: MS301: 19859 Highway 80, Forest 19859 Highway 80 CMC Forest, Forest, MS, 39074 USA Position Role Type:...a dynamic and complex supply chain organization. They will lead the SC personnel assigned to the program areas… more
- Novo Nordisk (Boulder, CO)
- …are driving change. Are you ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design, development ... development and scaling of small molecules, oligonucleotide intermediates and API's. The Associate Director is expected to implement novel strategies towards… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director of Protein Production where you will be an inspirational, ... Analytical Sciences team, you will report to the Senior Director of the team and work with the Global...team and work with the Global Biologics organization and co- lead biologics discovery programs along with therapeutic area leads.… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Associate Director of Drug Substance - EACD will have the primary responsibility to oversight process development and manufacturing ... of clinical/commercial stage small molecule APIs. Reporting to the Director of EACD, this individual will provide guidance to...& timelines + Serve as the drug substance technical lead on CMC teams and coordinate activities… more
- Novo Nordisk (Watertown, MA)
- …Development - Boston and will work closely with other functions of CMC drug development, including Drug Product, Analytical Sciences, Quality Assurance, and Supply ... larger Chemical Development organization anchored in Denmark. Essential Functions + Lead and manage external API development and manufacturing activities +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** The Associate Director , Clinical Research provides clinical project management and leadership ... responsibilities, which can include project management processes and systems. + Lead and matrix-manage high performing study teams, collaborating across the… more
- Frontier Medicines (South San Francisco, CA)
- Frontier Medicines is seeking a highly motivated individual for a newly created Associate Director role in Process Chemistry in Frontier's South San Francisco ... and scale-up challenges + In collaboration with the Development Project Lead and/or CMC Head, define timelines, production scale, and budget to support all… more
- J&J Family of Companies (Spring House, PA)
- Associate Director , Cell Therapy Decisional Analytics - 2406185128W **Description** Johnson & Johnson is recruiting an Associate Director , Cell Therapy ... We are looking for an energetic and highly motivated Associate Director candidate with demonstrated expertise in...and lentiviral vector process development. The successful candidate will lead a team focused on the development and rapid… more
- Sanofi Group (Framingham, MA)
- Associate Director , Commercial Cell Culture Development Location: Framingham, MA **About the Job** Are you ready to shape the future of medicine? The race is on ... progress. Join our global Cell Culture Development (CCD) organization as the Associate Director , Commercial Cell Culture Deveopment with the mission to… more