- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies ... 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
- Novo Nordisk Inc. (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
- Merck & Co. (North Wales, PA)
- Job Description Position Description: Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease The Regulatory Affairs Headquarters ... Associate Principal Scientist supports products in the Vaccine and...reports. The individual may also assist or take the lead in tracking, authoring, shepherding and/or review of responses… 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
- Insmed Incorporated (Bridgewater, NJ)
- …programs. This position will be the dynamic cross-functional interaction between lead optimization research and early CMC development.Responsible for the ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the… more
- Merck & Co. (Rahway, NJ)
- …to process validation and commercial launch.- This role reports into the Associate Vice President, Sterile Products Development. This role is located in Rahway, ... in human through line of sight to commercial productionOversee and review CMC authoring activities for DP manufacturingEnsure successful and effective technology and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head as part ... This individual will be responsible for a global operational strategy and investigations lead / owner for a best-in-class high volume marketed CAR-T product as part… more
- 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
- 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 (Summit, NJ)
- …careers.bms.com/working-with-us . **Position Summary** Bristol Myers Squibb is seeking an Associate Director , Principal Product Leader within the Cell Therapy ... The Principal PQL will support the Global Product Quality Lead (PQL) by providing supportive quality oversight of the...+ May act as author or Quality reviewer of CMC sections of regulatory submissions and response to global… 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
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - Remote OR West Chester, PA Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... difference with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you will be...responsible for acting as and supporting the Global Regulatory Lead (GRL) in strategic vision and innovative scientific and… 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
