- 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)
- …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
- 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
- Sumitomo Pharma (Columbus, OH)
- …and management of the global contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates in drafting ... ** Associate Director , GMP Quality Control** Sumitomo...analyses, reports, and recommend product expiry extensions/reductions, as applicable. Lead and/or present at the Stability and Specification Review… more
- Merck (Rahway, NJ)
- … Associate Principal Scientist - Device Engineering and Early Development Lead ( Associate Director Equivalent)** _Our company's Device Development ... delivery and combination produce space to: + **Drive pipeline development.** Lead the core engineering technical device development team(s) supporting individual… 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
- Merck (West Point, PA)
- …Operations. We are seeking a highly motivated individual for the role of Associate Director , Tech Transfer Leader in Large Molecule Technology Transfer within ... Technical Product Leadership. This role will lead a team of scientists and engineers with a...Drug Substance and Drug Product for all large molecules. Associate Director is expected to contribute to… more
- Sanofi Group (Framingham, MA)
- …Culture Development department within CCD located in Framingham, MA in the role of Associate Director . We are looking for a candidate with excellent scientific, ... CMC , communication, and management skills to manage a team of upstream scientists and lead cross-functional projects. As a senior staff member of Commercial Cell… 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
- 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 (Bridgewater, NJ)
- …Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Specialist leverages their regulatory expertise to contribute ... business planning, governance, and committees. May be requested to lead Global Regulatory Team meetings + May represent GRT...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Sanofi Group (Bridgewater, NJ)
- …Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist leverages their regulatory expertise to contribute ... business planning, governance, and committees. May be requested to lead Global Regulatory Team meetings + May represent GRT...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Associate Director , Business Development will seek out potential business opportunities ... efficiently communicating with excellent facilitation. The incumbent will also lead initial partnership, licensing and/or acquisition negotiations with sufficient… more
- AbbVie (North Chicago, IL)
- …Clinical Pharmacology and Pharmacometrics management. Responsibilities: + Executes strategy, lead teams and various data analyses and interpretation by providing ... groups to provide a unified modeling and simulation position to clinical, CMC and regulatory teams. + Responsible for the appropriateness, quality and accuracy… more
- CSL Behring (Pasadena, CA)
- …Ensure regulatory compliance with cGMP, GSP, and other GxP requirements. + Lead tactical aspects of inspection readiness activities across global R&D manufacturing ... + Attend and provide Quality oversight for PDETs, Technical Transfer, and CMC meetings for new Product Development projects. + Manage performance and development… more
- AbbVie (Madison, NJ)
- …with multiple driver indications within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director , or Director , in the ... timely response to Health Authorities during application review. . Support CMC sections of major, complex regulatory submissions, including Investigation New Drugs… more
- UTMB Health (Dallas, TX)
- …Department (TJJD). **_JOB SUMMARY_** **:** Works under the direction of the Associate Medical Director . **_ESSENTIAL JOB FUNCTIONS (Medical Director )_** ... and recommends institutional policies and procedures that will enable UTMB CMC to maximize Digital Medical Services/Telemedicine. + Contributes to the development… more