- 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
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Principal Scientist/ Associate Director , Process Chemistry - CMC , located at our South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...Francisco offices. Requirements What will you be doing? + Lead and oversee all aspects of process chemistry, ensuring… 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
- 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
- Sanofi Group (Swiftwater, PA)
- …products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global R&D. **Position Overview:** Sanofi's global ... (GRA) function is comprised of more than 1800 people. The Device Regulatory Lead for Specialty Care & Vaccine Combination Products will oversee key regulatory… 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
- 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
- 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 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
- Merck (West Point, PA)
- …Health, Process Development, Commercialization, Operations, Technical Operations, Analytical, Quality, Regulatory- CMC , and Supply Chain. Associate Director ... **Job Description** **Position Description:** ** Associate Director ,** **Technology Transfer** **(TT)** **Systems...Technology Transfer within Technical Product Leadership. This role will lead a team of scientists and engineers with a… 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
- 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
- University of Colorado (Aurora, CO)
- …applications, CMC , Facility Master File submission as needed and support Associate Director Quality in maintaining Facility Master File **Work Location:** ... three direct and four indirect reports, including Quality Assurance Associate Is and IIs. + Recruit, supervise, develop, and...+ Serve as the QA point of contact in CMC and Process Development and direct QA functional areas… more
- North Carolina Central University (Durham, NC)
- …of the students, faculty, staff and community patrons. The Music Library and the CMC ( Curriculum Center) located in the Music Building and School of Education, ... is to direct all administrative and executive support needs of the Office of the Director of Library Services , including the Director and Assistant Director… more