- 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
- 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
- Sanofi Group (Swiftwater, PA)
- **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
- 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
- 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
- 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
- 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
- Merck (Rahway, NJ)
- …sight to process validation and commercial launch. This role reports into the Associate Vice President, Sterile Products Development. This role is located in Rahway, ... of sight to commercial production + Oversee and review CMC authoring activities for DP manufacturing + Ensure successful...process analysis and control throughout the lifecycle + Attract, lead , and develop a world-class team of scientists and… 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
- 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