- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... tight timelines, in a rapidly changing environment.Experience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed… more
- Boehringer Ingelheim (Ridgefield, CT)
- …currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at ... activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director of EACD for drug… more
- Lilly (Philadelphia, PA)
- …new medicines, and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the ... on-site at the Philadelphia office. **Responsibilities:** + Serve as the CMC Lead for one or more development assets, ensuring integrated planning, execution,… more
- AbbVie (North Chicago, IL)
- …Tok (https://www.tiktok.com/@abbvie) . Job Description The Pharma Product Group Associate Director will be fully accountable for providing CMC leadership and ... Independently lead complex cross-functional PDS&T product teams. Represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations… more
- AbbVie (North Chicago, IL)
- …assure timely impact assessment, and implementation of new regulatory requirements. Will lead CMC Coordination activities for later stage and more complex ... interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams in planning, preparation, review and approval of sections of … more
- BeOne Medicines (San Mateo, CA)
- …and process optimizations on relevant topics. **Essential Functions of the job:** + Lead , develop and implement small molecule CMC regulatory strategies as well ... CMC regulatory strategies for the assigned projects. + Lead regulatory risk assessment, identify key CMC ...+ Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product… more
- Organon & Co. (Jersey City, NJ)
- …regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for programs in ... **Job Description** **The Position** The Associate Principal Scientist ( Associate Director...are not limited to: **Responsibilities** + Serve as the CMC Product Lead or support the … more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **About the role:** As a CMC Lead , Small Molecules ( Associate Director ), you will be responsible for leading ... and to perform the global reporting of process performance. + Lead multiple CMC teams with competing priorities. + Able to determine priorities within… more
- Danaher Corporation (Fargo, ND)
- …management of already established contracts and project/program execution. This position reports to the Director of Drug Product CMC and is part of the Drug ... be fully onsite. In this role, you will have the opportunity to: + Lead Program and Project Execution: Oversee the planning, execution, and successful delivery of… more
- AbbVie (Worcester, MA)
- …. Job Description The primary goal of this position is to lead the digital transformation effort for PDS&T Biologics. The selected individual will ... and digital strategy, influencing and driving end-to-end digital integration within Biologics CMC . This leader will collaborate closely with IT partners to evaluate… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... drug product at CDMOs + Design and lead method validation and implementation activities for drug substance and drug product ensuring compliance with relevant ICH and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …application is true to the best of my knowledge. **Job Description** ** Associate Director , Clinical Research, Value & Evidence Generation, US Medical** ... objectives include: + Partners with Head of US Medical Clinical Science Lead to translate strategy into efficiently executable research plan; predicting and planning… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Health and a Brighter Future to people worldwide. As an Associate Director in Analytical Development, you will lead efforts to develop advanced analytical ... separation-based techniques (eg, U/HPLC, CE-SDS, icIEF, glycan profiling, etc), you will lead a team to ensure analytical methods and strategies meet scientific,… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …medicines to patients faster. We are seeking an experienced and highly motivated Associate Scientific Director to join the Integrated Technology and Engineering ... **Business Unit Summary** Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve… more
- University of Southern California (Los Angeles, CA)
- cGMP Associate Director , Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP- ... cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, ... the area of Biosimilar/BLA submissions including strategize, compile, review and manage/ lead regulatory submissions. Subject matter expert in the area of Biologics.… more
- AbbVie (Barceloneta, PR)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The ME&C Associate Director is a global program management expert responsible ... projects across disciplines and multiple manufacturing locations. They organize and lead high-performing cross-functional teams in the planning and execution of… more
- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking an Associate Director / Director of Drug Substance Manufacturing for a direct hire opportunity with a leading ... Senior Director , $275,000 - $320,000 **Overview** As Associate Director / Director , Drug...our investigational and commercial portfolio. Reporting to the Senior Director of CMC , you'll be instrumental in… more
- Bristol Myers Squibb (Seattle, WA)
- …+ Technology transfer and process validation across the product lifecycle + CMC lifecycle management and regulatory strategy + Oversight and governance of global ... to ensure performance, alignment, and compliance with BMS standards. + Lead global forums to harmonize manufacturing processes, control strategies, and lifecycle… more
- Merck (Rahway, NJ)
- …regulatory submissions. Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... timelines, in a rapidly changing environment. + Experience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed teams. +… more
