- J&J Family of Companies (Boston, MA)
- Associate Director , CMC Regulatory Affairs - 2406221330W **Description** Johnson & Johnson is recruiting for an Associate Director , CMC ... of development and commercialization. This person is responsible for developing global CMC regulatory strategies. The primary responsibility is to work on… more
- AbbVie (Worcester, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing ... + Participate in the planning/design, conduct, analysis, and interpretation of CMC studies and regulatory submissions. Participate in establishing departmental… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , CMC Program Lead, Cell Therapies in Cambridge, ... and product quality improvement in Chemistry, Manufacturing & Control ( CMC ) processes; Employ technical project management principles (project planning, RACI,… more
- AbbVie (Worcester, MA)
- …Instagram, YouTube and LinkedIn. Job Description Position will be responsible for CMC leadership and project management for existing and new biologics projects from ... manufacturing, process development and process characterization to management and to regulatory agencies. *Prepare and review regulatory briefings and… more
- WuXi AppTec (Natick, MA)
- …needs in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof. With over… more
- Editas Medicine (Cambridge, MA)
- …as a passion to lead, mentor and influence people. Characterizing Your Impact: As the Associate Director , LNP Process Development you will: + Lead and grow a ... also be a key contributor to the overall program CMC strategy. This role requires strong technical expertise in...stakeholders and external partners + Author and review of regulatory submissions, technical reports, SOPs and work instructions +… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Associate Director , Upstream MSAT **Location:** Framingham, MA **About the Job** We are an innovative global healthcare company with one purpose: ... you thought was possible. Ready to get started? The Associate Director position is part of the...responsible for preparing reports and other internal documentation for regulatory purposes. + Collaborate with MSAT and CMC… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking an enthusiastic ** Associate Director , Program & Portfolio Management** to drive programs forward at Regeneron Cell Medicines (RCM) through ... on programs that are in IND-enabling studies through clinical study execution. **As an Associate Director , Program & Portfolio Management at RCM, a typical day… more
- AbbVie (Worcester, MA)
- …functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Authors scientific publications and present ... Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals… more
- AbbVie (Worcester, MA)
- …functional groups to provide a unified modeling and simulation position to clinical, CMC and regulatory teams. + Responsible for the appropriateness, quality and ... support development plans and strategies to achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD modeling and simulation… more
- Takeda Pharmaceuticals (Boston, MA)
- …experience within related functions (eg Clinical Science, Clinical Operations, Research, Regulatory , CMC , Marketing) + 3-5 years program management experience ... leading complex pharmaceutical projects in a multi-disciplinary, global environment + Demonstrated ability to positively influence outcomes, key project decisions, and strategic problem-solving + Proven ability to communicate clearly and present key… more