- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee the development ... Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and manage regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of ... beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has… more
- WuXi AppTec (Boston, MA)
- …of 5 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing. + Working knowledge and understanding of ... problems **Leadership Activities:** + Work closely with team members across all CMC -related business units and with the STA management team to ensure coordination… more
- Takeda Pharmaceuticals (Lexington, MA)
- …This role is within in the R&D GRA Chemistry Manufacturing & Controls ( CMC ) and Devices organization, and will contribute to the team's delivery of critical ... follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA … more
- Sanofi Group (Framingham, MA)
- …Bioanalytics Characterization and you'll be able to play a key role in supporting CMC biologics development at Sanofi. The Director of the Characterization team ... **Job Title:** Director Bioanalytics Characterization **Location:** Framingham, MA **About the...Bioanalytics group, which is part of the Global Biologics CMC Development organization at Sanofi, Framingham, MA. We are… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …role, you will build and oversee Global Regulatory Science and Regulatory CMC strategic framework and will support driving deliverables for the Regeneron Cell ... oversight to the development of innovative regulatory affairs and CMC regulatory strategies, guidance and play a critical role...and internal stakeholders. A typical day as an Executive Director might look like: + Responsible for the strategic… more
- Takeda Pharmaceuticals (Boston, MA)
- …Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that require ... as functional expert in divisional and cross-divisional initiatives. + Represents CMC on cross-divisional governance and development teams while providing strategy… more
- AbbVie (Worcester, MA)
- …and digital strategy, influencing and driving end-to-end digital integration within Biologics CMC . This leader will collaborate closely with IT partners to evaluate ... TensorFlow, PyTorch, or similar) that are relevant to biologics CMC workflows. + Demonstrated ability to leverage AI and...ability to leverage AI and ML techniques for biologics CMC development to optimize processes, improve data analysis, and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. + Implement… more
- Bayer (Cambridge, MA)
- …and diverse minds to make a real difference, there's only one choice.** ** Director R&D Reg Data Mgmt Expert DSAI** **YOUR TASKS AND RESPONSIBILITIES** The primary ... responsibilities of this role, Director , R&D Data Management Expert, DSAI are to: This...Standards Governance, 2. Direct and Indirect (eg, partnering with CMC , Labeling, etc.) execution activities that support Data-based Submissions… more