- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee ... Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and manage regulatory… 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
- 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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Drug Substance Commercial Development **Location** : Cambridge, MA **About the Job** Are you ready to shape the future of ... progress. The Commercial Process Development team, part of the CMC Synthetics Platform within the Sanofi R&D organization, is...join our growing Commercial Process Development team as an Associate Director . Under the direction of the… 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** ... cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory, CMC or other drug development related function. Clinical Science experience… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to bring Better Health and a Brighter Future to people worldwide. As an Associate Director in Analytical Development, you will lead efforts to develop advanced ... Process Development, Regulatory, Quality, and external partners (CROs/CDMOs) to achieve CMC objectives and meet program timelines. + Represent Analytical Development… more
- AbbVie (Cambridge, MA)
- …to ensure an in-depth understanding of the science behind each of these opportunities. The Associate Director , Search & Evaluation will be a key member of the ... research, clinical development, Regulatory Affairs, Chemistry Manufacturing and Controls ( CMC )). + Experience with conducting due diligence exercises within a… more
- AbbVie (Worcester, MA)
- …strategic programs; including Brand Teams, New Product Introductions, Product Transfers, CMC , Global Strategic Sourcing, Due Diligence, Site Selection, and Approvals ... and Continuous Improvement. Provides support and interfaces directly/indirectly with the FDA, EMA, MHRA, ANVISA, MoH, etc. for pre-approval inspections. Qualifications + Bachelor's Degree in relevant Life Science or other technical required. Graduate degree… more
- Shuvel Digital (Boston, MA)
- …Has supervisory and developmental responsibilities within a functional area. The program director manages one or more projects or programs, may manage an operating ... Desired Relevant Certifications: + Project Management Professional (PMP) + Certified Associate in Project Management (CAPM) + Program Management Professional (PgMP)… more