- 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... ensure compliance with applicable regulations and guidelines. + Provide CMC functional representation on wider cross-functional program development teams, ensuring… 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)
- …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 (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
- Humana (Boston, MA)
- …mitigate risks. The Senior Clinical Compliance Professional will support the Director of Compliance, by ensuring compliance with governmental requirements for ... pharmacy knowledge a plus + Certified Coder (CPC, CRC, and/or CMC ) + Experience with metrics and reporting **Additional Information** **Work-At-Home Requirements:**… 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