- Lilly (Boston, MA)
- …Director, Regulatory CMC to lead and execute regulatory CMC strategies for our cutting-edge gene therapy portfolio. This role will be critical in shaping the ... Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA, BLA/MAA, and post-approval… more
- ThermoFisher Scientific (Waltham, MA)
- …trends relating to pharmaceutical product development in the area of cell and gene therapy . + Lead maintenance and improvements to regulatory tools, including ... and other regions, particularly concerning pharmaceutical raw materials and cell and gene therapies, and their influence on the product development process. +… more
- ThermoFisher Scientific (Andover, MA)
- …When you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities ... that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world. **Location/Division Specific… more
- Bristol Myers Squibb (Devens, MA)
- …in a relevant discipline. + Experience delivering IT solutions for advanced therapy manufacturing/laboratories (cell, gene therapy , biologics). + Knowledge ... a production line to the latest breakthroughs in cell therapy , this is work that transforms the lives of...Senior Manager, Benchtop IT Systems at the Devens Cell Therapy Facility is responsible for leading the design, deployment,… more
- Sanofi Group (Cambridge, MA)
- …2026. This internship will focus on statistical challenges and advanced methodologies in gene therapy clinical trials, a rapidly evolving field with unique ... in literature review, case study analysis of an FDA or EMA-approved gene therapy , and exploration of advanced statistical techniques relevant to rare disease and… more
- Danaher Corporation (Boston, MA)
- …fluency sufficient to engage credibly with academic and industry researchers in areas such as viral gene therapy , gene modified cell therapy , gene ... sales process + Experience (academic or professional) with Cell & Gene Therapy modalities + Experience with drug development process (from discovery through… more
- Lilly (Boston, MA)
- …Experience creating and submitting CTA/IND and BLA/MAA filings for complex biologics or gene therapy products. + Strong knowledge of current Good Manufacturing ... biologics development regulations and guidelines including FDA and EMA guidelines for gene therapy and biologic products. + Ability to collaborate and work in a… more
- ThermoFisher Scientific (Plainville, MA)
- … therapies. Placed in the forefront of our leading- and innovative Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise ... gene therapies. We are at the forefront of our Cell and Gene Therapy business, enabling clients to cure genetic, rare, and untreatable diseases. **How will… more
- Lilly (Boston, MA)
- …in the discovery and clinical development of genetic medicines, including siRNAs, ASOs, mRNAs, gene editing, and gene therapy . We are committed to advancing ... Skills/Preferences:** + Knowledge of DMPK and/or bioanalytical considerations for gene editing therapeutics + Experience with PK/PD modeling and simulation… more
- ThermoFisher Scientific (Plainville, MA)
- …Fisher Scientific Viral Vector Services (VVS), is a rapidly growing, dynamic gene therapy contract development and manufacturing organization. Our employees are ... Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy business, we enable clients to cure genetic, rare, and otherwise untreatable… more