Research Associate
Clinical Research Associate III
Company: Sanofi
1 Year
Framingham,MA
Max PR:$27 - $30.65/hr
Responsibilties:
The incumbent will join a dynamic multi-disciplinary multi-modality drug product development team, with responsibilities that span from formulation development to fill finish of clinical, commercial and life-cycle stage assets within the Biologics/GMU Drug Product Development and Manufacturing.
The successful candidate would be required to:
o Develop experimental plans and execute studies to assess physicochemical stability of non-viral, viral vectors- and cell-based therapeutics
o Assist in process development studies for manufacturing unit operations for injectable dosage forms (e.g. freeze-thaw, mixing, filtration, filling, lyophilization etc.).
Assist in developing new technologies in the areas of polymer-based drug delivery technologies
o Work closely and independently with counterparts from other functional areas to deliver on CMC milestones
o Generate, document and compile data for team and senior management discussions and draft development reports
o Mentor junior staff as required
Education & Qualifications
- BS in Chemical Engineering, Pharmaceutical Science, Analytical Chemistry, Biochemistry, Biology (or related discipline)
Preferred Qualifications
- Solid understanding and practical experience in drug product formulation and process development of non-viral gene therapeutics: formulation development of lipid nanoparticles, liposomes and polymer conjugates for nucleic acid delivery, container closure selection, stability studies, in-use studies and process development of liquid, frozen, and lyophilized drug product.
- Theoretical knowledge and hands-on experience in analytical techniques: Fluorescence based nucleic acid quantitation assays (e.g. Ribogreen assay), HPLC/UPLC, capillary electrophoresis, gel electrophoresis, DLS, zeta-potential, DSC, DSF, UV, CD, Cryo-TEM.
- Experience in formulation and process development of viral vector-and cell-based therapeutics is a plus.
- Experience in cell culture, flow-cytometry, qPCR, ITA, plate-based potency assay is a plus.
- Basic understanding of statistical data analysis. Good written and verbal communication skills.