Our Gene Therapy Client in Cambridge, MA is looking to add a Principal Research Associate to their Analytical Development team! This role will perform assay development, optimization, work with partner CDMO’s and support assay qualification and validation. Will work with CDMO’s to generate data to support formulation studies, stability studies, and characterization of critical components, drug substance and/or drug products. Other responsibilities include but not limited to:
- Support testing of reference standards, lead stability samples, forced stability samples, toxicology lots, engineering runs, and clinical manufacturing runs, as appropriate.
- Cross-train personnel on assays, as required, and provide guidance to junior research associates.
- Support the preparation of regulatory filings, such as INDs, by providing technical information on analytical methods.
- Document all experimental work, supporting information, and data in an electronic lab notebook in a timely manner.
- Compile and present data to program teams.
- Author and review test methods, technical reports, and supporting procedures.
Our preferred candidate will have:
- Bachelor’s in a life science discipline with 8+ years of relevant analytical development, technical transfer, and quality control experience or a Master’s with 5+ years of relevant experience.
- Experience with various plasmid and AAV analytical methods. (Biophysical, bioassay, and molecular assay techniques such as CE-SDS, HPLC methods, Analytical ultracentrifugation, ddPCR / qPCR and design and development of potency assays specifically the AAV infectious titer assay). Expertise in molecular biology is required.
- Knowledge of protein biochemistry, techniques like the ELISA.
- Knowledge of CRISPR/Cas9 gene editing technologies.
- Knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles for CGMP operations.
- Preference for those who have working knowledge of protein biochemistry (ELISA), CRISPR/Cas9 gene editing technologies and FDA, EMA and ICH regulations, industry standards and quality control principles for CGMP operations.