Principal Research Associate, Molecular Analytical Development
Editas Medicine, United States

Key Responsibilities amp; Accountabilities:

• Work collaboratively with research to transfer assays into AD.
• Develop and optimize quantitative real-time PCR assays. Perform initial method qualifications.
• Develop and optimize cell-based assays with ddPCR readout. Perform initial method qualifications.
• Collaborate with Process Development to generate data to support formulation studies, stability studies, and characterization of nuclease protein and guide RNA /protein complexes.
• Support testing of reference standards, lead stability samples, forced degradation samples, toxicology lots, non-human use (NHU) engineering runs, and clinical manufacturing runs.
• Document all experimental work, supporting information, and data in an electronic lab notebook (eLN) in a timely manner. Ensure direct reports complete eLN entries in a timely manner.
• Author and review test methods, technical reports, and supporting procedures.
• Assist in the technical transfer of assays to Quality Control or central testing laboratories, including providing technical support for assay qualification and validation efforts.
• Cross-train personnel on assays, as required, and provide guidance to junior research associates which will include managing a small team of junior research associates.
• Support the preparation of regulatory filings, such as INDs, by providing technical information on analytical methods.
• Compile and present data to program teams.
• Other responsibilities as required.

Requirements

Knowledge, Skills amp; Capabilities:

• (Minimum) 3+ years experience with developing molecular assays, including quantitative real-time PCR assays and droplet digital PCR (ddPCR) assays.
• (Minimum) Experience with mammalian cell culture.
• (Minimum) Strong organizational skills with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment.
• (Minimum) Strong verbal and written communication skills.
• (Minimum) Strong leadership skills.
• (Preferred) Experience developing, optimizing, and qualifying cell-based or biochemical potency assays for biologics.
• (Preferred) Experience with technical transfer of GMP test methods for biologics.
• (Preferred) Knowledge of CRISPR/Cas9 gene editing technologies.
• (Preferred) Knowledge of FDA, EMA, and ICH regulations, industry standards and quality control principles for cGMP operations.

Education amp; Relevant Work Experience:

• (Minimum) Bachelor’s in a life science discipline such as Biological Sciences, Biotechnology, Pharmaceutical Sceinces, or Biomedical Engineering with 8+ years of relevant analytical development, technical transfer, and quality control experience or a Master’s with 4+ years of experience.

Job Rewards and Benefits