Principal Research Associate
Responsibilities of the Principal Research Associate:
- Work collaboratively cross functionally with internal project teams, with external partners and with CDMOs to design, transfer & troubleshoot analytical methods primarily for plasmids and AAVs. Provide technical support for assay qualification and validation.
- Independently perform assay development and optimization.
- Collaborate with PD & external CDMOs to generate data to support formulation studies, stability studies, and characterization of critical components, drug substance and/or drug product.
- 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.
- 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.
- Other responsibilities as assigned.
Requirements of the Principal Research Associate:
- Bachelor’s in a life science discipline such as Biological Sciences, Biotechnology, Pharmaceutical Sciences, or Biomedical Engineering with 5+ years of relevant analytical development, technical transfer, and quality control experience or a Master’s with 2+ years of relevant experience.
- Experience with various plasmid and AAV analytical methods. This includes 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.
- Strong organizational skills with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment.
- Strong verbal and written communication skills.
- Knowledge of protein biochemistry, techniques like the ELISA.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.