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Research Associate, Drug Product Analytical Development
Ref No.: 18-09718
Location: Cambridge, Massachusetts
Start Date: 08/06/2018
The primary responsibilities of this contract role will be to support development and conduct of analytical methods for messenger RNA therapeutic drug products. The incumbent will be expected to undertake laboratory work to support testing and data collation for internal release and stability studies. The role will also require the individual to work with external contract research organizations (CRO's) or contract manufacturing organizations (CMO's) to transfer methods and monitor the progress of placed work.

Additional responsibilities include developing methods for drug product components and drug product in-process tests, characterization of impurities, and qualification of analytical methods. This position will support cross-functional teams in Research and Development, Production and Quality.

Here's What You'll Do:
  • Undertake analytical testing using established methods to generate high quality data to support internal release and supporting stability studies.
  • Develop methods in collaboration with supervisor and perform verification and validation experiments.
  • Write analytical method SOP's and train personnel on methods as needed.
  • Qualify methods and transfer to / from contract organizations.
  • Provide summary presentations and detailed reports to internal and external stake holders.
  • Maintain and troubleshoot equipment performance as needed.

Here's What You'll Bring to the Table:
  • BS with 3 years or MS with 2 years of relevant industry or undergraduate experience in analytical chemistry.
  • BS/MS in Analytical Chemistry, Biochemistry, Chemical Engineering, or closely related field.
  • Knowledge of HPLC and modes of separation (e.g. ion exchange, reverse phase ion pair, size exclusion).
  • Knowledge of equipment platforms (e.g. Thermo, Waters, Agilent) and data processing software (e.g. Chromeleon, Chemstation, Empower).
  • Knowledge of nucleic acid chemistry and biology and standard methods of analysis of these molecules.
  • Proven track record for managing method transfers and qualifications at external CMOs/CRO's.
  • Hands on industry experience with analytical development for RNA and DNA therapeutics
Knowledge of GMP and GLP regulations and guidance on analytical method validation (ICH Q2 (R1)