Associate Scientist, Analytical Development

The Associate Scientist, Analytical Development, will support the development, qualification and execution of analytical assays for in-process analytics, process development and non-clinical recombinant adeno-associated virus (rAAV) vector manufacturing. This individual provides analytical test methods development, qualification and validation support for future non-GMP drug product release.

Responsibilities and Accountabilities

  • Support design and development of capillary electrophoresis (CE)-based viral separation and quantitation methods
  • Develop ELISA-based viral quantitation assays for impurities in viral AAV products
  • Develop methods for biophysical protein analysis methods, such as DLS, aggregates and particulates in drug product
  • Provide analytical testing support for process development, R&D and external CMO teams to assist in the development and analytical characterization of new therapeutic targets
  • Support/execute qualification/validation of developed analytical methods and tech transfer the methods to partner CMO
  • Author development reports, study protocols, SOPs and pre-validation reports
  • Contribute to technical discussions and investigations within the Analytical group and help support process development and non-clinical manufacturing
  • Detailed, organized, formal record keeping through lab notebooks
  • Excellent communication skills and works well in a small group work environment

About you: 

  • BS or MS in bioanalytical chemistry, biology, biochemistry, virology or related field with at least 1-4 years’ experience
  • Demonstrated experience in development of various analytical assays including CE, DLS, MFI, qPCR, ELISA, AUC, etc.
  • Proven ability to work in a fast-paced environment, meet deadlines and prioritize work on multiple projects. Strong attention to detail with the ability to handle multiple responsibilities simultaneously
  • Must be able to support generating high-quality data for presentations and publications
  • Excellent interpersonal skills with the ability to interact effectively with people, internally and externally is required
  • Must be self-motivated, organized, capable of working independently, as well as follow directions in a collaborative/group environment
  • Possess strong oral and written communication skills
  • Must exhibit strong troubleshooting skills with minimal supervision
  • Good judgment and innovation to achieve a solution within standard practices and procedures
  • Experience with global teams, especially Spanish speaking, a plus
  • Must have a valid passport and able to physically travel to, including but not limited to, international and remote locations
  • Must be able to tolerate normal office climatic conditions associated with daily activities