Analytical Scientist

OCUGEN OPCO INCEast Whiteland Township, PA
4dOnsite

About The Position

We are seeking a motivated Analytical Scientist to support analytical development for AAV gene therapy programs, with a primary focus on chromatography and analytical chemistry methods. This role will support development, optimization, and execution of chromatographic assays used for AAV vector characterization, impurity analysis, and process development support. The ideal candidate will have 2–3 years of industry experience working with AAV gene therapy products and hands-on experience with HPLC/UPLC-based analytical methods.

Requirements

  • MS or BS in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
  • 2–3 years of industry experience in AAV gene therapy or viral vector analytical development.
  • Hands-on experience with chromatographic techniques (HPLC/UPLC).
  • Experience with SEC, IEX, or reverse-phase chromatography.
  • Experience with chromatography data systems (e.g., Empower or OpenLab).
  • Strong understanding of analytical chemistry principles and assay troubleshooting.
  • Strong analytical thinking and problem-solving skills.
  • Ability to work effectively in a collaborative, fast-paced R&D environment.

Nice To Haves

  • Experience supporting AAV vector characterization.
  • Familiarity with method qualification or validation in a regulated environment.
  • Experience supporting CMC development programs for gene therapy products.

Responsibilities

  • Develop, optimize, and execute chromatographic methods (HPLC/UPLC) for AAV product characterization.
  • Support analytical methods used for purity, identity, and impurity profiling of AAV vectors.
  • Perform method optimization, troubleshooting, and robustness assessments.
  • Conduct analytical testing using techniques such as HPLC, UPLC, SEC, IEX, and RP chromatography.
  • Support characterization of AAV capsids, aggregates, and process-related impurities.
  • Generate high-quality analytical data to support process development, comparability, and stability studies.
  • Support analytical method qualification and transfer to QC laboratories.
  • Assist in preparing analytical protocols, reports, and technical documentation.
  • Analyze chromatographic data and summarize results in technical reports.
  • Maintain laboratory documentation in accordance with GxP and data integrity (ALCOA+) standards.
  • Provide analytical insights to support process and product development.
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