About the job
FL87, Inc. is an innovative, privately held biotechnology company at the forefront of gene therapy development, dedicated to tackling previously untreatable diseases.
Founded by Flagship Pioneering, a leading innovation enterprise, FL87 benefits from a legacy of creating and nurturing pioneering life sciences companies. Over the past two decades, Flagship Pioneering has established more than 100 groundbreaking companies, including renowned names like Moderna, Syros Pharmaceuticals, and Evelo Biosciences, all working to address critical challenges in human health and sustainability.
Position Overview:
We are on the lookout for a passionate and skilled Scientist I/II in Analytical Development and Quality Control. This role entails leading the innovation of analytical methods for characterizing cutting-edge nucleic acid therapeutics. Ideal candidates will thrive in a hands-on laboratory environment and bring both scientific rigor and intellectual curiosity to our collaborative team.
Key Responsibilities:
- Collaborate with the team to propel platform advancements and enhance analytical capabilities, demonstrating determination and agility in achieving platform goals.
- Design, develop, optimize, and execute HPLC-based analytical methods (e.g., RP-HPLC, SEC, IEX) to support in-process, release, and stability testing.
- Develop, qualify, validate, and characterize GMP-compliant purity, SEC, and content methods for intermediates and drug products, focusing on chromatographic workflows.
- Act as a Subject Matter Expert for chromatography methods during investigations of deviations, OOS/OOT occurrences, assay failures, and other non-conformance issues.
- Provide technical leadership in HPLC troubleshooting, instrument maintenance coordination, data integrity practices, and chromatographic data review.
- Ensure meticulous laboratory documentation and maintain audit-ready analytical records.
- Work collaboratively with QC, Manufacturing, and Process Development teams to drive program success across various phases.
- Analyze, troubleshoot, and communicate experimental results clearly and effectively in oral, written, and visual formats.
- Demonstrate both independent and collaborative problem-solving skills in a fast-paced environment.

