Scientist, Analytical Development and Quality Control

Flagship Pioneering•Cambridge, MA

11d•$100,000 - $143,000

About The Position

FL87, Inc. is a privately held, early-stage biotechnology company developing a novel approach to gene therapy that can address currently untreatable diseases. FL87 was founded by Flagship Pioneering, an innovation enterprise that conceives, creates, resources, and grows first-in-category life sciences companies. Flagship Pioneering has created over 100 groundbreaking companies over the past twenty years, all of which are pioneering novel and proprietary biological, industrial, and engineering approaches to solve major needs in human health and sustainability. These companies include Moderna (MRNA), Syros Pharmaceuticals (SYRS), Seres Therapeutics (NASDAQ:MCRB), Generate Biomedicines, Tessera Tx, Evelo Biosciences (EVLO), and Indigo Agriculture. We are searching for an experienced and enthusiastic Scientist I/ II, Analytical Development and Quality Control to lead the development of novel methods to characterize novel nucleic acid therapeutics. We are looking for an individual who enjoys hands-on laboratory benchwork and brings scientific rigor and intellectual curiosity to their role. This individual will have the opportunity to work in a dynamic and fast-paced entrepreneurial environment as part of a highly collaborative and rapidly growing team.

Requirements

PhD (1+ years) or M.S. (8+ years) in Analytical Chemistry, Biochemistry, or related field.
Demonstrated in-depth expertise in HPLC, including method development, troubleshooting, system suitability design, chromatographic theory, and data interpretation.
Hands-on experience with multiple chromatographic techniques (RP-HPLC, SEC, IEX, affinity, gradient optimization, detector setup/maintenance).
Proven success developing and validating GMP analytical methods and supporting GMP operations.
Experience working in a QC or cGMP laboratory environment with strong understanding of data integrity requirements (
Strong communication, team leadership, and interpersonal skills.
Track record of working effectively in a multidisciplinary environment, interacting with teams from other line functions.
Strong organizational skills, precision in documentation, and ability to manage multiple analytical workflows simultaneously.
Ability to thrive in a fast-paced, multidisciplinary, and rapidly growing biotech environment.

Nice To Haves

Experience with complementary analytical techniques such as UV-Vis, LC-MS, CE, ELISA, or other functional assays is beneficial.

Responsibilities

Work with the team to drive advancement of platform development and play a vital role in shaping our analytical capabilities.
Step into benchwork to execute platform goals with tenacity, agility, and timeliness.
Lead the design, development, optimization, and execution of 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, with a strong emphasis on chromatographic workflows.
Serve as Subject Matter Expert for chromatography methods during investigations of deviations, OOS/OOT events, assay failures, and other non-conformance issues.
Provide technical leadership in HPLC troubleshooting, instrument maintenance coordination, data integrity practices, and chromatographic data review.
Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
Collaborate effectively with QC, Manufacturing, and Process Development teams to enable program success across phases.
Analyze, troubleshoot, and communicate experimental findings clearly and succinctly in oral, written, and visual formats.
Work independently and collaboratively in a multidisciplinary team environment.