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Contract Quality Control Research Associate

Contract Quality Control Research Associate

Lexeo TherapeuticsNew York, NY, US
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Contract Quality Control Research Associate

The Contract QC Research Associate will support the CMC Quality Control (QC) function by coordinating all aspects of sample management (including, but not limited to : storage, documentation, submission, and shipment) to internal and external testing laboratories. This role ensures timely and accurate execution of sample testing activities to support product release, stability programs, and other analytical requirements. Additionally, this role will help organize, trend, interpret, and summarize the data resulting from testing.

Responsibilities

  • Serve as primary contact for QC Lab Support processes such as laboratory inventory management, sample submission, sample receiving.
  • Prepare and manage sample submission paperwork for external contract testing labs (CTLs), including quotes, purchase orders, shipping documents.
  • Coordinate shipment of samples, reference standards, and reagents to and from manufacturing sites, external vendors, and CTLs in compliance with storage and shipping requirements.
  • Track sample testing from submission through completion; receive and organize Certificates of Analysis (CoAs), Certificates of Testing (CoTs), and other QC data packages.
  • Coordinate with vendors and support vendor testing activities by ensuring report documentation packages are complete and organized.
  • Configure and maintain the LIMS system to support controlled temperature unit (CTU) inventory and sample tracking requirements.
  • Enter and manage sample data in LIMS; ensure accurate labeling, categorization, and documentation.
  • Generate sample labels with unique identifiers (e.g., barcodes or QR codes) and ensure physical organization of samples in alignment with electronic records.
  • Collaborate with cross-functional CMC teams to align on sample submission and testing needs.

Required Skills & Qualifications

  • Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Biotechnology).
  • Hands on experience in pharmaceutical / biotech QC, sample management, or logistics with an understanding of lab safety; knowledge of IATA RCA and DOT guidelines a plus.
  • Experience with LIMS and laboratory sample tracking systems; familiarity with Benchling or Quartzya is a plus.
  • Strong organizational skills with attention to detail and accuracy.
  • Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
  • Excellent communication and coordination skills.
  • Knowledge of GMP / GxP requirements for sample handling, testing, and documentation preferred.
  • About Lexeo

    Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer's disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of clinical and preclinical programs. Lexeo successfully completed a $112M IPO in November 2023 and in early March 2024 announced a PIPE raising an additional $95M, extending the Company's runway into 2027.

    Our work culture for most roles is a hybrid model with days in the New York City office and days working from home. We welcome applications from candidates located across the Northeast and Mid-Atlantic. Remote work can be considered for exceptional candidates.

    Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.

    Additional

    Location : New York, NY

    J-18808-Ljbffr

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