Senior Quality Control Specialist

7 days ago


Cambridge, Massachusetts, United States Beam Therapeutics Inc. Full time
Job Summary

The Quality Control Specialist will support critical analytical method implementation workstreams in support of GMP testing laboratory start-up plan. This role will serve as a Subject Matter Expert in the quality control group and lead the training efforts, method transfers from external CDMO, Analytical R&D to QC group.

Key Responsibilities
  • Maintain QC laboratory including instrument calibration, PMs, and operational SOPs
  • Perform Release Testing, Qualification, Validation and Method Transfer for various cell therapy methods
  • Perform stability testing, assist, keep records of stability sample pulls, and write/revise stability protocols
  • Train junior QC Analysts
  • Collaborate with multiple departments for on-time completion of variety of analyses
  • Process improvement for a faster turnaround time, OTIF (on-time in full) completion of projects
  • Prepare the data packet for review and peer-review the data
  • Maintain stability sample inventory and perform stability sample shipments to external contract laboratories and/or sample storage vendors
  • Support stability data analysis along with stability document reviews
  • Track and order laboratory reagents and materials
  • Sample receiving per the BEAM-SOP guideline
  • Oversee general cleaning and upkeep of the laboratory and equipment
Requirements
  • Bachelor's degree required, preferably in a chemistry, life science, or related discipline
  • 10+ years relevant experience
  • Prior GMP experience
  • Hands-on experience on with at least one of the following analyses: mRNA, LNP, CFU, Potency assay, gRNA, NGS assay, Flow Cytometry, PCR, ELISA, and/or Multiplex
  • Hands-on experience with HPLC (DAD-CAD, UV-ViS), UHPLC, and/or Mass-Specs preferred
  • Result-oriented and ability to prioritize complex issues
  • Prior knowledge of LIMS, VEEVA, and/or KNEAT preferred
  • Scientific knowledge and direct experience with analytical method transfer processes
  • Advanced technical writing skills and problem-solving ability
  • Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
  • Collaborative with 'Team First' mentality
  • Communicate effectively with peers, and demonstrate collaboration across different functional groups

Beam Therapeutics Inc.



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