Specialist, Quality Control

2 days ago

Cambridge, United States Beam Therapeutics Inc. Full time
Company Overview:

Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview

The Quality Control Specialist, as a Subject Matter Expert (SME), will support critical analytical method implementation workstreams in support of GMP testing laboratory start-up plan. The person will serve as a Subject Matter Expert in the in the quality control group and will lead the training efforts, method transfers from external CDMO, Analytical R&D to QC group. The workstreams include technical GMP lead for release and stability testing, analytical instrument qualification check, instrument troubleshooting and maintenance supervision, assisting in critical reagent management, execution of technical protocols, and supporting the implementation of programs and procedures in a new Quality Control laboratory located in Cambridge, Massachusetts.

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
  • Training 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
  • Tracking and ordering of laboratory reagents and materials
  • Sample receiving per the BEAM-SOP guideline
  • Oversee general cleaning and upkeep of the laboratory and equipment
  • Result-oriented and ability to prioritize complex issues
  • Analyze data; interpretation of data within given parameters
  • Datasheet review, QC investigation, out of specification (OOS), CAPA, Change Controls, and/or Deviation report writing experiences desired
  • Prior knowledge of LIMS, VEEVA, and/or KNEAT preferred.
  • Independently develop, author, revise, and execute SOPs, protocols, reports, and other related documents
Qualifications:
  • 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

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