Quality Control Specialist II

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:

We are seeking a QC Specialist with experience in technical transfer, qualification, validation and GMP testing of separations and biophysical based assays for mRNA and lipid nanoparticle manufactured materials. This contributor will be responsible for the execution of complex experiments in a GMP environment.  The ideal candidate will be independent and detail oriented, previous experience in design and development of functional cell-based assays, work collaboratively with cross-functional teams, and have a working knowledge of ICH/USP guidelines and potency matrix/assurance strategies.  

Responsibilities:

• Optimize, technical transfer, qualification, and validation of separations and biophysical methods for mRNA and LNP products.
• Execution of assays utilizing various analytical techniques such as (IPRP, SEC, IEX), capillary gel electrophoresis, fluorescence-based RNA quantitation. Experience with qPCR, DNA and RNA extraction, ELISA, western blotting, UV spectrophotometry, DLS, MALS, mass spectrometry, and compendial testing will be a plus.
• Author and review SOPs and technical reports.
• Acting as an SME resource to external partners.
• Work with cross-functional groups including Research & Development, Analytical Development, and Process Development teams to participate in various aspects of method development, transfer, process and product characterization, comparability, and investigations.
• Analyze, track, and trend data to monitor analytical assays and ensure consistency in assay performance.

Qualifications:

• Master’s degree with 8+ years of relevant experience or bachelor’s with 10+ years of experience.
• Experience of executing analytical method transfer, qualification, and validation for mRNA and LNP products.
• Extensive experience with several of the following analytical techniques is required: HPLC (IPRP, SEC, IEX), capillary gel electrophoresis, fluorescence-based RNA quantitation. Experience with qPCR, DNA and RNA extraction, ELISA, western blotting, UV spectrophotometry, DLS, MALS, mass spectrometry, and compendial testing will be a plus.
• Experience using data analysis software including JMP and PLA software.
• Knowledge of ICH/USP guidelines.
• Proven track record of functional and potency assay technical transfer, qualification, and validation in a GMP laboratory.
• Ability to critically think though experimental challenges and troubleshoot.
• Team player with excellent oral and written communication skills.
• Independently motivated, detail-oriented, and excellent problem-solving abilities.
• Domestic and international travel may be required to external CTLs and other Beam sites.