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Associate Director, Quality Control Technical Services
Job in
Cambridge, Middlesex County, Massachusetts, 02138, USA
Listed on 2026-06-03
Listing for:
Beam Therapeutics Inc.
Full Time
position Listed on 2026-06-03
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst -
Healthcare
Data Scientist
Job Description & How to Apply Below
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and 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 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 an Associate Director, Quality Control Technical Services to lead QC CMC strategy for our ex vivo cell therapy franchise, spanning late-stage development, initial commercial launch, and ongoing lifecycle management. This role will also play a critical leadership role in defining and executing the strategy for mRNA drug substance and critical materials platforming, supporting both current programs and future pipeline scalability.
The successful candidate will work cross‑functionally with Analytical Research & Development, Bioprocess Development, Manufacturing Technical Services, Manufacturing Operations, Regulatory Affairs, and Quality Assurance to drive the transfer, qualification, validation, and lifecycle management of analytical methods for gene‑edited cell therapy products and associated critical materials (e.g., mRNA). These efforts will ensure analytical readiness to support regulatory submissions, agency approvals, and commercial supply.
This role will be instrumental in defining the QC testing and technical transfer strategy for next‑generation autologous cell therapy manufacturing, including the transfer of automated and validated analytical methods to Beam's internal manufacturing facility. A key focus will be the internalization of validated mRNA methods into the North Carolina Quality Control laboratory, strengthening in‑house testing capabilities and long‑term operational resilience.
In addition, this position will contribute directly to regulatory filings, including specifications, analytical method validation reports, and CMC documentation, and will serve as a QC technical subject matter expert across program teams to ensure compliant, robust, and phase‑appropriate analytical strategies.
Primary Responsibilities:
* Lead and influence QC CMC strategy in partnership with cross‑functional CMC teams for master cell banks (MCBs), plasmids, and mRNA drug substance and critical materials, supporting both ex vivo and in vivo therapy programs across development and commercialization.
* Define and execute the QC testing, method strategy, and technical execution to enable next‑generation autologous cell therapy manufacturing processes, including analytical readiness for process validation, comparability, and technology transfer.
* Own and coordinate analytical method transfer, qualification, and validation activities across internal and external QC laboratories, ensuring compliant, phase‑appropriate, and inspection‑ready execution.
* Establish and maintain analytical control strategies by tracking and trending in‑process, release, and stability data, collaborating with statisticians and program teams to define and justify specifications for MCBs, plasmids, mRNA, and autologous cell therapy products.
* Define and oversee stability strategies and programs for MCBs, plasmids, mRNA, and ex vivo cell therapy products, ensuring alignment with regulatory expectations and lifecycle needs.
* Lead analytical method lifecycle management for late‑stage and commercial ex vivo portfolio, including method performance monitoring, remediation, comparability activities, and continuous improvement.
* Drive the internalization of validated mRNA analytical methods into Beam's North Carolina Quality Control…
Position Requirements
10+ Years
work experience
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