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 laboratory, strengthening internal capabilities and supporting long‑term commercial supply.
• Author and review Quality System documentation, including SOPs, Change Controls, and CAPAs, to support method implementation, lifecycle changes, and inspection readiness.
• Partner with Regulatory Affairs–CMC to author, review, and coordinate CMC sections of regulatory submissions, including specifications, method validation reports, and responses to agency queries.
• Ensure QC visibility and alignment on regulatory interactions, including tracking agency questions, commitments, post‑approval requirements, and method introduction or change strategies.
• Serve as a key QC technical interface across CMC, Quality, Regulatory, Manufacturing, Process Development, Analytical Research & Development, and external partners, providing clear guidance, alignment, and issue resolution to advance program milestones.

Qualifications:

• Advanced degree (MS, Ph.D) in Chemistry, Biochemistry, Molecular Biology, or a related scientific discipline, with 8+ years of relevant industry experience in Quality Control, Analytical Development, or CMC within biologics, cell therapy, or gene therapy.
• Extensive hands‑on experience with ex vivo autologous cell therapies, including CD34+ cell‑based products, across late‑stage development, validation, and/or commercial readiness.
• Demonstrated technical expertise in cell handling and testing methodologies, including functional and potency assays, flow cytometry, NGS‑based assays, and separation sciences. Experience with analytical method automation, qualification, and validation is strongly preferred.
• Proven understanding of analytical method lifecycle management, including method transfer, qualification, validation, performance monitoring, remediation, and comparability, particularly for late‑stage and commercial products.
• Strong working knowledge of US and EU regulatory expectations (e.g., FDA/CBER, EMA, ICH, USP) applicable to cell and gene therapy CMC, with the ability to apply guidance in a phase‑appropriate and inspection‑ready manner.
• Direct experience supporting regulatory submissions (INDs, BLAs, amendments, post‑approval changes) for cell and gene therapy products, including specifications, method validation reports, and responses to health authority questions.
• Demonstrated ability to lead and influence cross‑functional program teams, partnering effectively with CMC, Manufacturing, Analytical R&D, Quality Assurance, and Regulatory Affairs in a fast‑paced, matrixed environment.
• Strong communication and leadership skills, with a track record of clearly articulating technical strategies, aligning stakeholders, and driving decisions across functions and with external partners.
• Documented success in driving complex, program‑critical initiatives to completion on time and within budget, including managing dependencies, risks, and priorities across multiple workstreams.
• Highly developed organizational, analytical, and problem‑solving skills, with the ability to interpret complex datasets, assess risk, and translate data into actionable QC and CMC strategies.