Beam Therapeutics

Beam Therapeutics

Associate Director, Quality Control Technical Services

Cambridge, MA · Director · Full-time

Sponsorship not specified$185k-$225kDetected 71 days ago
FDA RegulatoryCRISPRFlow CytometryMolecular BiologyNGSResearchAnimal StudiesLeadershipCommunicationRegulatory Affairs

About the role

  • 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.
  • 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.

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.
  • 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.
  • 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.
  • 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.
  • These efforts will ensure analytical readiness to support regulatory submissions, agency approvals, and commercial supply.

Requirements

  • Extensive hands‑on experience with ex vivo autologous cell therapies, including CD34+ cell‑based products, across late‑stage development, validation, and/or commercial readiness.
  • 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.
  • 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.
  • 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.
  • The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.
  • Beam Pay Range

Nice to have

  • 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.

Compensation

  • The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.

Benefits

  • 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.

Company info

  • 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.
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