Sr. Director, QC Microbiology

Company Overview

Beam Therapeutics is developing precision genetic medicines through the use of base editing. Beam’s proprietary base editors create precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This enables 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. Our dream is to provide life-long cures for patients suffering from serious diseases.

The Beam Team Is:

• A community of fearless innovators
• Rigorous and honest in our research
• Listening with open minds
• Committed to each other

Position Overview:

The Senior Director, Quality Control (QC), Microbiology will lead the strategy, execution, and oversight of key QC functions, including sample management, environmental monitoring, contamination and aseptic control, microbiology testing, raw materials qualification and testing, analytical instrument qualification, and pre-license inspection (PLI) readiness activities. This role is pivotal to shaping the overall facility strategy and driving the growth of the Quality organization at the North Carolina (NC) site.

The NC manufacturing facility specializes in advanced therapeutic technologies, including cell and gene therapy modalities. It currently operates as a clinical-phase manufacturing plant with plans to transition multiple programs to commercial production within the same facility.

This position places a strong emphasis on contamination control, aseptic processing, and environmental monitoring/microbiology to ensure robust systems and processes that maintain compliance with Good Manufacturing Practices (GMP). The Senior Director will report directly to the Vice President, Quality Control.

Primary Responsibilities:

• Strategic Leadership: Develop and implement the overall QC strategic plan to support site and organizational objectives.
• Management: Lead a diverse team of subject matter experts in microbiology, raw materials, and analytical instrument qualification.
• Contamination Control: Own and manage the facility’s contamination and aseptic control programs.
• Environmental Monitoring: Design and oversee the execution of the site’s environmental monitoring program.
• Microbiology & Sterility Testing: Define and implement sterility and biological testing/validation requirements for cell and gene therapy products in alignment with industry standards.
• Raw materials: Design and oversee the execution of the raw materials testing strategy including materials categorization, risk assessments, method qualification, and testing.
• Testing Oversight: Ensure timely, accurate raw material, in-process, and final product release testing.
• Sample Management: Oversee sample control processes, including retain management.
• Compliance: Ensure adherence to cGMP principles within internal and external laboratories.
• Documentation & Review: Manage internal and external cGMP labs by reviewing and approving SOPs, protocols, reports, test methods, change requests, technical transfers, and OOS investigations.
• Resource Allocation: Ensure projects have appropriate QC resources to meet timelines and deliverables.
• Continuous Improvement: Drive continuous improvement initiatives in QC processes, systems, and technologies to enhance efficiency and compliance.
• Compliance: Maintain QC systems and equipment in compliance with guidelines and data integrity principles including collaborating cross-functionally on analytical instrument qualification and associated software tool validation strategy
• PLI Readiness: Build appropriate processes, systems, and training in preparation to support PLI inspections as well as continued external audits by regulators
• Data Management: Track and trend cGMP data and compile reports for management reviews, Annual Product Reviews, and other required assessments.
• Team Development: Foster a culture of continuous improvement within the QC organization.

Embodies Beam’s cultural values and aligns daily actions with departmental goals and company culture.

Qualifications:

• Education: