Beam Therapeutics · 5 hours ago
Sr. Director, QC Microbiology
Durham, NC
Full-time
Onsite
Director/Executive
$250K/yr - $310K/yr
12+ years expBeam Therapeutics is a biotechnology company focused on precision genetic medicines. The Senior Director, Quality Control (QC), Microbiology will lead the strategy and execution of key QC functions to ensure compliance with Good Manufacturing Practices (GMP) and support the growth of the Quality organization at the North Carolina site.
BiotechnologyGeneticsMedicalTherapeutics
Responsibilities
Develop and implement the overall QC strategic plan to support site and organizational objectives
Lead a diverse team of subject matter experts in microbiology, raw materials, and analytical instrument qualification
Own and manage the facility’s contamination and aseptic control programs
Design and oversee the execution of the site’s environmental monitoring program
Define and implement sterility and biological testing/validation requirements for cell and gene therapy products in alignment with industry standards
Design and oversee the execution of the raw materials testing strategy including materials categorization, risk assessments, method qualification, and testing
Ensure timely, accurate raw material, in-process, and final product release testing
Oversee sample control processes, including retain management
Ensure adherence to cGMP principles within internal and external laboratories
Manage internal and external cGMP labs by reviewing and approving SOPs, protocols, reports, test methods, change requests, technical transfers, and OOS investigations
Ensure projects have appropriate QC resources to meet timelines and deliverables
Drive continuous improvement initiatives in QC processes, systems, and technologies to enhance efficiency and 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
Build appropriate processes, systems, and training in preparation to support PLI inspections as well as continued external audits by regulators
Track and trend cGMP data and compile reports for management reviews, Annual Product Reviews, and other required assessments
Foster a culture of continuous improvement within the QC organization
Qualification
Required
Bachelor's or advanced degree in a scientific discipline
Minimum of 12 years in the pharmaceutical or biotech industry, encompassing drug substance/drug product manufacturing, development, and/or quality
Strong preference for direct experience in cell and/or gene therapy manufacturing environments
Proven experience leading teams within Quality and Quality Control functions, with emphasis on contamination control, microbiology, and raw material testing
At least 5 years of experience in Quality management roles
Demonstrated experience interacting with regulatory health authorities during pre- and post-approval inspections
Solid understanding of global regulations, cGMP principles, and industry standards
Excellent verbal and written communication abilities, with strong attention to detail and capability to influence and drive change across functions
Strong team player with a customer-focused, solution-oriented mindset; able to work independently, within cross-functional teams, and with external partners and vendors
Exceptional team-building, leadership, and interpersonal skills that foster collaboration and team spirit
Consistent track record of delivering high-quality work and meeting corporate objectives
Skilled in managing vendors and external partners involved in Quality and Regulatory activities
Ability to gown and enter GMP cleanroom environments
Benefits
Relocation assistance is available for qualified candidates.
Company
Beam Therapeutics
Beam Therapeutics is a biotechnology company developing precision genetic medicines through the use of base editing technology.
501-1000 employees
H1B Sponsorship
Beam Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (12)
2022 (9)
2021 (7)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.19B2025-03-10Post Ipo Equity· $500M
2021-01-19Post Ipo Equity· $260M
2020-02-11Post Ipo Equity· $207M
Leadership Team
John Evans
CEO
Christine Bellon
Chief Legal Officer
Recent News
2026-01-23
2026-01-13
Company data provided by crunchbase