Beam Therapeutics is seeking a Sr. Director, QC Microbiology to 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 readiness activities.
Requirements
- 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.
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Tuition Reimbursement
- Relocation Assistance
