What are the responsibilities and job description for the Director of Quality Control position at Metric Bio?
metric Bio is currently partnered with a rapidly growing, private equity-backed Cell & Gene Therapy CDMO seeking a Director of Quality Control to lead both QC Analytical and QC Microbiology functions at its Indiana facility.
This is a highly visible leadership role within an organization experiencing significant organic and acquisitive growth. The successful candidate will serve as the face of the QC organization, partnering with clients, regulatory agencies, and internal stakeholders to ensure the highest standards of quality, compliance, and operational excellence.
Key Responsibilities:
- Lead and develop QC Analytical and QC Microbiology teams
- Oversee release, in-process, stability, and environmental monitoring programs
- Provide technical leadership for analytical methods including ELISA, qPCR, ddPCR, flow cytometry, cell-based assays, and other viral vector characterization techniques
- Support method qualification, validation, transfer, and technology transfer activities
- Drive laboratory operations, capacity planning, LIMS implementation, and continuous improvement initiatives
- Serve as SME during client audits and regulatory inspections
- Ensure compliance with cGMP, GLP, FDA, EMA, ICH, and other applicable regulatory requirements
Ideal Background:
- Bachelor's degree in a scientific discipline (Master's preferred)
- 7 years of QC leadership experience within biologics, cell therapy, gene therapy, or related sectors
- Strong expertise in bioanalytical methods, microbiological testing, and environmental monitoring
- Experience supporting viral vector manufacturing and testing programs
- Proven leadership, communication, and stakeholder management skills
Why Consider This Opportunity?
- Join one of the fastest-growing organizations in the Cell & Gene Therapy space
- Significant influence on company strategy and quality operations
- Direct exposure to clients and executive leadership
- Strong opportunities for career progression as the organization continues to scale
- Highly competitive compensation package
If you're interested in learning more, or know someone who may be a fit, feel free to reach out for a confidential discussion.