GMP Operations Director - Biologics & Lab Leadership

BioAgilytix; Durham (NC); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k with Employer Match

Paid Time Off

Parental Leave

Paid Holidays

Employee Referral Program

Job summary

BioAgilytix seeks an Associate Director to lead GMP laboratory operations at our Raleigh-Durham facility, supporting lot release and stability testing for biologics, gene therapies, and cell therapies. The role oversees multiple teams through managers and supervisors, ensuring quality, capacity, and reliable delivery to clients.

The ideal candidate has strong GMP laboratory experience, leadership, and a track record of working with external clients or internal stakeholders.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Eight (8) or more years in a regulated lab or biotech environment.
• Six (6) or more years of people leadership.
• Experience leading GMP sample analysis for lot release, stability, or testing.
• Client support or stakeholder management in regulated settings.

Responsibilities

• Lead managers and teams responsible for GMP laboratory operations and delivery.
• Oversee GMP sample analysis for lot release and stability testing.
• Provide oversight for validated and transferred analytical methods.
• Review GMP documentation including data packages and reports.
• Establish laboratory metrics and monitor performance and trends.
• Support client audits and regulatory inspections.
• Develop leaders and succession planning across the org.
• Participate in budget and headcount planning.

Skills

GMP operations

Data integrity

Analytical methods lifecycle

Leadership

Cross-functional collaboration

Quality systems

Client management

Education

Bachelor’s degree in life sciences or related field

Tools

HPLC/UHPLC

qPCR/ddPCR

Flow cytometry

ELISA

CAPA systems

Job description

BioAgilytix seeks an Associate Director to lead GMP laboratory operations at our Raleigh-Durham facility, supporting lot release and stability testing for biologics, gene therapies, and cell therapies. The role oversees multiple teams through managers and supervisors, ensuring quality, capacity, and reliable delivery to clients.

The ideal candidate has strong GMP laboratory experience, leadership, and a track record of working with external clients or internal stakeholders.