GMP Operations Leader for Biologics

Socket.dev; Durham (NC); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical Insurance

401k with Employer Match

Paid Time Off

Job summary

BioAgilytix in the Raleigh-Durham area seeks an Associate Director to lead GMP laboratory operations, oversee lot release and stability testing for biologics and related products, and guide multiple teams through managers and supervisors. The role emphasizes quality, capacity, and reliable delivery.

The ideal candidate will have strong GMP lab experience, hands-on leadership, and a track record supporting external clients or internal stakeholders in a regulated environment.

Qualifications

• Bachelor’s degree in scientific discipline required.
• Eight+ years in a regulated laboratory/pharma/biotech environment.
• Six+ years of people leadership experience.
• Technical leadership of GMP sample analysis for lot‑release, stability or related testing.
• Client support or internal scientific stakeholder management in regulated environments.

Responsibilities

• Lead managers, supervisors and teams responsible for GMP laboratory operations and delivery.
• Oversee GMP sample analysis supporting lot release, stability and related testing.
• Provide oversight for validated and transferred analytical methods across lifecycles.
• Lead investigations and CAPAs, root-cause analysis and corrective actions.
• Build relationships with clients and internal partners to support audits and inspections.

Skills

GMP expertise

Leadership

Analytical platforms

Regulatory audits

Problem solving

Communication

Cross-functional collaboration

Education

Bachelor’s degree in life sciences

Tools

HPLC/UPLC

qPCR

Flow cytometry

ELISA

Job description

BioAgilytix in the Raleigh-Durham area seeks an Associate Director to lead GMP laboratory operations, oversee lot release and stability testing for biologics and related products, and guide multiple teams through managers and supervisors. The role emphasizes quality, capacity, and reliable delivery.

The ideal candidate will have strong GMP lab experience, hands-on leadership, and a track record supporting external clients or internal stakeholders in a regulated environment.