Associate Director, GMP Lab Operations

BioAgilytix Labs, LLC; Durham, Northern (NC, KY); Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

FSA (Medical/Dependant Care)

Short/Long Disability Insurance

Paid Time Off

Parental Leave

Paid Holidays

401k Matching

Employee Referral Program

Job summary

BioAgilytix Labs, LLC is seeking an Associate Director to lead GMP laboratory operations at our Raleigh-Durham facility. You will oversee multiple teams through managers and supervisors, accountable for performance, quality, capacity, and reliable delivery.

The role requires strong GMP experience, especially with lot release and stability testing, plus experience supporting external clients or internal stakeholders. Some travel may be required.

Qualifications

• Bachelor’s degree in scientific discipline, life sciences, operations, quality, or related field.
• Eight (8) or more years in a regulated laboratory/biopharma setting.
• Six (6) or more years of people leadership.
• Technical and operational leadership of GMP sample analysis.
• Client support or internal stakeholder management in a regulated environment.

Responsibilities

• Lead managers, supervisors, and scientific teams responsible for GMP laboratory operations.
• Oversee GMP sample analysis supporting lot release, stability, characterization, and testing.
• Provide technical and operational oversight for validated and transferred analytical methods.
• Review GMP documentation including raw data, test methods, and reports.
• Develop leaders, maintain metrics, and drive continuous improvement across the operation.
• Support client audits and regulatory inspections.

Skills

GMP knowledge & controls

Data integrity

Analytical method lifecycle management

CAPA & change controls

Leadership & supervision

Decision making under changing priorit

Education

Bachelor's degree in life sciences/related field

Advanced degree preferred

Tools

HPLC/UHPLC

qPCR/ddPCR

Flow cytometry

ELISA and ligand-binding assays

Job description

BioAgilytix Labs, LLC is seeking an Associate Director to lead GMP laboratory operations at our Raleigh-Durham facility. You will oversee multiple teams through managers and supervisors, accountable for performance, quality, capacity, and reliable delivery.

The role requires strong GMP experience, especially with lot release and stability testing, plus experience supporting external clients or internal stakeholders. Some travel may be required.