Associate Director, GMP Operations

BioAgilytix

North Carolina

On-site

USD 170,000 - 210,000

Full time

5 days ago

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Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Flexible Spending Account

Paid Time Off (4 weeks)

401k with Employer Match

Job summary

BioAgilytix in Raleigh-Durham seeks an Associate Director to lead GMP laboratory operations supporting lot release and stability testing for biologics, gene therapies, cell therapies, and related products. This role leads multiple teams through managers and supervisors, accountable for scientific quality, operational performance, capacity, and reliable delivery.

The ideal candidate will bring strong GMP laboratory experience with lot release and stability testing, plus experience supporting

Qualifications

Bachelor’s degree in scientific discipline, life sciences, operations, quality, or a related field.
Eight or more years in a regulated laboratory, pharmaceutical, biotech, CDMO, CRO, bioanalytical, quality, or scientific operations environment
Six or more years of people leadership
Technical and operational leadership of GMP sample analysis supporting lot-release, stability, characterization, or other specification-driven testing
Client support or internal scientific stakeholder management within a regulated environment
An equivalent combination of directly relevant education, training, and experience may be considered

Responsibilities

Lead managers, supervisors, and scientific teams responsible for GMP laboratory operations, with accountability for performance, quality, capacity, and delivery
Oversee GMP sample analysis supporting lot release, stability, characterization, and other specification-driven testing
Provide technical and operational oversight for validated and transferred analytical methods throughout the method lifecycle
Evaluate assay performance and lead the resolution of complex scientific and operational issues
Lead or oversee laboratory investigations involving deviations, out-of-specification and out-of-trend results, CAPAs, change controls, root-cause analysis, and effectiveness monitoring
Review and approve GMP laboratory documentation, which may include raw data, analytical data packages, test methods, protocols, reports, certificates of analysis, and investigation records
Establish and monitor laboratory, operational, and assay-performance metrics. Identify adverse trends and implement sustainable corrective or preventive actions
Monitor capacity, throughput, utilization, and backlog and take action to improve performance and delivery
Standardize workflows, management routines, metrics, and escalation processes across the assigned area
Resolve cross-functional issues affecting staffing, quality, timelines, and client commitments
Build effective relationships with clients and internal partners across Operations, Quality Assurance, scientific functions, and other business teams
Support client audits, regulatory inspections, and the preparation of technical responses
Develop managers and supervisors, strengthen leadership capability, and support succession planning across the organization
Contribute to budget planning, headcount planning, audit readiness, and process-improvement initiatives
Translate departmental goals into operating plans and communicate progress, risks, and mitigation actions to leadership
Perform other duties as assigned