Director, Quality Control Analytical Sciences & Technology

BioTalent; Tustin (CA); On-site; USD 163,000 - 204,000; Full time

Job summary

BioTalent is seeking a Director, Quality Control Analytical Sciences & Technology to lead analytical strategy and provide scientific oversight for QC operations supporting clinical and commercial biopharmaceutical manufacturing.

You will drive lifecycle management of GMP analytical methods, oversee investigations, and champion continuous improvement while leading a high-performing team and partnering with QA, Regulatory, and clients.

Qualifications

• B.S. in Chemistry, Biochemistry, Biology or related field; M.S. or higher preferred.
• Minimum 10 years of industry experience in a QC or analytical laboratory.
• Experience with GMP environments, analytical testing, reports, procedures and regulatory audits.

Responsibilities

• Lead the lifecycle management and governance of GMP analytical methods to ensure they remain fit-for-purpose and compliant throughout their lifecycle.
• Serve as the scientific leader for complex OOS, OOT, deviation, atypical result, and recurring invalid assay investigations.
• Drive root cause investigations, CAPAs, risk mitigation, and analytical continuous improvement initiatives.
• Oversee analytical performance monitoring programs, statistical trending, dashboards, and management reviews.
• Establish and maintain analytical control strategies, method governance processes, and performance metrics.
• Lead and develop the Analytical Sciences & Technology team with resource planning and succession planning.
• Partner with QC Operations, Analytical Development, MS&T, QA, Regulatory Affairs, and clients on strategy and issue resolution.
• Serve as the analytical SME during audits, inspections, regulatory submissions, client interactions, and strategic initiatives.

Skills

Quality Control

Analytical Sciences & Technology

Analytical Testing

Laboratory Instrumentation

GMP Compliance

OOS/OOT Investigations

Deviation Management

Method Lifecycle Management

Statistical Trending

Regulatory Compliance

FDA GuidelinesUSP

EP

EU Annexes

ICH Guidelines

Education

Bachelor's in Chemistry/Biochemistry/Biology

MS or higher preferred

Tools

Analytical Instruments

Laboratory Automation

Job description

Director, Quality Control Analytical Sciences & Technology

Lead Analytical Excellence in Biopharmaceutical Quality Control

Great opportunity for experienced Quality Control leaders with strong analytical sciences expertise in GMP biologics manufacturing

Are you passionate about analytical method lifecycle management, scientific leadership, and quality excellence? We're looking for a Director, Quality Control Analytical Sciences & Technology to lead analytical strategy and provide scientific oversight for Quality Control operations supporting clinical and commercial biopharmaceutical manufacturing.

If you thrive in a data-driven, highly regulated environment and enjoy solving complex analytical challenges while leading high-performing teams, this could be your next opportunity.

What You’ll Do

• Lead the lifecycle management and governance of GMP analytical methods to ensure they remain fit-for-purpose and compliant throughout their operational lifecycle
• Serve as the scientific leader for complex OOS, OOT, deviation, atypical result, and recurring invalid assay investigations
• Drive root cause investigations, corrective actions, risk mitigation strategies, and analytical continuous improvement initiatives
• Oversee analytical performance monitoring programs, statistical trending, dashboards, and management reviews
• Establish and maintain analytical control strategies, method governance processes, and performance metrics
• Lead and develop the Analytical Sciences & Technology team, ensuring effective resource allocation and succession planning
• Partner with QC Operations, Analytical Development, MS&T, QA, Regulatory Affairs, and clients on analytical strategy and issue resolution
• Serve as the analytical SME during audits, inspections, regulatory submissions, client interactions, and strategic business initiatives

What We’re Looking For

B.S. in Chemistry, Biochemistry, Biology, or a related scientific field required; M.S. or higher preferred

Minimum 10 years of industry experience in a QC or analytical laboratory

Experience with analytical testing and equipment, writing reports, procedures and specifications, GMP environments, and regulatory audits

• Quality Control
• Analytical Sciences & Technology
• Analytical Testing
• Laboratory Instrumentation
• GMP Compliance
• OOS/OOT Investigations
• Deviation Management
• Method Lifecycle Management
• Statistical Trending
• Regulatory Compliance
• FDA GuidelinesUSP
• EP
• EU Annexes
• ICH Guidelines

Base Salary: $163,000 - $204,000 annually, depending on experience and qualifications.

Additional compensation and benefits package available

Please Note

On-site in Tustin, CA

Full-time leadership position supporting biopharmaceutical Quality Control operations

Schedule is typically Monday through Friday, with overtime and weekend support as business needs require

Occasional overnight travel may be required for conferences, seminars, or client meetings

If this sounds like you, or someone in your network, I'd love to connect!