Director of QC 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 scientific oversight for QC operations supporting clinical and commercial biopharmaceutical manufacturing in a fast-paced, regulated environment.

You will drive method lifecycle management, lead investigations (OOS/OOT), and develop a high-performing team focused on data integrity, regulatory compliance, and continuous improvement across GMP labs.

Qualifications

• 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

Responsibilities

• 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

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 Guidelines

USP

EP

EU Annexes

ICH Guidelines

Education

Bachelor's in Chemistry/ Biochemistry/ Biology

Job description

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

You will drive method lifecycle management, lead investigations (OOS/OOT), and develop a high-performing team focused on data integrity, regulatory compliance, and continuous improvement across GMP labs.