Associate Director of Lab Management and Stability

$123,528 - $185,292/Yr

AstraZeneca - Gaithersburg, MD

Full-time - Mid Level

Gaithersburg, MD

Chemical Manufacturing

About the position

The Associate Director of Lab Management and Stability is responsible for overseeing lab investigations, CAPAs, and continuous improvement initiatives within Quality Control. This role includes managing equipment maintenance, sample management, and ensuring data integrity, while also designing and implementing stability programs for commercial cell and gene therapy operations. The position requires collaboration with cross-functional teams to ensure compliance with GMP and regulatory standards, as well as leading and mentoring a team of QC professionals.

Responsibilities

• Provide development, leadership, and structure regarding investigations, CAPAs, and CI for Quality Control.
• Act as an interface between manufacturing, quality, validation, and relevant functions for Stability, Investigations, and Equipment Maintenance.
• Promote continuous improvements in working practices and procedures by liaising with laboratory staff and other functions.
• Lead the Stability and Lab Management team, providing support to broader QC operations.
• Maintain awareness of current regulatory and industry standards applicable to QC operations.
• Ensure timely, effective, and compliant output of the laboratories to meet customer and regulatory requirements.

Requirements

• Bachelor's Degree in Microbiology, Biological Sciences, or related discipline.
• 8+ years of experience in biopharma, medical device, or pharmaceutical manufacturing.
• 6+ years of experience with an Advanced Degree (MS or PhD).
• 2+ years of managerial/supervisory experience.
• Extensive experience in analytical testing within the pharmaceutical or biotechnology industry, with a preference for Stability experience.
• Experience with Laboratory Investigations and CAPAs.
• Ability to work in a matrix environment.
• Excellent communication skills and ability to develop rapport with other functional leaders.
• Ability to make effective decisions under pressure.

Nice-to-haves

• Cell Therapy Experience

Benefits

• 401(k) plan
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage
• Short-term incentive bonus opportunity
• Eligibility to participate in equity-based long-term incentive program
• Retirement contribution for hourly roles
• Commission payment eligibility for sales roles