Director, Analytical Development & Quality Control

Responsibilities

• Develop and execute long-term strategy for Analytical Development (AD) and Quality Control (QC)
• Lead analytical method development, qualification, validation, and lifecycle management
• Oversee QC laboratory operations including in-process, release, and stability testing
• Direct investigations such as OOS, OOT, and deviations, ensuring effective CAPA implementation
• Govern shared laboratory infrastructure, equipment lifecycle, and resource allocation
• Serve as SME for aseptic processing, contamination control, and microbiological monitoring
• Ensure compliance with cGMP, GLP, FDA, EMA, and other regulatory requirements
• Oversee LIMS, analytical systems, and data integrity (ALCOA+, Part 11)
• Lead and develop high-performing hybrid teams through coaching and performance management

Requirements

• MS in Molecular Biology, Biochemistry, Chemistry or related field (PhD preferred)
• Minimum 5 years in a leadership role
• 12-15 years progressive experience in analytical development or QC within biopharma or CDMO
• Extensive experience supporting viral vector products (AAV, LVV, RVV)
• Proven success leading method validation and QC operations in a cGMP environment
• Proficiency in qPCR, ddPCR, ELISA, Flow cytometry, and cell-based potency assays
• Strong knowledge of cGMP, GLP, FDA, EMA, and ICH requirements
• Experience with environmental monitoring and contamination control

Benefits

• Paid vacation days based on tenure
• Paid sick time
• 10 observed holidays plus 2 floating holidays and 1 volunteer day
• 401(k) plan with company match up to 6%
• Share Appreciation Rights
• Comprehensive healthcare, dental, and vision plans
• FSA and HSA programs
• Employer-paid basic term life and personal accident insurance

About the Company

Genezen provides process development, GMP viral vector production, and cell transduction for gene and cell therapy clinical trials to help bring new cures to patients.