Sr. Manager​/Associate Director, Analytical Development & Quality Control

Sr. Manager/Associate Director, Analytical Development & Quality Control

Indianapolis, IN

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work.

Every employee contributes to the success of the company and you can be part of that team.

The Senior Manager/Associate Director, Analytical Development & Quality Control provides strategic, scientific, and operational leadership for analytical development and QC functions supporting viral vector programs (AAV, LVV, RVV). This role is accountable for integrating Analytical Development and Quality Control into a unified, phase-appropriate analytical lifecycle that supports both scientific innovation and GMP execution. The position ensures delivery of compliant, scalable, and robust analytical capabilities from development through commercialization while maintaining inspection readiness and data integrity.

This role serves as the single point of accountability for analytical science and QC execution, ensuring that development, regulatory expectations, and GMP operations are fully integrated into a scalable, inspection-ready analytical framework.

Strategy & Analytical Governance

• Develop and execute the long-term strategy for Analytical Development (AD) and Quality Control (QC) aligned with business objectives and growth plans.
• Establish and govern the end-to-end analytical lifecycle, ensuring alignment between AD and QC in a shared laboratory environment.
• Define and maintain the analytical control strategy, including specification setting, method selection, and lifecycle management across development stages.
• Translate organizational goals into capability roadmaps (platforms, automation, digital systems, laboratory infrastructure).
• Drive harmonization, scalability, and future-readiness of analytical capabilities.

Analytical Development & Lifecycle Management

• Lead analytical method development, qualification, validation, transfer, and lifecycle management in alignment with ICH Q2/Q10/Q14 principles.
• Establish robust method transfer processes, including acceptance criteria, readiness assessments, and ongoing performance monitoring.
• Develop analytical platforms and reference standards supporting viral vector characterization.
• Define and govern sampling strategies to ensure representative and compliant testing.

Quality Control Operations & Stability

• Lead QC laboratory operations supporting in-process, release, and stability testing.
• Provide technical decision authority for analytical readiness, method suitability, and QC support of batch disposition.
• Oversee stability strategies, including protocol design, trending, and shelf-life justification.
• Direct investigations (OOS, OOT, deviations) and ensure effective CAPA implementation.
• Ensure QC operations maintain appropriate independence and objectivity in support of quality decisions.

Laboratory & Shared Infrastructure Governance

• Own governance of shared laboratory infrastructure, including equipment lifecycle management, scheduling prioritization, and resource allocation.
• Ensure appropriate segregation and controls for GMP and non-GMP activities within shared laboratory spaces.

Microbiology, EM & Contamination Control

• Serve as SME for aseptic processing, contamination control, and microbiological monitoring.
• Oversee environmental monitoring programs, trending, and control strategies.
• Ensure microbiological controls support product quality and regulatory compliance.

Regulatory Compliance & Inspection Readiness

• Ensure compliance with cGMP, GLP, FDA, EMA, and applicable regulatory requirements.
• Serve as…