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

genezenlabs; Indianapolis (IN); On-site; USD 150,000 - 210,000; Full time

Job summary

Genezen seeks a Senior Manager/Associate Director of Analytical Development & Quality Control to provide strategic leadership from development through commercialization. This role unifies analytical development and QC to deliver compliant, scalable capabilities while ensuring inspection readiness and data integrity.

The candidate will drive lifecycle governance, method transfer, and platform development within a GMP environment, partnering with regulatory, manufacturing, and client teams.

Responsibilities

• Lead analytical method development, qualification, and validation.
• Oversee QC testing, release, and stability programs.
• Ensure cGMP/GLP compliance and inspection readiness.
• Drive data integrity and digital systems across laboratory functions.

Skills

Analytical development leadership

Quality Control

GMP & regulatory compliance

Cross-functional collaboration

Regulatory inspections

Tools

LIMS

Job description

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.

WORKING AT GENEZEN

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.

JOB SUMMARY

The Senior Manager/Associate Direct, 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.

ESSENTIAL JOB FUNCTIONS

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 primary SME during regulatory inspections and client audits for analytical and QC functions.
• Support regulatory filings, responses, and analytical justification strategies.
• Maintain continuous inspection readiness across laboratory operations.

Data Integrity, Systems & Continuous Improvement

• Oversee LIMS, analytical systems, and data integrity (ALCOA+, Part 11) across all laboratory functions.
• Implement digital solutions, automation, and process improvements to enhance efficiency and compliance.
• Establish and monitor performance metrics (e.g., turnaround time, right-first-time, deviation trends).

Client & Cross-Functional Leadership

• Act as executive scientific partner for clients and internal stakeholders. Drive alignment across Process Development, Manufacturing, QA, and RA on analytical st