Senior Manager, Analytical Development & QC Strategy

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

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.