Analytical Development & QC Leader (Gene Therapy)

Genezen; Indianapolis (IN); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Paid vacation days, amount based onten

401(k) plan with company match up to 6

Choice of several healthcare plans

FSA and HSA programs

Employer-paid basic term life/personal

Voluntary disability, universal life/p

Job summary

Genezen in Indianapolis, IN is seeking a Senior Manager/Associate Director, Analytical Development & Quality Control to lead analytical development and QC for viral vector programs (AAV, LVV, RVV). You will drive an integrated lifecycle, from method development to GMP execution and regulatory readiness.

You will partner across AD, QC, QA, RA, Manufacturing, and Process Development to align analytical activities with program needs and inspection readiness, building high-performing teams in a

Qualifications

• Minimum 4 years in a leadership role.
• Minimum 8-10 years progressive experience in analytical development, quality control, or related discipline within biopharma or CDMO environments.
• Extensive experience supporting viral vector products across clinical development phases and regulatory submissions.
• Demonstrated success leading analytical development, method validation, and QC Operations in a cGMP environment.

Responsibilities

• Lead analytical method development, qualification, validation, transfer, and lifecycle activities in alignment with ICH Q2/Q10/Q14 principles and program requirements.
• Oversee QC laboratory operations including in-process, release, and stability testing; provide decision authority for analytical readiness.
• Own governance of shared laboratory infrastructure, equipment lifecycle, prioritization, and resource allocation.
• Serve as SME during regulatory inspections and client audits for analytical and QC functions; support regulatory filings and analytical justifications.

Skills

qPCR/ddPCR

ELISA

Flow cytometry

Cell-based potency assays

Genome integrity assays

Empty/full capsid analysis

Education

BS in Molecular Biology, Biochemistry, Chemistry or related field

MS in Molecular Biology, Biochemistry, Chemistry or related field

Tools

LIMS

Job description

Genezen in Indianapolis, IN is seeking a Senior Manager/Associate Director, Analytical Development & Quality Control to lead analytical development and QC for viral vector programs (AAV, LVV, RVV). You will drive an integrated lifecycle, from method development to GMP execution and regulatory readiness.

You will partner across AD, QC, QA, RA, Manufacturing, and Process Development to align analytical activities with program needs and inspection readiness, building high-performing teams in a