Manager, Quality Control - Bioassay (Gene Therapy)

TL;DR

Manager, Quality Control - Bioassay (Gene Therapy): Overseeing cell-based biological potency, protein chemistry, and molecular biology assays in a GMP environment with an accent on method transfer, qualification, and validation. Focus on managing day-to-day QC operations, ensuring regulatory compliance, and supporting AAV-based gene therapy laboratory procedures.

Location: Must be based in San Diego, CA (Onsite)

Salary: $124,000–$161,000

Company

A global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Manage routine QC testing, data review, and summary report preparation.
• Supervise and lead day-to-day activities of direct reports.
• Develop timelines, protocols, and reports for assay transfers, qualifications, and validations.
• Interact with CDMOs as a subject matter expert for method transfer and testing.
• Perform quality management activities including deviations, CAPA, change control, and OOS/OOT investigations.
• Maintain QC laboratory equipment, logbooks, and ensure calibration compliance.

Requirements

• Bachelor’s degree with 7+ years or MS with 5+ years of relevant industry experience.
• Must be based in San Diego and available for full-time, in-person work.
• Experience in a GMP QC release testing role within the pharmaceutical industry.
• Strong background in optimizing cell-based potency, molecular biology, and protein chemistry assays.
• Significant experience working in an FDA-regulated environment.
• Proficiency with laboratory instrumentation and software (e.g., JESS, ddPCR, qPCR).

Nice to have

• Experience with JMP statistical software.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• 401(k) plan with company match and annual equity awards.
• Generous paid time off and flexible work schedules.
• Access to LinkedIn Learning, leadership programs, and mentorship opportunities.
• Supportive environment with employee resource groups and service programs.