Lead QC Bioassay Specialist, Cell Therapy

DiscGenics, Inc.; Salt Lake City (UT); On-site; USD 90,000 - 130,000; Full time

Job summary

DiscGenics, Inc. seeks a Supervisor for Quality Control (Bioassay) to lead the QC lab, overseeing a team of 1-5 analysts and ensuring potency, identity and functional bioassays support product release and stability testing.

The role includes equipment qualification, method validation, data integrity, investigations and staff training to maintain GMP compliance and align with DiscGenics Values.

Qualifications

• 6+ years in a laboratory setting with GMP experience.
• Experience supervising a laboratory team and leading projects.
• Hands-on cell-based/bioassay testing experience.
• Proficiency with QC documentation and SOPs.

Responsibilities

• Lead day-to-day QC operations for cell-based potency and identity assays.
• Oversee equipment qualifications, calibration and maintenance.
• Validate and transfer test methods for QC lab usage.
• Manage SOPs, LIRs and OOS records with CAPA follow-through.
• Provide training and supervise 1–5 QC analysts.

Skills

GMP experience

Bioassay

Cell culture

Leadership

Quality control

Education

Bachelor's in Cell Biology/Bioengineering/Biochemistry/Chemistry

Master's with 4 years experience

PhD with 2 years experience

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

DiscGenics, Inc. seeks a Supervisor for Quality Control (Bioassay) to lead the QC lab, overseeing a team of 1-5 analysts and ensuring potency, identity and functional bioassays support product release and stability testing.

The role includes equipment qualification, method validation, data integrity, investigations and staff training to maintain GMP compliance and align with DiscGenics Values.