Lead Commercial QC Laboratory Manager

Serán BioScience; Bend (OR); On-site; USD 120,000 - 170,000; Full time

Job summary

Serán BioScience is hiring a Commercial Quality Control Laboratory Manager to lead the day-to-day operations of the Commercial QC Lab, ensuring timely testing and product release in a cGMP environment.

You will oversee investigations, deviations, CAPAs, changes, and test scheduling while partnering with Manufacturing, Supply Chain, and QA to maintain inspection readiness and continuous improvement.

Qualifications

• Bachelor’s degree in chemistry, physics, engineering, or related scientific discipline.
• 5+ years of GMP laboratory experience with supervisory responsibilities.
• Experience supporting FDA/client/regulatory inspections.

Responsibilities

• Recruit, interview, hire, onboard, train, and develop QC lab personnel.
• Provide daily leadership, coaching, and technical guidance to staff.
• Manage daily QC lab operations and testing priorities.
• Ensure timely release, in-process, and stability testing.
• Lead investigations of OOS/OOT, deviations, CAPAs, and changes.
• Maintain ALCOA++ data integrity and inspection readiness.
• Support audits, regulatory inspections, and client interactions.
• Oversee stability program execution and documentation.

Skills

cGMP compliance

FDA/ICH/USP knowledge

Analytical testing leadership

Laboratory investigations (OOS/OOT)

Project management

QA liaison & compliance

Education

Bachelors in chemistry/physics/engineering

Advanced degree preferred

Tools

LIMS

Empower

NuGenesis

Job description

Serán BioScience is hiring a Commercial Quality Control Laboratory Manager to lead the day-to-day operations of the Commercial QC Lab, ensuring timely testing and product release in a cGMP environment.

You will oversee investigations, deviations, CAPAs, changes, and test scheduling while partnering with Manufacturing, Supply Chain, and QA to maintain inspection readiness and continuous improvement.