Commercial QC Lab Manager: Lead Release & Compliance

Serán Bioscience, LLC; Bend (OR); On-site; USD 120,000 - 180,000; Full time

Job summary

Serán Bioscience, LLC seeks a Commercial Quality Control Laboratory Manager to lead the daily operations of the QC lab supporting commercial manufacturing, product release, and stability testing. Ensure testing is accurate, compliant with cGMP, ICH, FDA, and company procedures.

This role provides leadership to QC personnel, oversees scheduling, investigations, deviations, CAPAs, and change controls, and partners with Manufacturing, QA, and Supply Chain to timely release products.

Qualifications

• Bachelor’s degree in chemistry, physics, engineering, or related scientific discipline.
• Advanced degree or equivalent experience preferred.
• 5-10 years of relevant experience in laboratory.
• Requires 5 years of GMP experience.
• Previous management/supervisor experience in commercial Quality Control preferred.
• Experience supporting FDA, client, and regulatory inspections preferred.

Responsibilities

• Provide daily leadership, coaching, and technical guidance to QC staff.
• Manage daily operations of the Commercial Quality Control laboratory.
• Ensure timely release and testing for release, in-process, raw materials, cleaning verification, and stability testing.
• Coordinate scheduling and prioritize testing to support manufacturing and commitments.
• Monitor workload and turnaround times to ensure on-time product disposition.
• Lead investigations (OOS/OOT, deviations, CAPAs) and ensure timely closure.
• Support internal and client audits and regulatory inspections with compliant documentation.

Skills

cGMP & FDA compliance

Leadership & coaching

Analytical testing for release

OOS/OOT investigations

Chromatographic instrumentation

Data integrity (ALCOA++)

Communication skills

Project management

Education

Bachelor's degree in chemistry/physics/engineering

Advanced degree preferred

Tools

LIMS

Empower

NuGenesis

Job description

Serán Bioscience, LLC seeks a Commercial Quality Control Laboratory Manager to lead the daily operations of the QC lab supporting commercial manufacturing, product release, and stability testing. Ensure testing is accurate, compliant with cGMP, ICH, FDA, and company procedures.

This role provides leadership to QC personnel, oversees scheduling, investigations, deviations, CAPAs, and change controls, and partners with Manufacturing, QA, and Supply Chain to timely release products.