Want to know if this job is worth applying to?
Bend, Oregon, United States
Onsite
Not Available
Serán is expanding its Bend, Oregon campus with a new GMP manufacturing facility and is seeking an industry-experienced Commercial Quality Control Laboratory Manager to play a critical role in the facility start-up of the new QC laboratory including equipment and facility qualifications and FDA data integrity compliance. As a critical member of the Commercial Committee, the QC Commercial Laboratory Manager will be part of a cross-functional team who will plan and execute qualification projects, method transfers, validations, cleaning program, and computer system validations to support non-sterile pharmaceutical products.
Once the facility is underway, the Commercial Quality Control Manager will be responsible for leading the daily operations of the Commercial QC Laboratory in support of commercial manufacturing, raw material and product release, stability testing, and ongoing GMP compliance. This position ensures analytical testing is performed accurately, efficiently, and in compliance with current Good Manufacturing Practices (cGMP), ICH guidelines, FDA regulations, and company procedures.
The Commercial QC Laboratory Manager provides leadership to QC laboratory personnel, oversees laboratory scheduling and resource allocation, manages investigations, laboratory deviations, OOS/OOT events, change controls, and CAPAs, and partners closely with Manufacturing, Supply Chain, Analytical Development, and Quality Assurance to ensure timely release of commercial products.
This role is responsible for maintaining inspection readiness, driving operational excellence, developing laboratory personnel, and fostering a culture of quality, accountability, continuous improvement, and customer focus.
Bachelor’s degree in chemistry, physics, engineering, or related scientific discipline
Preference will be given to advanced degree holders or those with equivalent experience
5-10 years of relevant experience in CDMO laboratory
Requires 5 years of GMP experience
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 15 pounds at times.
Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701