Manager, Quality Control Bioassay

About the role

We're seeking a Manager, Quality Control - Bioassay to join our Quality Control team. Reporting to the Associate Director, Quality Control, you'll oversee the transfer, qualification, and optimization of methods in a GMP environment, focusing on cell-based biological potency assays, protein chemistry assays, and molecular biology assays.

Responsibilities

• Provide oversight of cell-based biological potency assays, protein chemistry assays, and molecular biology assays for process monitoring, stability, and release in a GMP environment such as SDS-PAGE, western blot, ddPCR or qPCR, and culture of primary mammalian cells.
• Actively participate and manage in the timely execution of all routine QC testing, data review, and preparation of summary reports.
• Supervise and manage day-to-day activities of direct reports.
• Develop timelines, protocols, and reports for assay transfers, qualifications / validations.
• Interact with Contract Development and Manufacturing Organizations (CDMOs) as a subject matter expert to support method transfer and testing activities.
• Author and review QC analytical SOPs, protocols, and reports as needed.
• May act as an analytical lab representative on a CMC team.
• Perform quality management activities such as deviation, CAPA, change control, investigation of OOS, OOT and anomalous results within the company QMS according to established procedures.
• Maintain QC laboratory, track critical reagents and equipment logbooks, and ensure all the equipment is calibrated.
• Utilize the LIMS system to submit samples, enter data, and track samples.
• Utilize statistical analysis software to generate assay control charts and recommend assay acceptance criteria.
• Establish laboratory and participate in hiring QC staff.

Requirements

• You have a bachelor’s degree along with 7 years or MS with a minimum of 5 years of relevant industry experience.
• You have experience in pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with experience in a GMP QC release testing role.
• You have significant experience in an FDA-regulated environment.
• You have an entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic.
• You have excellent organizational and communication skills.

Qualifications

• Nice to have (but not required): Experience with JMP statistical software.

Where You’ll Work

This role is based out of our San Diego office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

Pay

The pay range for this role is $124,000.00 - $161,000.00 annually.