Manager, Quality Control Bioassay

About the Role

We’re looking for a Manager, Quality Control - Bioassay on the Quality Control team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Quality Control, you’ll participate in the transfer, qualification, and optimization of methods in a Quality Control environment throughout the lifecycle of the method. This individual shall also be able to author and implement Quality Control area procedures for an AAV-based gene therapy laboratory.

Responsibilities

In this role, you’ll have the opportunity to 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. You’ll also:

• Actively participate and manage 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
• Participate in developing timelines, protocols, and reports for assay transfers, qualifications, and validations
• Interact with CDMOs as a subject matter expert to support method transfer and testing activities
• Author and review QC analytical SOPs, protocols, and reports as needed
• 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 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
• Learn and become proficient in all laboratory instrument software to conduct testing
• Establish laboratory procedures and participate in hiring QC staff

Requirements

• Bachelor’s degree along with 7 years or MS with a minimum of 5 years of relevant industry experience
• Experience in the 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
• Experience in optimizing methods with particular emphasis on cell-based potency assays, molecular biology assays, and protein chemistry assays
• Experience with related instrumentation and software used for cell-based potency assays such as JESS, droplet digital PCR systems, cell counters, PLA, etc.
• Significant experience in an FDA-regulated environment
• Entrepreneurial spirit, with a strong willingness to take on new challenges required to bring novel medicines to the clinic
• Excellent organizational and communication skills

Nice to Have

• Experience with JMP statistical software (a plus)

Schedule

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.

Minimal travel expected.

Pay

$124,000.00 - $161,000.00 Annual

Benefits

Highlights of our U.S. offerings include:

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill-building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.