QC Analyst III

Neurona Therapeutics; South San Francisco (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Neurona Therapeutics in South San Francisco, CA seeks a QC Analyst III to support analytical testing for the clinical pipeline. The role reports to the Senior QC Manager and focuses on release, stability, and characterization assays, including flow cytometry, ddPCR, UPLC, and cell-based potency/viability tests.

The ideal candidate has 4–6 years in a cGMP QC lab, strong hands-on lab skills, and a track record of collaboration across QA, Assay Development, and Manufacturing to maintain regulatory

Qualifications

• Bachelor’s degree in life science; advanced degree preferred.
• 4–6 years of analytical laboratory experience in a cGMP biopharmaceutical QC environment.
• Experience with Flow Cytometry, ddPCR, UPLC, and cell-based assays.
• Working knowledge of cGMP regulations, ICH guidelines, and USP/EP standards.
• Experience authoring deviations, investigations, and SOPs.

Responsibilities

• Coordinate QC testing during active testing windows and support clinical manufacturing operations.
• Lead and mentor QC personnel on analytical methods, instrumentation, and best practices.
• Perform cGMP testing for in-process samples, drug substance, drug product release, and stability protocols.
• Verify analytical reports, data, and associated GxP documentation for accuracy and regulatory compliance.
• Participate in investigations of deviations, CAPA implementation, and lifecycle management with QA and Assay Development.

Skills

Flow Cytometry

ddPCR

UPLC

Cell-based assays

Education

Bachelor’s degree in life science

Advanced degree preferred

Job description

We are hiring! Our ideal candidates are self-motivated individuals who have clearly demonstrated a passion for scientific research. This is a fantastic opportunity to join a small team, work on transformative science, and build an exciting, science-driven company. Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

Position:QC Analyst III

Location: South San Francisco, CA

Job Id:375

# of Openings:1

Title: QC Analyst III

Work Type: On-site

Location: South San Francisco, CA Work Type: On-site

About Neurona Therapeutics

Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on developing neuronal cell-based therapies for intractable neurological diseases. We are seeking a highly motivated and detail-oriented candidate to join our Quality Control team. Our ideal candidate is organized, has strong hands-on laboratory experience, and can thrive in a fast-paced, dynamic, and collaborative environment.

Role Overview

The QC Analyst III will report directly to the Senior QC Manager and support analytical testing operations for Neurona’s clinical pipeline. This role coordinates daily testing execution, manages shift priorities, and serves as the primary technical point of escalation on the floor for analytical assays. Maintaining active bench engagement, the QC Analyst III will independently execute complex release, stability, and characterization assays—specifically focusing on multiparameter flow cytometry, digital droplet PCR (ddPCR), UPLC, and cell-based potency/viability assays. Additionally, this individual will mentor junior analysts, perform peer data review, author technical quality records, and partner closely with Assay Development and QA to ensure robust analytical performance and strict cGMP compliance.

Operational Coordination

• Serve as a technical contact between Analytical QC, Manufacturing, and Quality Assurance during active testing windows.
• Lead timely performance of QC assays in the laboratory to support clinical manufacturing operations.
• Support the QC Management in maintaining laboratory readiness through compliance with 5S practices, including reagent inventory, control materials, and analytical instrument (validation, calibration, PM).
• Train and mentor QC personnel on analytical methods, instrumentation, and laboratory best practices.

Analytical Testing & Data Analysis

• Perform cGMP testing for in-process samples, drug substance, drug product lot release, and stability protocols.
• Serve as a technical SME for Flow Cytometry, UPLC, ddPCR, and cell-based assays, providing troubleshooting and scientific support, or escalation to QC Management as needed.
• Verification of analytical testing reports, analytical data, test records, and associated GxP documentation to ensure accuracy, completeness, and compliance to regulatory standards.

Quality Systems, Investigations & Method Lifecycle

• Participate in investigations of analytical deviations, laboratory events, and OOS/OOT results, including root cause analysis and CAPA implementation in partnership with QC QA.
• Author and maintain SOPs, analytical methods, analyst qualification documents, protocols, and technical reports.
• Support analytical method transfers, qualifications, validations, and lifecycle management in collaboration with Assay Development and Process Sciences.

Qualifications & Experience

• Bachelor’s degree in a life science discipline; advanced degree preferred.
• 4-6 years of analytical laboratory experience in a cGMP biopharmaceutical, biotechnology, or cell/gene therapy QC environment.
• Strong preference for candidate with demonstrated proficiency in Flow Cytometry, ddPCR, UPLC, and cell-based assays.
• Working knowledge of cGMP regulations, ICH guidelines, and USP/EP standards.
• Experience authoring deviations, investigations, and SOPs.
• Strong communication, organization, and time-management skills.

This job description is not exhaustive and not intended to cover all activities of the position. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice.

Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

Neurona Therapeutics
490 Forbes Blvd, Suite 600
South San Francisco, CA 94080
[e-mail]