QA & Regulatory Lead, iPSC Cell Therapy

Science; Alameda (CA); On-site; USD 135,000 - 195,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Equity

Flexible vacation and holidays

Paid parental, jury duty, bereavement,

401(k)

Job summary

Science is seeking a highly experienced QA lead for the Biohybrid Cells program in California. You will own end-to-end QC for the cell line, from incoming materials to lot release, and serve as the primary QA presence on the Cell team.

The role requires deep knowledge of 21 CFR Part 1271 (cGTP) and GMP for cellular products, with hands-on IND support and QMS management in a fast-moving, clinical-stage environment.

Qualifications

• Bachelor's degree or higher in life sciences, cell biology, bioengineering, or a related field.
• Minimum 5 years of quality experience in a cellular therapy, biologics, or combination product environment.
• Hands-on experience with IND preparation and filing, including authoring or reviewing CMC quality sections for a cell therapy or biologic IND.
• Deep working knowledge of 21 CFR Part 1271 (cGTP) and applicable GMP requirements for cellular products; familiarity with FDA guidance for cell and gene therapy.
• Demonstrated experience performing cell line QC: batch record review, lot release, out of spec investigation, and CoA issuance.
• Direct experience with environmental monitoring programs in a controlled biological processing environment.
• Ability to independently manage a phase-appropriate QMS with limited administrative support in a fast-moving environment.

Responsibilities

• Own QC testing and lot release for cell banks (identity, viability, sterility, mycoplasma, endotoxin).
• Author and execute batch records; ensure traceability from incoming material through cryopreservation.
• Establish and maintain CoA templates, and OOS investigation procedures.
• Manage incoming QC for biological materials, reagents, and consumables; document inspections.
• Define and implement in-process controls.
• Investigate deviations, non-conformances, and OOS results; lead root cause analysis and CAPA.

Skills

QC testing

Batch records

CAPA

QMS management

Environmental monitoring

IND preparation

GMP compliance

Deviations investigation

Education

Bachelor's degree or higher in life sciences

Tools

Asana

Job description

Science is seeking a highly experienced QA lead for the Biohybrid Cells program in California. You will own end-to-end QC for the cell line, from incoming materials to lot release, and serve as the primary QA presence on the Cell team.

The role requires deep knowledge of 21 CFR Part 1271 (cGTP) and GMP for cellular products, with hands-on IND support and QMS management in a fast-moving, clinical-stage environment.