Quality and Regulatory Affairs Engineer, 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 a clinical stage, vertically integrated technology company focused on solving some of neuroscience's hardest questions and most serious unmet medical needs. We work to restore quality of life to those with debilitating conditions for which there are no treatment options, creating devices aimed at restoring vision, cognition, and mobility to patients who have lost it. To support progress across our industry, we provide state-of-the-art components and vertically integrated infrastructure for others to build on via Science Foundry.

This role is embedded directly in Science's Biohybrid Cells program, which is actively transitioning from R&D-stage workflows to cGTP-compliant, GMP-like operations in support of IND filing. You will own quality control of the cell line end-to-end, from incoming material and process controls through lot release, and serve as the primary QA presence on the Cell team.

This is a hands-on role requiring deep familiarity with both the regulatory framework for cellular products (21 CFR Part 1271, IND-enabling requirements) and the practical reality of running QC in a live cell processing environment. You will work closely with the Biohybrid scientific team, external CMO partners, and the broader QARA function to build and execute quality systems that are phase-appropriate, auditable, and positioned for clinical-stage scale-up.

Role Responsibilities:

Cell Line Quality Control & Lot Release

• Own QC testing documentation and lot release for cell banks including identity, viability, sterility, mycoplasma, endotoxin, and genomic integrity testing
• Author and execute batch records; ensure complete traceability from incoming material through cryopreservation
• Establish and maintain Certificate of Analysis (CoA) templates, and out-of-specification (OOS) investigation procedures
• Manage incoming QC for biological raw materials, reagents, and consumables; execute and document incoming inspection per approved procedures
• Define and implement in-process controls
• Investigate deviations, non-conformances, and OOS results; lead root cause analysis and CAPA implementation

cGTP/GMP Compliance & IND Support

• Serve as the QA subject matter expert for 21 CFR Part 1271 (cGTP) and applicable GMP requirements for combination product cellular components
• Support IND-enabling activities: author or review the quality sections of the IND submission, including CMC narrative, process description, and QC testing plan for the cell line
• Build and maintain the Cell QMS: - SOPs, controlled forms, training records, deviation management, and CAPA
• Lead the QAU audit and inspection schedule for Cell operations; conduct internal audits and prepare the program for regulatory inspections
• Manage the supplier qualification program for iPSC-specific vendors, including biological reagent suppliers, specialized equipment vendors, and contract service providers
• Oversee document and record control specific to the iPSC program; ensure GDP compliance across all batch records, logbooks, and controlled documents

Controlled Environment & Equipment

• Own the environmental monitoring program for controlled PD suite operations: sampling schedule, alert/action limits, trend analysis, and response to excursions
• Maintain QA oversight of equipment qualification and calibration records for the iPSC processing suite; coordinate IQ/OQ/PQ for new or modified equipment
• Review and approve facility-related SOPs including gowning, sanitation, biosafety cabinet certification, cleanroom entry, and contamination response procedures
• Partner with the Biohybrid team to assess and document facility readiness as controlled operations scale toward clinical-grade cell processing

CMO & External Partner Quality

• Serve as the QA interface with external partners (e.g. CDMO) performing master cell bank establishment or downstream manufacturing activities; draft and maintain quality agreements
• Review and approve CMO batch records, test reports, and deviations; conduct or participate in supplier audits and qualification activities
• Manage material transfer agreements (MTAs) with quality terms; ensure incoming materials from CMO partners meet defined acceptance criteria before use in controlled operations

Training & Cross-Functional Support

• Develop and deliver cGTP and GMP training programs for iPSC operations staff; ensure documented competency prior to initiation of controlled activities
• Contribute to broader QARA team functions including QMS maintenance, CAPA, management review, and the internal audit program
• Provide QA input on the iPSC program's transition plan from engineering runs to controlled operations and ultimately to clinical-grade manufacturing

Key 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

Preferred Qualifications:

• Direct experience with iPSC culture, banking, or gene editing workflows (e.g., CRISPR/Cas9) from a QA or QC perspective
• Experience supporting FDA pre-IND meetings or responding to agency questions on cellular product quality
• Familiarity with combination product regulatory pathways (21 CFR Part 3; FDA OTAT/OCP interactions)
• Experience qualifying or auditing external CMOs or cell therapy contract manufacturers
• Knowledge of ISO 13485 and medical device QMS requirements in the context of combination products
• Proficiency with electronic QMS and batch record systems; proficiency with project management tools (e.g., Asana)

Science is required under California law to include a reasonable estimate of the compensation range for this role. We determine your level based on your interview performance and make an offer based on the indicated salary band. The base salary range for this full-time position is $135,000-$195,000 annually + equity + benefits. Within the range, individual pay is determined by several factors, including job-related skills, experience, and relevant education or training. Please keep in mind that the equity portion of the offer is not included in these numbers.

• At Science, our benefits are in place to support the whole you:
• Competitive salary and equity
• Medical, dental, vision and life insurance
• Flexible vacation and company-paid holidays
• Healthy meals and snacks provided for non-remote employees
• Paid parental, jury duty, bereavement, family care and medical leave
• Dependent Care Flexible Spending Account, subsidized by Science
• Flexible Spending Account
• 401(k)

Science Corporation is an equal opportunity employer. We strive to create a supportive and inclusive workplace where contributions are valued and celebrated, and our employees thrive by being themselves and are inspired to do their best work.

We seek applicants of all backgrounds and identities, across race, color, ethnicity, national origin or ancestry, citizenship, religion, sex, sexual orientation, gender identity or expression, veteran status, marital status, pregnancy or parental status, or disability. Applicants will not be discriminated against based on these or other protected categories or social identities. Science will also consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state and local laws.