---
title: 'Senior Analyst, Quality Control Analytical at GeneFab'
canonical: 'https://feeny.ai/job/senior-analyst-quality-control-analytical-genefab-alameda-ztpns2g1kxer'
type: 'job'
last_seen: '2026-09-11'
---

# Senior Analyst, Quality Control Analytical at GeneFab

- **Company:** GeneFab
- **Location:** Alameda, CA
- **Compensation:** $45–$55/hr
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-08-10
- **Last confirmed live:** 2026-09-11
- **Apply:** https://jobs.lever.co/genefab/e2355751-f430-4d0f-852f-94eab37c926b

## Job description

Genefab is seeking an experienced analyst to join it’s Quality Control Analytical group. In this role, you will support the GMP QC testing at GeneFab, with a focus on testing, method transfer, qualification, troubleshooting and investigations.

## Responsibilities

- Provide technical expertise (SME).
- Provide technical support to Analytical Development and QC Analytical Operations as needed.
- Develop, implement, and update all Quality Control SOPs, testing records and other documentation needed for cGMP compliance.
- Perform QC testing on in-process and final product samples to support release and stability testing.
- Lead and perform technical root-cause investigations for aberrant results and deviations relating to analytical methods.
- Lead and train junior employees to ensure testing procedures and practices comply with all applicable regulations and procedures.
- Plan, lead, and execute analytical method transfers, qualifications, and validations.
- Draft, Review, and Approve Method Transfer Protocols and Reports
- Generate and review procedures, protocols and reports.
- Proactively identify areas for continuous improvement in processes and procedures and lead these initiatives.
- Collaborate closely with Interdepartmental MSAT, ASAT, and Manufacturing groups to support, execute, and/or provide oversight in the execution of method optimization, characterization, troubleshooting, transfer, and qualification
- Perform additional duties as assigned

## Requirements

- B.S. degree in biology or related field with experience in cell therapy, immunology, cancer biology, or a closely related field.
- Minimum of 5+ years of GMP/QC Laboratory experience.
- Demonstrated ability to collaborate and work in cross-functional teams.
- Strong organizational skills and attention to detail
- Strong time management skills with a proven ability to meet deadlines
- Strong analytical and problem-solving skills
- Experience with relevant technologies such as: multicolor flow cytometry, cell culture (e.g., aseptic techniques, cell line expansion), multiplexed immunoassay, qPCR, and dPCR methods, Luminex, and ELISA.
- Experience in GMP.
- Experience with contract laboratories and or CDMO is a plus
- Knowledge related to laboratory information management systems (LIMS) and electronic lab notebook record keeping (ELN) is a plus
- Proficient in MS Word, Excel, Project, and PowerPoint
- Experience with cell therapy or gene therapy is a plus
- Availability to work extended hours such as evenings or weekends to meet deadlines when necessary
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the initial job description
- Able to lift up to 40 pounds

## About GeneFab

GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.

## About GeneFab

## Company Overview
- **One-liner**: GeneFab is a contract development and manufacturing organization (CDMO) that provides integrated synthetic biology, viral vector production, and cell therapy manufacturing services to innovators in the cell and gene therapy space.
- **Entity Type**: Private (funding stage not publicly available)
- **Headquarters**: Alameda, California, USA (cGMP manufacturing); additionally a SynBio Center of Excellence in South San Francisco, California, USA
- **Founded**: 2023
- **Founders**: Not publicly disclosed; key leadership includes Philip Lee (CEO) and Drew Johnston (President & COO)

## Core Business
- **Primary industry/industries**: Cell and gene therapy CDMO, synthetic biology, viral vector manufacturing, cell therapy contract manufacturing
- **Target customers**: Biotech and pharmaceutical companies developing cell and gene therapies (ex-vivo and in-vivo modalities) – primarily B2B serving innovators from research through commercial supply
- **Mission or purpose statement**: "To make innovative genetic medicines available for all."

## Products & Services
- **Ex Vivo Cell Therapy**: End-to-end autologous and allogeneic workflows covering CAR-T, TCR-T, CAR-NK, Treg, iPSC among others, with multiple expansion platforms tuned to the modality.
- **In Vivo Cell Therapy**: Optimization of genetic elements (e.g., cell-specific promoters) and manufacturing of the lentiviral vector that delivers the therapy directly to patients without an ex-vivo step.
- **Viral Vectors**: Production of lentivirus (LVV) and gamma-retrovirus (GRV) from adherent (2-20 L) to suspension GMP (50-200 L) scale, using stable producer lines.
- **Synthetic Biology**: Proprietary building blocks including cell-specific promoters, kill switches, custom producer cell lines, and ML-driven sequence design.
- **cGMP Manufacturing**: 42,000 sq ft purpose-built cGMP facility in Alameda with seven ISO 7 / Grade B suites, expandable to 92,000 sq ft, meeting FDA & EU GMP standards.
- **QC & Release**: In-house qualified methods running on a regular cadence for phase-appropriate quality release in days.
- **Process Development & Analytics**: Method development, qualification, and transfer; includes genetic circuit design, payload optimization, and analytical assay support.
- **Commercial Readiness & Supply**: Process performance qualification, BLA-readiness, and capacity to scale from clinical lots to commercial demand without changing partners.

## Market Standing
- **Valuation/Market Cap**: Not publicly disclosed
- **Key Metric**: 42,000 sq ft cGMP facility (opened 2023, expandable to 92,000 sq ft) with seven suites; implementing fully electronic quality and document control systems across 2026–2027 for BLA-readiness
- **Notable Investors/Partners**: Not publicly available
- **Growth Signals**: Active hiring via Lever portal (roles include bioprocess specialist, senior manufacturing engineer, program manager, regulatory programs specialist, quality control analyst); leadership team has experience scaling programs from research to commercial supply across multiple modalities

## Competitive Advantages
- **Modality-agnostic design**: Built to handle the full breadth of cell and gene therapy fields – ex-vivo, in-vivo, viral vectors, and synthetic biology – all under one roof.
- **Integrated platform**: Offers one continuous handoff from genetic design and R&D through IND-enabling, clinical, and commercial supply, minimizing vendor handoffs.
- **Co-development approach**: Positions itself as a co-development team with deep innovator-side experience rather than a transactional vendor.
- **New purpose-built facility**: Brand-new 2023 cGMP facility designed specifically for cell and gene therapy, with validated equipment and modern aseptic processing.
- **Leadership track record**: Senior leadership has commercial-scale experience and a clear roadmap to take partner programs through clinical trials and BLA.

## Strategic Focus
- Expanding cGMP manufacturing capacity (future 92K sq ft) to support commercial supply.
- Implementing digital quality systems (2026–2027) to achieve FDA pre-approval inspection readiness.
- Continuing to build a team of scientists, engineers, and operators to support partner programs from early-stage through commercial launch.

## Why Work Here
- **Culture**: Mission-driven environment focused on bringing breakthrough cell and gene therapies to patients. Described as "a team of scientists, engineers, and operators building the CDMO we always wished existed."
- **Work policy**: All listed current openings are on-site in Alameda, CA; some roles operate on 4x10 shift schedules.
- **Growth opportunity**: Join a young CDMO (founded 2023) with ambitions to scale from clinical to commercial supply, offering potential for career advancement as the company expands.
- **State-of-the-art facility**: Work in a new, purpose-built cGMP facility with modern equipment and cleanrooms.
- **Impact**: Directly contribute to the development and manufacturing of life-changing genetic medicines.

## Sources
1. [genefab.com](https://www.genefab.com/)
2. [genefab.com/about](https://www.genefab.com/about.html)
3. [genefab.com/careers](https://www.genefab.com/careers.html)
4. [genefab.com/team](https://www.genefab.com/team.html)
5. [jobs.lever.co/genefab](https://jobs.lever.co/genefab)

## Other roles at GeneFab

- [Program Manager, CRDMO](https://feeny.ai/job/program-manager-crdmo-genefab-alameda-fw0njn9asgrp) — Alameda, CA
- [Senior Specialist, Regulatory Programs (Part-Time)](https://feeny.ai/job/senior-specialist-regulatory-programs-part-time-genefab-alameda-wjq5195mkaqg) — Alameda, CA
- [Senior Manufacturing Engineer](https://feeny.ai/job/senior-manufacturing-engineer-genefab-alameda-6zbjev6nm675) — Alameda, CA
- [Bioprocess Specialist - CONTRACT](https://feeny.ai/job/bioprocess-specialist-contract-genefab-alameda-svf09yk8b26f) — Alameda, CA