--- title: 'Bioprocess Specialist - CONTRACT at GeneFab' canonical: 'https://feeny.ai/job/bioprocess-specialist-contract-genefab-alameda-svf09yk8b26f' type: 'job' last_seen: '2026-09-11' --- # Bioprocess Specialist - CONTRACT at GeneFab - **Company:** GeneFab - **Location:** Alameda, CA - **Compensation:** $40–$50/hr - **Employment:** temporary - **Work type:** onsite - **Posted:** 2026-02-18 - **Last confirmed live:** 2026-09-11 - **Apply:** https://jobs.lever.co/genefab/af1f4bca-4940-40b8-85a6-e6a8b19f2276 ## Job description The Bioprocess Specialist II plays a critical role in the cell and gene therapy manufacturing processes at GeneFab. This position involves executing both upstream and downstream processes in a GMP-compliant cleanroom environment, with responsibility for troubleshooting, deviation management, training, and contributing to 5S and other improvement initiatives with the goal of ensuring on time delivery and right first-time execution of Manufacturing batches. You will collaborate with Operations, MSAT, Quality, and Facilities teams to ensure consistent production outcomes. Responsibilities: - Technical proficiency in aseptic techniques working with manufacturing equipment/instruments in open and closed systems - Organize, coordinate, and lead production activities and ensure execution of processes in production while strictly adhering to cGMP standards - Accurately complete batch records, forms, and documentation in line with Good Documentation Practices (GDP). - Work as part of a team to support the execution of daily GMP manufacturing activities. - Train staff in processing methods, aseptic technique, and cGMP clean room operations. - Review batch production records for completeness, accuracy, and to ensure cGMPs and Good Documentation Practices. - Initiate and support the closure of Deviation Reports and CAPAs - Other duties as assigned by management. Qualifications: - Minimum High School diploma or equivalent experience is required. Associates or higher degree in Biology, Life Science, or Engineering is preferred. - 3-4 minimum years of experience in biotech or pharmaceutical manufacturing, preferably in a cleanroom environment. - Familiarity with cGMP standards and basic understanding of Good Documentation Practices. - Proficiency working in cGMP cleanrooms and aseptic techniques - Advanced understanding of pipetting and micro pipetting. - Demonstrated ability to identify, challenge, and implement potential improvements to work procedures. - Ability to work flexible hours, including nights and weekends, as schedules may shift in this start-up environment. - Ability to stand for extended periods and lift up to 20 pounds. - Strong communication and teamwork skills, with a willingness to learn. ## 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 Analyst, Quality Control Analytical](https://feeny.ai/job/senior-analyst-quality-control-analytical-genefab-alameda-ztpns2g1kxer) — Alameda, CA - [Senior Manufacturing Engineer](https://feeny.ai/job/senior-manufacturing-engineer-genefab-alameda-6zbjev6nm675) — Alameda, CA