--- title: 'Senior Specialist, Regulatory Programs (Part-Time) at GeneFab' canonical: 'https://feeny.ai/job/senior-specialist-regulatory-programs-part-time-genefab-alameda-wjq5195mkaqg' type: 'job' last_seen: '2026-09-11' --- # Senior Specialist, Regulatory Programs (Part-Time) at GeneFab - **Company:** GeneFab - **Location:** Alameda, CA - **Compensation:** $85–$95/hr - **Employment:** part-time - **Work type:** onsite - **Posted:** 2026-08-11 - **Last confirmed live:** 2026-09-11 - **Apply:** https://jobs.lever.co/genefab/86d1b694-95d9-4f7e-ae63-0392f6afa33e ## Job description We are seeking an experienced and dynamic Quality Regulatory Program Manager to lead our quality assurance regulatory initiatives. As the Program Manager, you will be responsible for ensuring compliance with regulatory requirements, maintaining high-quality standards in manufacturing processes, and driving continuous improvement initiatives to enhance product quality and patient safety. This key role will develop and implement regulatory strategies leading to successful registration and life-cycle management of complex products serving patients and clients. This role builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities. ## Responsibilities - Plan, prepare, and manage submissions to HAs including, INDs, NDA/BLA regulatory filings in strong collaboration with GeneFab’s clients. - Participate in regulatory interactions with HAs including managing preparation of briefing materials for HA meetings, preparing subject matter experts (SMEs), and ensuring appropriate follow-up. - Participate in negotiations with regulatory agencies to resolve and review issues and shepherd proactive interactions with regulators. - Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, program teams and senior management, as relevant - Prepare and manage GeneFab’s regulatory registrations and/or licenses (e.g., FDA, Oregon Board of Pharmacy). - Develop and implement a comprehensive quality assurance strategy aligned with the organization's goals and regulatory requirements. - Provide strategic direction and leadership to the Quality Assurance team, fostering a culture of quality excellence and continuous improvement. - Collaborate with cross-functional teams to integrate quality principles into all aspects of the pharmaceutical manufacturing process. - Foster a culture of quality and compliance by promoting awareness and understanding of quality principles throughout the organization. - Independently provide effective phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for clinical trial applications and marketing applications for projects. - Work in close collaboration with clients, consultants and/or CROs, as needed, to ensure appropriate interactions with HAs. - Manage the QA budget to ensure that resources are allocated appropriately and that all projects are completed on time and within budget. - All other duties as assigned. ## Requirements - Minimum of a bachelor’s degree, preferably in a scientific discipline. - A minimum of 10 years of experience in compliance, quality, and CDMO/CMO management with a focus on regulatory documentation and lifecycle management. - Minimum of 10 years of GMP/QA experience. - General knowledge of aseptic manufacturing processes. - Broad knowledge of FDA and international regulations related to GMPs and Biopharma. - Experience organizing and managing work responsibilities while working independently with minimal oversight. - Time and project management skills with the ability to multi-task and meet deadlines. - Excellent verbal and written communication skills. - Excellent interpersonal and customer service skills. - Excellent organizational skills and attention to detail. - Broad knowledge of FDA and international regulations related to GMPs and BioPharma. - Experience organizing and managing work responsibilities while working independently with minimal oversight. - Knowledge of GMP requirements and quality regulations within the Biopharma industry, backed by extensive experience in preparing for and successfully navigating inspections conducted by global regulatory agencies, including the FDA and EMA authorities. - Experience with drug substances and drug products is desired. - Knowledge of regulatory requirements across development stages and post-approval is essential. - Expert working knowledge of full drug development process and knowledge of FDA and ICH regulatory requirements. - Strong strategic and analytical abilities, diplomacy, and negotiation skills. - The ability to collaboratively influences multiple functions and motivates others to accomplish company objectives. - Self-motivated and detail oriented with sound judgement and innovative thinking to deal with challenges/opportunities. ## 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 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 - [Bioprocess Specialist - CONTRACT](https://feeny.ai/job/bioprocess-specialist-contract-genefab-alameda-svf09yk8b26f) — Alameda, CA