Principal Engineer I/II, MSAT / Viral Vector Downstream
$170,000–$215,000 year
On-siteBerkeley, California, United States
Job Summary
Define and lead the external downstream process strategy for viral vector programs, focusing on EDV and AAV manufacturing readiness for Program 1. Collaborate with process development teams to optimize scale-up, technology transfer to CDMOs, and GMP execution, while providing technical oversight of partner capabilities and performance. Establish phase-appropriate control strategies, manage pilot and engineering runs, and lead investigations into process deviations. Partner with Quality, Regulatory, and Supply Chain teams to align manufacturing with IND-enabling milestones and company goals. This senior individual-contributor role requires onsite presence at the Berkeley, CA headquarters and travel to CDMOs, with a salary range of $170,000 - $215,000.
Required Qualifications
- Bachelor's degree in chemical engineering, biochemical engineering, bioengineering, biotechnology, or a related discipline
- 12+ years of relevant experience
- Master's degree with 10+ years
- PhD with 8+ years
- Equivalent combinations of education and experience
- Skilled in downstream processing, MSAT, or manufacturing technical support for viral vectors, gene therapies, vaccines, or complex biologics
- Direct viral vector experience
- Demonstrated success collaborating with the downstream process development teams through scale-up, to support technology transfer, engineering runs, and GMP manufacturing
- Strong technical depth in purification and recovery operations such as clarification, depth filtration, chromatography, ultrafiltration/diafiltration, sterile filtration, and process hold strategies
- Experience establishing process understanding and control strategies using risk assessments, critical quality attributes, critical process parameters, process trending, and data-driven decision-making
- Experience overseeing CDMOs or external manufacturing partners and holding technical teams accountable for quality, timing, documentation, and issue resolution
- Working knowledge of GMP expectations, phase-appropriate process validation, change control, deviation investigation, comparability, and relevant ICH and regulatory principles
- Strong analytical and troubleshooting capability, including the ability to integrate complex manufacturing and analytical data, distinguish facts from assumptions, and make clear technical recommendations
- Ability to communicate technical risks, tradeoffs, and decisions clearly to cross-functional teams, senior leaders, external partners, and regulatory contributors
- Location: Onsite 5 days per week at our Berkeley, CA office
- Employment Type: Full-time
- FLSA Status: Exempt
- Bonus/Equity: Eligible
Desired Qualifications
- Experience with upstream operations, such as transient transfection of bioreactors in a GMP environment for viral vectors, primarily Lenti and AAV
- Experience with AAV, lentiviral vectors, enveloped viral vectors, engineered delivery vehicles, or related gene-delivery modalities
- Has supported both internally developed processes and externally executed manufacturing in an early-stage biotechnology company
- History with design of experiments, multivariate analysis, statistical process evaluation, or process modeling
- Proven success developing process characterization, comparability, or validation strategies for clinical-stage products
- Has contributed to pre-IND or IND documentation, submissions, and health-authority interactions for viral vector or gene therapy programs
- Familiarity with upstream-downstream interfaces, formulation, analytical control strategies, raw-material risk, single-use systems, and manufacturing network design
- Demonstrated ability to mentor technical contributors and lead major workstreams through influence without relying on formal authority
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