Principal Engineer I/II, MSAT / Viral Vector Downstream

Azalea Therapeutics, Inc. • Berkeley, CA

3h • $170,000 - $215,000 • Onsite

About The Position

Azalea is seeking a Principal Engineer I/II, Manufacturing Science and Technology (MSAT) - Viral Vector Downstream to serve as the senior technical lead for downstream viral vector technology transfer, and manufacturing readiness. Reporting to the VP of External CMC Operations, the immediate focus for this role will be advancing the EDV and AAV manufacturing capabilities required to move pipeline programs toward first-in-human readiness, including pilot runs, engineering runs, and initiation of GMP manufacturing.

This is a senior individual-contributor role aligned with Azalea’s Principal Scientist I/II levels. The Principal Engineer will be accountable for the technical direction of a major manufacturing area, not only the execution of assigned activities. This person will work closely with the internal process development teams to define priorities, connect downstream process decisions to program and company goals, provide technical leadership across external manufacturing partners, mentor other contributors, and influence cross-functional decisions with limited oversight.

The ideal candidate is a hands-on downstream process expert who can move between detailed data analysis and broader CMC strategy. This person should be comfortable leading through influence in a lean, externally networked organization, making clear recommendations with incomplete information, and balancing speed, quality, manufacturability, regulatory expectations, and patient-focused progress.They will be responsible for managing the technology transfer of our EDV and AAV manufacturing processes to our external manufacturing partners for the current and future programs. This is a full-time onsite position at our Headquarters in Berkeley, CA. The incumbent will travel and be onsite at the CDMO during manufacturing.

Requirements

• Bachelor’s degree in chemical engineering, biochemical engineering, bioengineering, biotechnology, or a related discipline with 12+ years of relevant experience; Master’s degree with 10+ years; or PhD with 8+ years. Equivalent combinations of education and experience will be considered.
• Skilled in downstream processing, MSAT, or manufacturing technical support for viral vectors, gene therapies, vaccines, or complex biologics. Direct viral vector experience is required.
• 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.

Nice To Haves

• 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.

Responsibilities

• Define and lead the external downstream process strategy for Azalea’s viral vector programs, with an immediate focus on EDV and AAV manufacturing for Program 1.
• In collaboration with the PD team, assist with downstream process development, optimization, scale-up, and manufacturing readiness activities across clarification, filtration, chromatography, ultrafiltration/diafiltration, formulation interfaces, sterile filtration, hold-time strategy, and other relevant unit operations.
• Establish phase-appropriate process understanding and control strategies, including identification of critical quality attributes, critical process parameters, key material attributes, process risks, and appropriate monitoring approaches.
• Own downstream technology transfer to contract development and manufacturing organizations (CDMOs), including transfer plans, process descriptions, protocols, batch records, training, readiness assessments, and transfer acceptance criteria.
• Provide technical leadership for pilot, engineering, and GMP manufacturing runs. Review data in real time, identify trends or emerging risks, troubleshoot complex process issues, and drive clear decisions and follow-up actions.
• Lead or support investigations of process deviations, manufacturing failures, atypical results, and recurring performance issues. Develop scientifically sound root-cause hypotheses, corrective actions, and risk-reduction plans in partnership with Quality and external manufacturers.
• Work collaboratively with internal PD teams to establish scale-down models that can be used for, process characterization, comparability, and other studies appropriate to Azalea’s development stage and program needs.
• Partner closely with Analytical Development and Quality Control teams to define in-process controls, sampling plans, analytical needs, acceptance criteria, and the data required to support process decisions and product release.
• Collaborate with Process Development, Formulation, Quality, Regulatory, Supply Chain, Program Management, Research, and other technical partners to align external manufacturing with integrated CMC and company milestones.
• Provide technical oversight of external partners, including scope definition, timeline management, technical review, issue escalation, and assessment of partner capabilities and performance.
• Contribute to CMC regulatory strategy, technical documentation, health-authority briefing materials, IND-enabling content, and responses related to downstream manufacturing and process control.
• Work with the internal and external process development team to evaluate new technologies, process improvements, and manufacturing approaches that may improve yield, purity, robustness, scalability, cycle time, cost, or long-term platform capability, with a concise objective of decreasing COGs.
• Model Azalea’s operating principles by owning outcomes, raising risks early, communicating recommendations directly, collaborating across functions, and maintaining high standards with low ego.

Benefits

• Eligible for annual performance bonuses
• Equity grants
• Comprehensive benefits package that includes medical, dental, vision, retirement plan with company match, and paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal