Principal Engineer III, MSAT Viral Vector Downstream

Job Title: Principal Engineer I/II MSAT / Viral Vector Downstream

Department: External CMC Operations
Reports to: VP of External CMC Operations
Location: Onsite 5 days per week at our Berkeley CA office
Employment Type: Full-time
FLSA Status: Exempt
Bonus/Equity: Eligible

About Azalea

Azalea Therapeutics is enabling precision genome engineering directly inside the body with an initial focus on creating cancer immunotherapiesin vivo. Azalea is pioneering a new way to turn a persons own T cells into a powerful cancer therapy directly inside the body. Instead of removing cells and manipulating them in a lab we use precision genome editing tools to engineer T cells where they already live. At the center of our approach are Enveloped Delivery Vehicles or EDVs. As highly selective couriers EDVs are designed to specifically locate T cells within the patient and deliver our genome engineering cargo. Once inside the cell the anti-cancer agent is inserted into a precise site in the genome ensuring safe and potent modifications to fortify the T cells against cancers.

Why this matters:

• We aim to make cell therapy faster and more accessible by avoiding complex manufacturing outside the body.

• Our platform is designed for precision so the right cells are safely programmed to effectively fight cancer.

• This technology has the potential to treat a wide range of cancers with a streamlined scalable process.

Our goal is simple:develop next-generation delivery technologies to bring genetic engineering and cell therapies to more patients.

How We Work

Azalea is building ambitious science in a fast-moving environment. The people who thrive here are accountable adaptable rigorous humble and direct. Across roles and functions we look for team members who demonstrate the following:

• Outcome Ownership - We own results close loops and follow through without needing to be prompted. We take responsibility for moving work forward and making sure important decisions deliverables and handoffs do not fall through the cracks.

• Comfort with Ambiguity - We operate in an early-stage environment where information may be incomplete and priorities may evolve. We clarify quickly make thoughtful decisions with the information available and adapt without unnecessary drama.

• High Standards Low Ego - We care deeply about the quality of the work and the impact it can have for patients. We raise the bar while staying humble direct and open to feedback.

• Collaboration and Candor - We share context early communicate clearly partner across functions and operate with transparency. We believe strong collaboration requires both trust and direct communication.

The Opportunity

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 Azaleas 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 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.

Key Responsibilities

• Define and lead the external downstream process strategy for Azaleas 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 Azaleas 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 Azaleas operating principles by owning outcomes raising risks early communicating recommendations directly collaborating across functions and maintaining high standards with low ego.

Qualifications

• Minimum Qualifications

  • Bachelors degree in chemical engineering biochemical engineering bioengineering biotechnology or a related discipline with 12 years of relevant experience; Masters 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.

• Preferred 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.

What Success Looks Like (first 36 months)

• Develops a strong understanding of Azaleas platform AZA-2509 program strategy EDV and AAV manufacturing processes external manufacturing network and 2026 company goals.

• Works collaboratively with our CDMO to complete a practical downstream manufacturing-readiness assessment that identifies the highest-priority technical gaps process risks data needs and decisions required for pilot engineering and GMP execution.

• Establishes an integrated downstream work plan with clear owners milestones dependencies and decision points aligned with AZA-2509 manufacturing timelines.

• Clarifies the phase-appropriate process control strategy including key quality attributes process parameters in-process controls sampling needs and escalation thresholds.

• Provides credible technical leadership during manufacturing planning and execution resolving priority issues quickly while maintaining scientific rigor and documentation quality.

• Contributes clear downstream manufacturing content to CMC planning regulatory materials and integrated program decisions.

• Becomes a trusted technical authority who improves decision quality raises standards and helps Azalea move complex manufacturing work forward with limited oversight.

• Ability to work in a hybrid environment with regular engagement with Bay Area-based colleagues laboratories and external partners.

• Ability to travel as needed to CDMOs testing laboratories manufacturing sites technical meetings and company business locations.

• Ability to work in laboratory or manufacturing environments as needed and comply with applicable safety gowning and personal protective equipment requirements.

• This role includes substantial computer-based technical work data review document preparation and virtual and in-person collaboration.

Working Conditions / Physical Requirements (as applicable)

• Travel 40% expected to be PIP for all GMP operations

• Ability to lift 50lbs and stand for at least 6-8 hours

Compensation and Benefits

• The expected salary range for this role based on the primary location for this position in California is $170000 - $215000 per year. Offer amounts are determined by factors such as experience qualifications geographic location and other job-related factors permitted by law. Salary will be commensurate with experience qualifications training and market.

• This role is eligible for annual performance bonuses equity grants and a comprehensive benefits package that includes medical dental vision retirement plan with company match and paid time off.

Azaleas Commitments

Equal Employment Opportunity (EEO): Azalea is an equal opportunity employer. We consider qualified applicants without regard to race color religion sex gender identity or expression sexual orientation national origin ancestry age disability medical condition genetic information marital status military or veteran status or any other characteristic protected by applicable law.

Reasonable Accommodation: We will provide reasonable accommodation to qualified individuals with disabilities and to individuals with sincerely held religious beliefs consistent with applicable law. To request accommodation email HR at HR email.

Applicant Privacy: Azalea collects and uses applicant personal information for recruiting and employment purposes. If applicable Azalea will provide a California applicant privacy notice describing categories of information collected purposes retention and rights under the California Consumer Privacy Act (CCPA/CPRA).

Job Description Disclaimer: This job description may change at any time based on business needs. It is not a contract and does not create a promise of employment for any particular duration.

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Information on Fraudulent Job Offers:Azalea is aware that some job seekers have received false employment offers or recruitment emails from individuals or organizations posing as Azalea. The individuals or organizations sending these false employment offers may send requests seeking to gain personal information items of value or monetary funds under the premise that doing so is required to further the recruitment process.

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Legitimate email communications from Azalea will also only use emails that end in @ from our core recruitment team. Fraudulent emails claiming to be sent by Azalea or Azalea employees may come from similar sounding emails with endings like @ or @ or even emails ending in common public domain addresses with endings like @ or @. There can also be instances of fraudulent communication that use the names and pictures of known company employees claiming to be sent from those employees or that even link out to fake websites that were created to look and feel like the real company website.

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