Senior Scientist, Viral Vector Drug Product & Downstream

Valid8 Financial, Inc.; Berkeley (CA); On-site; USD 125,000 - 170,000; Full time

Benefits offered by this job

Bonus/Equity Eligible

Job summary

Azalea Therapeutics, based in Berkeley, CA, seeks a Scientist II/Senior Scientist I, Drug Product & Downstream Development (Viral Vectors) to lead formulation, stability studies, and fill‑finish development for viral vector programs. This on‑site role reports to the VP Process Development and requires close collaboration with manufacturing and quality teams.

The candidate will oversee stability and in‑use studies, buffer optimization, and tech transfer activities, contributing to CMC strategy

Qualifications

• PhD in Chemical Engineering, Bioengineering, Pharmaceutics, Biochemistry, Biomedical Engineering or a related scientific discipline field with 2+ years of relevant industry experience.
• Direct industry experience supporting drug product development for biologics, viral vectors, gene therapies, or related advanced therapeutic modalities.
• Deep practical expertise in filtration optimization and scale‑down modeling for sensitive biologics.
• Strong understanding of protein or viral vector stability mechanisms including aggregation, adsorption, oxidation, shear sensitivity, freeze‑thaw effects, and degradation pathways.
• Demonstrated expertise designing and executing formulation optimization studies using statistically designed experiments (DoE).
• Demonstrated ability to independently design experiments, interpret complex data, troubleshoot technical challenges, and make scientifically sound recommendations.
• Act as technical mentoring, coaching scientists on study design, data interpretation, and scientific decision making
• Strong scientific communication skills with demonstrated ability to present data to multidisciplinary technical teams.
• Experience working effectively in a fast‑paced, collaborative, start‑up biotechnology environment.

Responsibilities

• Stability & In-use Study Leadership: Design, execute, and interpret multiple internal stability studies (real-time, accelerated, stress, freeze/thaw, hold-time) and lead in-use compatibility assessments.
• Formulation & Buffer Development: Develop and optimize formulation buffers/excipients to maintain viral vector potency and quality through processing, storage, and use using DoE approaches.
• Mechanistic Understanding: Investigate mechanisms of viral vector loss of function (aggregation, adsorption, shear/air–liquid interface effects) and propose mitigation strategies.
• Filtration Expertise: Lead selection and optimization of filtration strategies, evaluating media, flux limits, and product loss to generate robust scale-down models.
• Technology Transfer: Collaborate with CDMO’s to optimize and improve drug product manufacturing processes, support scale up, and contribute to in process control strategies; provide technical support for GMP manufacturing activities such as serving as “person-in-plant” during manufacturing campaigns, providing technical representation, troubleshooting, and authoring tech transfer documentation.
• Cross-functional Collaboration: Partner with Analytical Development/Quality Control, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain teams and also present actionable recommendations to CMC leadership.
• Core Competencies: Scientific rigor, hands‑on experimentation, root‑cause problem solving, cross-functional communication, comfort in plant/GMP settings, and strong technical judgment under time constraints.

Job description

Azalea Therapeutics, based in Berkeley, CA, seeks a Scientist II/Senior Scientist I, Drug Product & Downstream Development (Viral Vectors) to lead formulation, stability studies, and fill‑finish development for viral vector programs. This on‑site role reports to the VP Process Development and requires close collaboration with manufacturing and quality teams.

The candidate will oversee stability and in‑use studies, buffer optimization, and tech transfer activities, contributing to CMC strategy