Scientist II/Senior Scientist I, Drug Product & Downstream Development (Viral Vectors)

Job Title: Scientist II/Senior Scientist I, Drug Product & Downstream Development (Viral Vectors) Department: Tech Ops Reports to: VP Process Development Location: Onsite 5 days per week in Berkeley, CA Employment Type: Full-time FLSA Status: Exempt Bonus/Equity: Eligible About Azalea Azalea is enabling precision genome engineering directly inside the body, with an initial focus on creating cancer immunotherapies in vivo . Azalea is pioneering a new way to turn a person’s 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 Therapeutics is seeking a highly motivated Scientist II/Senior Scientist I, Drug Product & Downstream Development (Viral Vectors) to join our growing team. Reporting to the VP of Process Development, this individual will play a key role in leading and executing formulation and fill-finish–enabling development for viral vector programs. This person will design and run internal stability and in-use compatibility studies, develop and optimize formulation buffers, and drive mechanistic understanding of viral vector loss of function across processing and storage. The role includes deep technical ownership of filtration strategy (selection, optimization, and scale translation) and the ability to serve as a “person-in-plant” during GMP formulation and fill activities, partnering closely with manufacturing and quality teams. The ideal candidate is a highly collaborative, hands-on scientist who enjoys designing experiments, solving complex technical challenges, and working cross-functionally with Analytical Development, Manufacturing, Quality, Regulatory, and external CDMO partners. This individual will serve as a technical subject matter expert during manufacturing campaigns, contribute to CMC strategy, and help build scalable processes that support the company’s rapidly growing pipeline. This is an excellent opportunity to join an early-stage biotechnology company developing next-generation cell and gene therapies while helping shape the future of drug product development. This role is located in our Berkeley office and is expected to be onsite 5 days/week. Key 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. Qualifications Minimum Qualifications PhD in Chemical Engineering, Bioengineering, Pharmaceutics, Biochemistry, Biomedical Engineering or a related scientific discipline field with 2+ years of relevant industry experience; or M.S. with 5+ 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. Preferred Qualifications Prior “person-in-plant” experience supporting GMP formulation, sterile filtration, or fill‑finish manufacturing operations at CDMOs. Experience developing lentiviral vector, AAV, adenoviral vector, or other viral vector drug products. Experience with container closure systems and single‑use assemblies. Hands‑on experience with analytical characterization techniques including vector titer assays, DLS, SEC, UV spectroscopy, particle analysis, or other stability‑indicating methods. Familiarity with CMC regulatory documentation and DoE statistical analysis tools including IND‑enabling activities, process characterization reports, and technical sections supporting regulatory submissions. Hands‑on experience with vector titer assays, DLS, and other stability‑indicating analytical tools. What Success Looks Like (first 3–6 months) Design and execute a comprehensive and repeatable internal playbook for stability and in-use compatibility studies. Deliver a data‑backed formulation buffer strategy that improves product stability, recovery, manufacturability and a clear risk register. Implement an optimized filtration approach that supports successful scale translation. Build strong cross‑functional relationships while becoming a trusted scientific resource within the CMC organization. Successfully support one or more GMP manufacturing campaigns as the technical drug product representative, effectively troubleshooting issues and partnering with CDMO teams. Working Conditions / Physical Requirements (as applicable) Ability to work in‑person at Azalea’s main laboratory space in Berkeley, CA Willingness to travel and work periodically to CDMO manufacturing facilities during GMP campaigns. Ability to sit and stand throughout the day to complete the job’s responsibilities. Compensation and Benefits The expected salary range for this role based on the primary location for this position in California is $125,000 - $170,000 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. 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 View email address on click.appcast.io. 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. #J-18808-Ljbffr Valid8 Financial, Inc.