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

Azalea Therapeutics•Berkeley, CA

6d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

Design, execute, and interpret multiple internal stability studies (real-time, accelerated, stress, freeze/thaw, hold-time) and lead in-use compatibility assessments.
Develop and optimize formulation buffers/excipients to maintain viral vector potency and quality through processing, storage, and use using DoE approaches.
Investigate mechanisms of viral vector loss of function (aggregation, adsorption, shear/air–liquid interface effects) and propose mitigation strategies.
Lead selection and optimization of filtration strategies, evaluating media, flux limits, and product loss to generate robust scale-down models.
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.
Partner with Analytical Development/Quality Control, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain teams and also present actionable recommendations to CMC leadership.