Scientist II​/Senior Scientist , Drug Product & Downstream Development; Viral Vectors

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

Azalea Therapeutics 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.

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

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…