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

About the role

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

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.

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.

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.
• 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.