Advisor, Downstream Process Development – Viral Vectors

BioSpace; Boston (MA); On-site; USD 138,000 - 202,400; Full time

Benefits offered by this job

Company bonus

401(k) program

Health benefits

Vacation benefits

Well-being program

Job summary

Lilly is seeking a highly skilled scientist to lead downstream process development for AAV gene therapy products. The role spans from early development to GMP manufacturing and regulatory submission, collaborating across analytical, regulatory, and manufacturing teams to ensure robust, scalable processes.

The successful candidate will design DSP experiments, develop novel purification strategies, and model performance to accelerate scale-up, while mentoring junior scientists and contributing to

Qualifications

• Ph.D. or M.S. with substantial downstream process development experience for biologics or gene therapy.
• Proficiency with protein purification techniques and chromatography methods.
• Experience with statistical DOE and data analysis tools.

Responsibilities

• Design and execute downstream process development experiments for AAV purification.
• Develop and implement novel AAV purification strategies and DSP operating principles.
• Model column performance to guide scale-up and condition optimization.
• Collaborate with cross-functional teams for tech transfer and GMP manufacturing.
• Present findings and contribute to publications and filings.
• Author process descriptions, batch records, and CMC sections of IND/BLA filings.
• Mentor junior scientists and foster continual improvement.

Skills

AAV purification

Chromatography

UF/DF

Data analysis

DOE statistics

Python/MATLAB

Viral vector biology

Education

Ph.D. in Chemical/Biochemical/Bioengineering

M.S. in Chemical/Biochemical/Bioengineering

Tools

JMP

Minitab

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Downstream Process Development team is seeking a highly motivated scientist to drive innovation in viral vector purification. The successful candidate will lead platform development to advance DSP capabilities for recombinant adeno-associated virus (AAV) gene therapy products, supporting programs from early development through GMP manufacturing and regulatory submission; collaborating with Analytical Development, CMC Regulatory, and MFG to deliver robust, scalable and efficient manufacturing processes.

Key Responsibilities

• Design and execute downstream process development experiments for AAV purification, including affinity capture, ion-exchange chromatography, ultrafiltration/diafiltration, viral filtration, and ultracentrifugation
• Develop and implement novel AAV purification strategies; establish DSP operating principles and process understanding across diverse serotypes.
• Develop and apply mechanistic chromatography models to predict column performance, guide operating condition selection, and accelerate scale-up decisions, enabling rapid initiation of new gene therapy programs.
• Collaborate cross-functionally with upstream process development, analytical development, manufacturing, and quality teams to ensure seamless technology transfer and successful clinical manufacturing.
• Present experimental findings at internal team meetings, cross-functional reviews, and external conferences; contribute to scientific publications and patent applications as appropriate.
• Author and review technical documents including process descriptions, batch records, process characterization reports, and CMC sections of IND/BLA filings.
• Mentor junior scientists, encouraging a culture of scientific excellence and continuous improvement.

Basic Qualifications

• Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, or a related scientific discipline with 2+ years of relevant experience in downstream process development for biologics or gene therapy products, OR M.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, or a related scientific discipline with 10+ years of relevant industry experience
• Extensive hands-on experience with various protein purification techniques: chromatography (affinity, ion exchange, HIC) and membrane-based separations (UF/DF, depth filtration).
• Proficiency in statistical design of experiments (JMP, Minitab) and data analysis.

Preferred Qualifications

• Experience with recombinant AAV or other viral vector purification (lentivirus, adenovirus).
• Experience with automation platforms for HTP process screening
• Proficiency in Python and/or MATLAB for data analysis, model implementation, and automation scripting
• Knowledge of machine learning / multivariate analysis applied to bioprocess data
• Strong understanding of viral vector biology, expression systems, and analytical methods used for viral vector characterization.
• Excellent problem-solving skills, critical thinking, and ability to work independently and as part of a team.
• Strong written and verbal communication skills with the ability to effectively present complex scientific information.
• Adaptability in a fast-paced environment

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$138,000 - $202,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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