Advisor, Analytical Development - Gene Therapy

Advisor, Analytical Development

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.

We are seeking an Advisor to serve as a technical lead within the Analytical Development team at Lilly Harborside Labs, supporting AAV based gene therapy programs. This individual will lead analytical method development, qualification, and CMC regulatory strategy across multiple assets, while also providing leadership to scientists and oversight of routine testing in a development environment. The successful candidate will bring deep, hands on analytical expertise, demonstrated mastery of cell based assay development, and the ability to operate with significant technical independence and cross functional influence.

• Lead the design, development, optimization, and qualification of analytical methods for AAV drug substance and drug product, with particular emphasis on cell based potency and activity assays.
• Develop and apply molecular biology based methods (such as qPCR and ddPCR) and separation based methods (such as chromatographic and electrophoretic techniques) for product characterization and release.
• Lead and manage scientists, providing technical direction, development, and oversight within the analytical development team.
• Oversee routine analytical testing in a development environment, ensuring data quality, throughput, and adherence to procedures.
• Independently drive complex method development and troubleshooting, making sound technical decisions with limited oversight.
• Author and review CMC regulatory content for Module 3 submissions, including analytical procedure, validation, specification, and stability sections.
• Coordinate method execution and GMP testing with external CROs, ensuring data quality, protocol adherence, and timely delivery.
• Partner cross functionally with toxicology, quality, formulations, and manufacturing to align analytical strategy with program needs.
• Serve as a subject matter expert in analytical reviews, investigations, and qualification report assessments.

• PhD in analytical chemistry, biochemistry, molecular biology, or a related field with 2+ years industry experience; or a Master's degree in analytical chemistry, biochemistry, molecular biology, or a related field with 8+ years industry experience.
• Demonstrated, hands on experience developing cell based assays from scratch, including assay design, optimization, and qualification.
• Demonstrated experience leading and managing scientists, and overseeing routine testing in a development environment.
• Good foundation in GMP analytical method development and qualification for biologics or advanced therapies.
• Demonstrated experience authoring CMC regulatory documentation.

• Direct experience with AAV gene therapy or other viral vector modalities.
• Familiarity with compendial requirements (USP, Ph. Eur.) and ICH guidance relevant to analytical method validation.
• Experience leading analytical work through external CRO partnerships.
• Excellent communication skills, with the ability to clearly articulate complex analytical concepts to varied technical and cross functional audiences.

• This is a laboratory based role at Lilly Harborside Labs in Boston, MA.

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