Senior Advisor - Viral Vector Formulation & Drug Product Development

The responsibilities for this role will include

• Define and lead drug product development strategies across multiple in vivo CAR-T programs, establishing robust and scalable approaches that enable progression from early development through clinical and commercial manufacturing.
• Lead formulation development and optimization for viral vector drug products, with emphasis on product stability, potency, infectivity, manufacturability, and compatibility with the intended clinical presentation and route of administration.
• Lead drug product process development, including final filtration, fill-finish, container closure selection, and strategies for storage, shipping, and handling.
• Develop phase-appropriate manufacturing processes and representative scale-down models to support process characterization, technology transfer, comparability, and lifecycle management.
• Lead technology transfer to internal manufacturing sites and/or external CDMOs, serving as a key technical point of contact for formulation, fill-finish, and drug product manufacturing activities.
• Contribute to regulatory submissions, including INDs, IMPDs, BLAs, and MAAs, and support responses to health authority questions and regulatory interactions.
• Proactively communicate development strategy, technical risks, mitigation plans, and key decisions to program teams, governance bodies, and senior leadership.
• Provide scientific leadership and mentorship to scientists and engineers and contribute to building drug product development capabilities within the organization.
• Maintain awareness of emerging scientific literature, technologies, regulatory expectations, and manufacturing approaches relevant to viral vector formulation and drug product development.
• Identify and implement innovative technologies that improve product quality, process robustness, manufacturing efficiency, and speed to clinical and commercial supply.

Basic Qualifications

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, Biochemistry, Biology, or a related field with 5+ years of relevant industry experience; or a master's degree with 10+ years; or a bachelor's degree with 15+ years of relevant industry experience.
• Significant experience in formulation, drug product, fill-finish, and/or process development for viral vectors or other complex biologic products, with direct experience in lentiviral vector development.

Additional Skills and Preferences

• Demonstrated experience developing drug products across early and late stages of the product lifecycle, with experience supporting clinical development, GMP manufacturing; experience with process characterization, PPQ, and/or commercial readiness is preferred.
• Strong technical knowledge of formulation development, stability, final filtration, aseptic fill-finish processing, container closure systems, and drug product characterization.
• Knowledge of ex-vivo and in-vivo cell therapy, gene therapy, and genetic medicine delivery technologies and their associated drug product development challenges.
• Experience with technology transfer and manufacturing implementation, including transfer to internal GMP facilities and/or external CDMOs.
• Experience contributing to CMC regulatory strategy and documentation, such as INDs, IMPDs, BLAs, MAAs, or equivalent regulatory submissions.
• Experience with visible, subvisible, and submicron particle characterization and development of particle-control strategies for biologic or viral vector products.
• Demonstrated ability to lead complex technical programs and make science- and risk-based decisions in a multidisciplinary development environment.
• Strong cross-functional collaboration and communication skills, with the ability to communicate technical strategy, risks, and recommendations effectively to scientists, engineers, program teams, and senior leadership.
• Demonstrated ability to manage multiple programs and priorities in a dynamic development environment.
• Experience leading technical teams, mentoring and developing scientists and engineers.

Additional Information

• Travel: 0 to 15%
• This position's work environment is in a Laboratory onsite in Boston, MA.
• Potential exposure to chemicals, allergens, and loud noises.
• The physical demands of this job are consistent with a lab environment.

Additional information

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 $141,000 - $231,000

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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