Senior Advisor – Viral Vector Formulation & Drug Product Development

Eli Lilly and Company; Boston (MA); On-site; USD 141,000 - 231,000; Full time

Benefits offered by this job

Bonus program

401(k) plan

Vacation benefits

Job summary

Lilly in Boston seeks an experienced leader for lentiviral vector formulation and drug product development. The role focuses on in vivo CAR-T programs, formulation optimization, and technology transfer to internal or external manufacturing partners.

You will guide regulatory interactions and mentor junior staff in a collaborative, multi-disciplinary environment. The candidate will shape strategies across early to late-stage development, manage risks, and ensure robust, scalable processes aligned

Qualifications

• Ph.D. in Pharmaceutical Sciences or related field with 5+ years industry experience.
• Experience in formulation, drug product, fill-finish, and/or process development for viral vectors.
• Experience with technology transfer and GMP manufacturing.
• Strong cross-functional collaboration and communication skills.

Responsibilities

• Define and lead drug product development strategies across multiple in vivo CAR-T programs.
• Lead formulation development and optimization for viral vector products.
• Oversee drug product process development including fill-finish and container closure.
• Develop phase-appropriate manufacturing processes and scale-down models.
• Lead technology transfer to internal sites or CDMOs and support regulatory interactions.
• Contribute to regulatory submissions (INDs, IMPDs, BLAs, MAAs) and health authority responses.
• Mentor scientists and engineers and build capabilities within the organization.

Skills

Formulation development

Drug product development

Lentiviral vector development

Technology transfer

Regulatory submissions (INDs/BLAs/MAAs

Cross-functional collaboration

Education

Ph.D. in Pharmaceutical Sciences or related field

Master's degree with 10+ years of industry experience

Bachelor's degree with 15+ years of industry experience

Tools

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 Cell and Gene Therapy (CGT) Development organization within Bioproduct Research and Development (BR&D) leads Lilly’s cell and gene therapy portfolio from early clinical development through commercialization. The group’s current focus includes AAV, RNA, in vivo CAR-T, vaccines, and cell therapies and serves as a primary interface with Manufacturing and Clinical Development.

As part of Lilly’s strategic dedication to growing its gene therapy portfolio, we are seeking an experienced leader in lentiviral vector (LVV) formulation and drug product development. Based in Boston, MA, this role provides access to Lilly’s broad pharmaceutical development and engineering capabilities and its CGT network spanning discovery through commercialization.

We are seeking an experienced scientist to provide technical leadership in lentiviral vector formulation and drug product development. The successful candidate will have a strong understanding of viral vector formulation, fill-finish process development, and technology transfer for early- and late-stage products.

This role provides an opportunity to define and lead drug product development strategies across multiple in vivo CAR-T programs, advance the clinical pipeline, and provide scientific leadership and mentorship within a highly collaborative, cross-functional environment.

Key Objectives/Deliverables

• 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.

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

$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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