Senior Advisor, Bioassay Development — Analytical Development

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

Benefits offered by this job

401(k) plan

Medical, dental, vision benefits

Paid time off

Career development programs

Job summary

Lilly is seeking an accomplished Senior Advisor for bioassay development to lead the analytics strategy for RNA-LNP programs within ADS. You will direct bench scientists, serve as SME for cell-based potency assays, and partner across Research, Process and Formulation, and Quality to advance analytical strategies from research to manufacturing.

The role requires hands-on bench skills, leadership, and a strong track record in bioassay/potency assay development and regulatory awareness.

Qualifications

• PhD or equivalent with bioassay experience.
• Hands-on development of cell-based potency assays.
• Experience with flow cytometry, qPCR/ddPCR and ELISA.
• Knowledge of ICH/FDA guidelines for bioassays.
• Experience transferring assays to internal/external labs.

Responsibilities

• Define and execute bioassay strategy and roadmap.
• Lead end-to-end development and transfer of cell-based potency assays.
• Design and implement cellular and molecular assays including flow cytometry, qPCR/ddPCR, and ELISA.
• Represent bioassay on cross-functional project teams and act as SME for potency topics.
• Establish assay comparability and bridging across changes; apply DOE to reduce variability.
• Ensure analytical strategies meet regulatory expectations and enable transitions from research to manufacturing.

Skills

Bioassay development

Cell-based potency assays

Flow cytometry

qPCR/ddPCR

ELISA

Education

PhD in molecular biology/biochemistry

MS with 10+ years experience

Tools

CDMOs collaboration

DOE design

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.

Position Summary We are seeking an accomplished Senior Advisor for bioassay development within the Analytical Development (AD) team, supporting next‑generation RNA‑LNP‑based therapies within the Advanced Delivery Systems (ADS) organization. This individual will lead bioassay scientists and serve as the technical SME for cell‑based potency assays and other bioassays (e.g., flow cytometry, qPCR, ELISA) to characterize RNA‑LNP drug product and other drug delivery systems. The successful candidate will combine deep, hands‑on bioassay expertise with strategic leadership, partnering closely with Lilly Genetic Medicines, Process and Formulation, Cell and Gene Therapy, and Quality teams to drive phase‑appropriate analytical strategies and assay execution. The successful candidate will be self‑motivated, independent, have hands‑on bench skills, and able to lead and develop other scientist.

Key Responsibilities

• Serve as the technical lead and group leader for the bioassay function within Analytical Development, defining and executing bioassay strategy and roadmap for RNA‑LNP‑based programs.
• Lead end‑to‑end development, optimization, pre‑qualification, and technical transfer of cell‑based potency assays (e.g., transduction/transfection, cell‑based potency assays, functional reporter) as the primary measure of product potency.
• Design, develop, and execute cellular and molecular assays — including flow cytometry, qPCR/ddPCR, and ELISA‑based methods — to characterize RNA‑LNP drug product and process‑and product‑related impurities.
• Represent the bioassay function on cross‑functional project teams and in technical review settings, and act as the primary analytical SME for potency and bioassay topics.
• Establish assay comparability and bridging strategies across process/formulation changes, scale‑up, and method transfers; apply sound statistical design (e.g., DOE) to reduce variability and improve assay robustness.
• Partner closely with Research, Process and Formulation, Bioproduct Research and Development, Quality, and Regulatory teams to ensure integrated, phase‑appropriate analytical strategies, define CQAs, and assess assay suitability and readiness for research‑to‑development‑to‑manufacturing transitions.
• Oversee technology transfer of bioassays to internal analytical teams, CDMOs, and external testing laboratories, providing technical oversight for specification development.
• Evaluate and implement innovative bioassay platforms (e.g., next‑generation potency and multiplex flow and d‑PCR methods) to address emerging scientific and regulatory challenges.
• Ensure bioassay data, methods, and practices comply with ICH/FDA guidelines and industry best practices for cell and gene therapies.
• Identify and manage external collaborations (CROs/CDMOs) to enhance internal capabilities and drive bioassay innovation.
• Author and review assay protocols, technical reports, and relevant sections of regulatory submissions.

Basic Qualifications

• PhD in molecular biology, biochemistry, or a related discipline with 4+ years of industry experience in bioassay/potency assay development;
• or MS with 10 years of relevant experiences;
• Extensive, hands‑on experience developing, optimizing, and qualifying cell‑based potency assays (cell transfection, antigen detection, cell killing);
• Demonstrated hands‑on experience with other bioassay techniques such as flow cytometry, qPCR/ddPCR and ELISA;
• Knowledge of ICH/FDA guidelines and industry best practices related to bioassays and analytical methods for cell and gene therapies;
• Proven experience defining and executing phase‑appropriate assay strategies, including method transfer to internal and/or external (CDMO) labs.

Additional Skills and Preferences

• Prior experience characterizing RNA‑LNP based genetic medicines, process‑and product‑related impurities.
• Experience with PBMC or engineered immune cell lines to measure T‑cell activation and functional potency.
• Experience authoring regulatory submission sections and supporting health authority interactions.
• Strong critical thinking, communication, and problem‑solving skills, with an ability to influence scientific direction and deliver in a matrixed, fast‑paced environment.
• Ability to manage external collaborations and deliver quality results within a stringent timeline.

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).

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.

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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly