Sr. Advisor - Analytical Development

Initial Therapeutics, Inc.; Boston (MA); On-site; USD 141,000 - 229,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Health/dental/vision coverage

Flexible spending accounts

Job summary

Lilly in Boston, MA seeks a Senior Advisor, Analytical Sciences to lead LVV bioassay and potency assay development across late-stage programs. You will guide analytical strategies, oversee method qualification/validation, and partner with Regulatory and Quality to align with FDA/EMA expectations.

You will mentor scientists, drive innovative analytics, and contribute to regulatory submissions and tech transfers while advancing a robust analytical platform for gene therapy.

Qualifications

• PhD in analytical chemistry, biochemistry, molecular biology, or related discipline with 5+ years of industry experience.
• Extensive hands-on experience developing, optimizing, qualifying, and validating LVV bioassays and cell-based potency assays.
• Experience with regulatory submissions and CMC support from early through late-stage development.

Responsibilities

• Define and execute analytical development and control strategies across the product lifecycle, serving as technical lead for development, clinical-stage, and late-stage/commercialization programs.
• Lead end-to-end development, optimization, qualification, and validation of LVV bioassays and potency assays (e.g., cell-based transduction/infectivity assays, functional reporter assays, titer methods).
• Drive potency assay comparability and bridging across process changes, manufacturing site transfers, and reference standard updates, applying DOE to reduce variability and improve robustness.
• Provide scientific guidance on product characterization, comparability, and control strategy, aligning potency strategy with FDA/EMA expectations.
• Lead development, optimization, and troubleshooting of methods across the LVV/gene therapy analytical panel (identity, purity, safety, impurities) and define lifecycle strategies.
• Partner with Operations and Quality on method transfer, including complex cell-based bioassays, for internal/external testing labs and oversee specification development.

Skills

LVV bioassay

Potency assays

Analytical development

DOE statistics

Regulatory submissions

Education

PhD in analytical chemistry/biochemistry/molecular biology

MS with 12+ years of industry experience

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, Analytical Sciences to provide scientific leadership for analytical development supporting our gene therapy pipeline, with a particular focus on late-stage lentiviral vector (LVV) bioassay and potency assay development. This individual will serve as the technical subject matter expert for assay development, characterization, qualification, validation, and lifecycle management — driving phase-appropriate analytical strategies from early development through late-stage, licensure, and commercial readiness.

The successful candidate will combine scientific excellence and strategic leadership, partnering closely with CMC, Research, Quality, Manufacturing, and external partners while mentoring scientists and strengthening analytical capabilities across the organization.

Responsibilities

Analytical Strategy & LVV Bioassay/Potency Leadership

• Define and execute analytical development and control strategies across the product lifecycle, serving as technical lead for development, clinical-stage, and late-stage/commercialization programs.
• Lead end-to-end development, optimization, qualification, and validation of LVV bioassays and potency assays (e.g., cell-based transduction/infectivity assays, functional reporter assays, titer methods), including matrix or multi-method potency strategies, assay orthogonality, and surrogate potency justification.
• Drive potency assay comparability and bridging across process changes, manufacturing site transfers, and reference standard updates, applying strong statistical design (e.g., DOE) to reduce variability and improve robustness.
• Provide scientific guidance on product characterization, comparability, and control strategy, and partner with Regulatory and Quality to align potency strategy with evolving FDA/EMA expectations for advanced therapies.

Method Lifecycle, Characterization & Technology

• Lead development, optimization, and troubleshooting of methods across the broader LVV/gene therapy analytical panel (identity, purity, safety, process-related impurities), and define qualification, validation, and lifecycle strategies with emphasis on bioassay/potency methods.
• Partner with Operations and Quality on successful method transfer, including complex cell-based bioassays, to internal and external testing laboratories, and provide technical oversight for specification development.
• Drive implementation of novel analytical technologies, including next-generation potency and bioassay platforms, and provide scientific oversight for data interpretation and technical investigations.

Leadership, Mentorship & Regulatory Engagement

• Mentor and develop scientists across the analytical organization, building bench strength in bioassay and potency assay science, and serve as the primary analytical SME in cross-functional and technical review settings.
• Author and review analytical/potency sections of regulatory submissions and technical reports, and support health authority interactions and inspections as an analytical SME.
• Provide scientific oversight of external analytical development activities and technology transfers, and maintain awareness of emerging technologies and regulatory expectations.

Basic Requirements

• PhD in analytical chemistry, biochemistry, molecular biology, pharmaceutical sciences, or a related discipline with 5+ years of industry experience; or MS with 12+ years of industry experience.
• Extensive, hands-on experience developing, optimizing, qualifying, and validating late-stage lentiviral vector bioassays and cell-based potency assays.
• Demonstrated expertise in analytical development within cell and gene therapy, biologics, viral vectors, or related advanced modalities, including method transfer to internal/external labs and CMC support from early through late-stage development.

Additional Preferences

• Recognized expertise in LVV bioassay/potency science (surrogate potency, matrix approaches, multi-attribute methods) and demonstrated success leading complex technical programs.
• Experience supporting regulatory filings and health authority interactions, including potency-related BLA/MAA sections and inspection readiness.
• Strong leadership, mentoring, and communication skills, with the ability to influence scientific direction across stakeholders and a commitment to scientific excellence and talent development.

Additional Details

• Position Location: Boston MA
• This role is a lab based position.

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 - $228,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

• 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)

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