Director/Sr Director, Long-Acting Injectable & Bio-Nano Interface Characterization

BioSpace; Indianapolis (IN); On-site; USD 153,000 - 264,000; Full time

Job summary

Lilly in Indianapolis is seeking a Director/Sr Director for Long-Acting Injectable & Bio-Nano Interface Characterization to lead scientific strategy across LAI and depot delivery platforms, including bio‑nano interface studies and protein corona dynamics, with an emphasis on IND‑enabling and design controls.

The role requires a PhD and 8+ years in industry, strong leadership, and proven ability to mentor scientists, publish or patent work, and collaborate across CROs, academia, and regulatory

Qualifications

• PhD in pharmaceutical sciences, chemical or biomedical engineering, materials science, biophysics, or a related field.
• 8+ years in long-acting injectable/depot formulation and injectable nanoparticle development; deep release-rate engineering.
• Bridge preclinical mechanistic understanding to IND-enabling/translational plans.
• Working knowledge of design controls and quality systems.

Responsibilities

• Define the scientific vision and multi-year strategy for long-acting injectable and depot delivery.
• Serve as internal and external technical authority on injectable depot systems and bio-nano interface; lead cross-functional teams; leverage AI/ML modeling for decision making.
• Build external networks with academics, CDMOs, consortia, and regulatory bodies; present work in publications and regulatory discussions.
• Design and oversee preclinical release, PK/IVIVC, and biodistribution study strategy with CROs and academic partners; drive data-driven decisions.
• Mentor scientists and engineers; identify process improvements across the portfolio.

Skills

Leadership

AI/ML tools

Scientific communication

Mentoring

Cross-functional collaboration

Education

PhD in pharmaceutical sciences / chemical/biomedical engineering / materials science / biophysics

Tools

AI/ML modeling tools

biophysical characterization 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.

Organization Overview

The Drug Delivery group at Lilly studies physiological barriers across routes of administration to create novel, patient‑centric delivery solutions, serving as a center of excellence in injection physiology, device ideation, novel drug delivery technologies across modalities and routes of administration, nanomedicine and targeted delivery, and connected devices/digital biomarkers.

Position Overview

The Director/Sr Director, Long‑Acting Injectable & Bio‑Nano Interface Characterization anchors a growing technical capability in long‑acting injectable (LAI) and depot delivery — spanning polymer and lipid depot platforms (microspheres, in situ forming depots, and liquid‑crystal systems, etc.) together with the physicochemical and biological characterization of injectable particle systems, including protein‑corona (biocorona) formation at the bio‑nano interface — intended to extend dosing intervals, enable higher‑concentration and needle‑sparing delivery, and de‑risk the in vivo fate of injectable biologics, peptides, and nucleic‑acid medicines. We are seeking a senior technical leader to define and drive the scientific and translational strategy for these platforms at Lilly, operating at the enterprise level: setting technical direction across programs, representing Lilly externally with academic, clinical, CDMO, and regulatory stakeholders, and mentoring the next generation of scientists and engineers. The role carries accountability for translating long‑acting‑injectable and bio‑nano‑interface science from mechanistic understanding into IND‑and design‑control‑ready delivery platforms.

Key Responsibilities

• Define the scientific vision and multi‑year technical strategy for long‑acting injectable and depot delivery, aligned with the group’s portfolio bets and enterprise R&D priorities, including build‑vs‑buy and external innovation decisions (licensing, partnerships, sponsored research).
• Serve as Lilly’s internal and external technical authority on injectable depot systems and the bio‑nano interface — including release‑rate engineering, burst‑release control, and protein‑corona and biodistribution behavior; lead cross‑functional and cross‑company teams to translate platform concepts from feasibility through design control, leveraging AI/ML‑enabled modeling and data‑analysis tools to accelerate technical decision‑making.
• Build and leverage an external network of academic collaborators, CDMOs, consortia, and regulatory bodies (e.g., FDA); represent Lilly’s long‑acting‑injectable and nanoparticle‑characterization work in publications, conferences, and regulatory discussions.
• Design and oversee preclinical release, PK/IVIVC, and biodistribution study strategy with CRO and academic partners to de‑risk IND‑enabling and design‑control decisions; champion breakthrough approaches and make data‑driven, sometimes bold, decisions under scientific and technical ambiguity where no precedent exists.
• Actively mentor and coach scientists and engineers, including staff outside your direct reporting line; identify and help lead scientific or process improvements that draw on diverse thinking across DDCS’s broader technical portfolio.

Basic Qualifications

• Earned PhD in pharmaceutical sciences, chemical or biomedical engineering, materials science, biophysics, or a related field.
• 8+ years of relevant industry/translational experience in long‑acting injectable/depot formulation (must have) and injectable nanoparticle development, including: demonstrated depth in release‑rate engineering for polymer or lipid depot systems, and physicochemical characterization of nanoparticle systems.
• Demonstrated ability to bridge preclinical mechanistic understanding of injectable depot release and bio‑nano interactions — or a directly comparable physical delivery mechanism — into IND‑enabling or design‑control‑ready translational plans.
• Working knowledge of design controls and quality systems in a regulated industry.
• Effective, hands‑on use of AI/ML‑enabled tools to accelerate scientific research, technical writing, and translational planning.
• Proven ability to lead, mentor, and develop technical talent, including staff outside a direct reporting line.
• A publication and/or patent record demonstrating recognized technical contribution in long‑acting injectable or nanoparticle‑based drug delivery; and excellent scientific communication skills across technical/non‑technical and internal/external audiences.

Additional Preferences

• Experience with protein‑corona (biocorona) profiling — e.g., proteomics/LC-MS/MS of the biomolecular corona — and translating physicochemical attributes to in vivo biodistribution and PK
• Experience with sustained‑release device‑drug‑product integration (prefilled syringes, autoinjectors).
• Experience with complex characterization tools (e.g., IVIVC/PK modeling, AF4‑MALS, cryo‑EM/cryo‑TEM, or equivalent) is a plus but not required if compensated by deep mechanistic/biological expertise.

Other Information

• Hands‑on in‑Lab Requirement: 25‑50%
• Travel Percentage (%): 10‑15

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 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 $153,000 - $264,000 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.