Director/Sr Director, Analytical Development & Characterization

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 153,000 - 264,000; Full time

Benefits offered by this job

401(k) Plan

Pension

Vacation benefits

Medical, dental, vision coverage

Flexible benefits

Job summary

Lilly seeks a Senior Director/Director of Analytical Development & Characterization to define and lead the analytical science strategy for injectable biologics and complex delivery systems. You will oversee method development, validation, dissolution, and biophysical characterization, guiding IND-enabling decisions and cross-functional teams.

You will mentor scientists, collaborate with academia and CDMOs, and represent Lilly in regulatory discussions while advancing innovative analytics and

Qualifications

• Earned PhD in analytical chemistry, pharmaceutical sciences, chemistry, chemical engineering, or a related field.
• 8+ years of industry experience in pharmaceutical analytical development, including separation science and method development/validation.
• Bridge analytical method and characterization into IND/CMC-ready control strategies; knowledge of ICH Q2, design controls, and quality systems.
• Hands-on use of AI/ML-enabled tools to accelerate research and translational planning.
• Proven ability to lead, mentor, and develop technical talent; strong technical publication/patent record.

Responsibilities

• Define multi-year analytical development and characterization strategy for delivery-science platforms.
• Serve as internal/external technical authority on analytical development and translational work.
• Build external collaborations with academia, CDMOs, and regulators; represent Lilly externally.
• Oversee strategy for method, release, stability studies; drive data-driven decisions under ambiguity.
• Mentor scientists and engineers across teams; lead cross-functional improvements.

Skills

Analytical chemistry

HPLC/UPLC

LC-MS

IND/CMC strategies

AI/ML tools

Mentoring

Science communication

Education

PhD in analytical chemistry or related

Tools

HPLC/UPLC

LC-MS

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:

At Lilly, we serve an extraordinary purpose.We make a difference for peoplearound the globeby discovering,developingand delivering medicines that helpthemlive longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

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, Analytical Development & Characterization anchors the analytical development and characterization capability that underpins these platforms — spanning separation science and method development and validation (stability-indicating, impurity, potency, and identity methods), in vitro release and dissolution science for long-acting and controlled-release systems, and the physicochemical and biophysical characterization of complex injectable, particulate, and nanoparticle dosage forms (particle sizing, solution behavior, thermal and higher-order structural stability, and the bio-nano interface) — intended to define critical quality attributes, build phase-appropriate control strategies, and de-risk the translation of injectable biologics, peptides, and nucleic-acid medicines.

We are seeking a senior technical leader to define and drive the analytical scientific and translational strategy for these platforms at Lilly, operating at the enterprise level: setting technical direction across programs, representing Lilly externally with academic, CDMO, and regulatory stakeholders, and mentoring the next generation of scientists and engineers. The role carries accountability for translating delivery-science analytical understanding from method and characterization science into IND- and CMC-ready control strategies and delivery platforms.

Key Responsibilities:

• Define the scientific vision and multi-year technical strategy for analytical development and characterization across the delivery-science portfolio, 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 delivery-science analytical development — including chromatographic and orthogonal method development and validation, in vitro release/dissolution and IVIVC-enabling analytics, and physicochemical, biophysical, and bio‑nano‑interface characterization; lead cross-functional and cross-company teams to translate methods and control strategies from feasibility through design control and CMC, 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, USP/ICH standards efforts); represent Lilly’s analytical development and characterization work in publications, conferences, and regulatory or compendial discussions.

• Design and oversee analytical method, release-characterization, and stability study strategy with CRO/CDMO and academic partners to de-risk IND-enabling and CMC 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 analytical chemistry, pharmaceutical sciences, chemistry, chemical engineering, or a related field.

• 8+ years of relevant industry/translational experience in pharmaceutical analytical development, including demonstrated depth in separation science (HPLC/UPLC, LC-MS) and method development and validation (stability-indicating and impurity methods, and the definition of critical quality attributes and phase-appropriate control strategies).

• Demonstrated ability to bridge analytical method and characterization science — or a directly comparable analytical/CMC discipline — into IND-enabling or CMC-ready control strategies, supported by working knowledge of method validation (ICH Q2), design controls, and quality systems in a regulated industry

• Effective, hands‑on use of AI/ML-enabled tools (e.g., large language models, computational modeling copilots, literature-synthesis or data-analysis assistants) 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 analytical development or characterization science; and excellent scientific communication skills across technical/non-technical and internal/external audiences.

Additional Preferences:

• Experience building and sustaining external scientific relationships (academic labs, consortia, key opinion leaders); comfort representing an organization’s technical position externally.

• Experience with analytical development for complex or novel delivery systems (long-acting injectables/depots, nanoparticles/LNPs, high-concentration biologics, peptides, or transdermal systems), in vitro release/dissolution method development, or proteomics/LC-MS characterization of the nano-bio interface, is a plus but not required if compensated by deep analytical/method-development 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 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

$153,000 - $264,000

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

• 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)

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