Director/Senior Director, CMC, Drug Product Development

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Job Summary

The Director/Senior Director, CMC, Drug Product Development will lead formulation development activities across multiple dosage forms and therapeutic modalities, with a focus on developing and incorporating digital solutions and tools into drug product workflows. The ideal candidate will bring expertise in both parenteral and solid oral dosage forms, combined with emerging capabilities in computational and AI-driven formulation approaches.  Success in this role requires cross-function collaboration and leadership as well as a strategic vision for how technology can be leveraged to transform traditional drug development activities. 

Key Responsibilities

Formulation Development

• Lead formulation design, development and external manufacturing for both parenteral (IV, SC, IM) and solid oral (tablets, capsules) drug products across diverse therapeutic programs and modalities
• Develop robust formulation strategies that address in vivo performance, stability, bioavailability, manufacturability, and patient-centric considerations
• Manage a network of external providers (CROs, CDMOs) with capabilities in drug product development and manufacturing
• Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and manufacturing
• Support regulatory interactions and respond to health authority questions
• Ensure compliance with cGMP standards and ICH guidelines

Digital Solution Development

• Lead the development, testing and implementation of digital solutions related to drug product development
• Partner with IT and other internal drug product subject matter experts to translate drug product workflows into requirements that can be incorporated into technology solutions
• Lead the evaluation of in silico modeling tools and AI/ML platforms that predict formulation performance and accelerate development timelines
• Continuously monitor the industry trends, competitive landscape and emerging technologies to identify future tools and technology platforms of interest

Minimum Requirements

• Education: PhD in Pharmaceutical Science or related field (Chemistry, Chemical Engineering, Pharmacy)
• 8+ years of pharmaceutical industry experience
• 3+ years of prior experience with application of in silico tools or AI/ML solutions in drug product development

Additional Skills/Preferences

• Experience working with multiple therapeutic modalities (small molecules, biologics, peptides, oligonucleotides)
• Experience with both parenteral and solid oral formulations
• Knowledge of emerging modalities including cell & gene therapy, RNA-based medicines
• Strong analytical and problem-solving skills
• Experience working with biotechs/emerging companies and/or early-stage development programs where speed to clinic is a critical success factor
• Demonstrated ability to operate effectively in fast-paced environments where rapid decision-making and pragmatic problem-solving are essential to maintain program momentum
• Track record of supporting multiple concurrent programs with varying levels of technical maturity, demonstrating agility in shifting priorities and creative approaches to address emerging challenges

Additional Information

• Remote options may be considered based on business needs
• Travel up to 10%

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$148,500 - $257,400

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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