Sr. Director-Purification and Viral Safety

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 156,000 - 228,800; Full time

Job summary

Lilly in Indianapolis, IN is seeking a Senior Director to lead the purification and viral safety CMC function for biologics. This role oversees downstream process development, scale-up, technology transfer, and regulatory submissions across monoclonal antibodies, AAV, and related bioproducts, partnering with Discovery, Manufacturing and Regulatory.

You will set strategy, drive innovation, manage resources, and mentor teams while integrating AI/ML tools to advance workflows.

Qualifications

• PhD or equivalent with extensive bioproduct development experience.
• Proven leadership of scientific teams and cross-functional collaboration.
• Strong communication and regulatory filing experience preferred.
• Experience driving innovation in downstream bioprocessing and viral safety.
• Familiarity with GMP and technology transfer activities.

Responsibilities

• Leads purification development and viral safety to enable scale-up and tech transfer.
• Sets strategic direction for the department to meet portfolio goals.
• Oversees adoption of emerging technologies and regulatory initiatives.
• Defines innovation roadmap aligned with Discovery and manufacturing needs.
• Manages resources and drives productivity through operational excellence.
• Leads AI/ML integration, process modeling, and high-throughput screening efforts.
• Develops talent and mentors staff at all levels.
• Oversees lab operations and scale-up facilities with safety focus.
• Collaborates across departments to ensure business effectiveness.

Skills

Leadership

Strategic thinking

Communication

Project management

AI/ML in bioprocessing

Education

Ph.D. in Chemistry, Biochemistry, Chemical Engineering

BS/MS with 18+ years experience

Tools

Technology transfer

High-throughput screening

Process modeling

Job description

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.

Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live 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.

Organization and Position Summary

Bioproduct Research and Development (BRD) is seeking a Senior Director to lead the purification and viral safety CMC function for biologics products. This position is accountable for downstream process development including scale‑up, viral clearance strategy, technology transfer, and regulatory submissions for a broad portfolio of bioproduct programs, including, but not limited to, monoclonal antibodies, bispecific antibodies, recombinant proteins, AAV, and bioconjugates. This leader will play an important role in setting the strategic direction for the department, ensuring platform improvements, and driving the integration of emerging technologies. The role serves as a key functional representative, collaborating with Discovery, Manufacturing, and Regulatory to advance programs from preclinical development through successful registration.

Responsibilities

• Leads the purification development and viral safety department to enable development, scale‑up, and technology transfer for both early‑ and late‑stage bioproduct portfolios.
• Establishes and drives the strategic direction of the department, ensuring strong execution to support portfolio growth and meet organizational objectives.
• Provides oversight to ensure the department stays current with emerging technologies, capabilities, and evolving regulatory initiatives, and leads their effective implementation.
• Defines and drives innovation strategy and roadmap to ensure competitiveness and alignment with Discovery and manufacturing needs.
• Proactively reallocates resources to respond to changing portfolio demands, including program acceleration, while driving productivity through operational excellence.
• Leads the adoption and integration of AI/ML tools, process modeling, and high‑throughput screening to advance purification and viral safety workflows.
• Develops talent at all levels and ensures effective coaching and performance management.
• Oversees development laboratory operations, including the scale‑up facility, with a strong focus on workplace safety.
• Collaborates closely with leaders across departments to ensure overall business effectiveness.

Basic Requirements

• Ph.D. in Chemistry, Biochemistry, Chemical Engineering, or related fields, with a minimum of 10 years of pharmaceutical industry experience, or BS/MS with 18+ years of applicable experience.
• Deep knowledge of bioproduct development from candidate selection through regulatory submission.
• Strong track record of technology innovation in downstream bioprocessing or viral safety.
• Excellent communication, interpersonal, and strong leadership skills are essential.
• Demonstrated experience leading high‑performance scientific teams.

Additional Preferences

• Demonstrated experience across end‑to‑end biologics CMC workflows, with broad knowledge of upstream, analytical, and formulation functions and hands‑on regulatory filing experience for early‑ and late‑stage programs.
• Experience collaborating with Manufacturing on GMP implementation, including technology transfer and facility fit.
• Proven ability to collaborate with partners to ensure effective oversight across the entire bioproduct portfolio.
• Experience leveraging AI tools to improve efficiency in CMC workflows.

Additional Information

Physical Demands/Travel

The physical demands of this job are consistent with a laboratory environment.

Travel requirement: less than 10%

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a laboratory environment. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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 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.

Compensation and Benefits

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.

The anticipated wage for this position is

$156,000 - $228,800

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.