Sr. Director - Biologics Purification

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 156,000 - 229,000; Full time

Benefits offered by this job

401(k)

Pension

Health insurance

Flexible benefits

Life insurance

Job summary

Lilly in Indianapolis seeks a Senior Director to lead the purification CMC function for biologics. You will oversee downstream process development, scale‑up, viral clearance strategy, technology transfer, and regulatory submissions for monoclonal antibodies and related bioproducts.

You will shape the departmental strategy, integrate emerging technologies, and collaborate with Discovery, Manufacturing, and Regulatory to advance programs from preclinical to registration.

Qualifications

• PhD or MS with extensive pharma CMC experience.
• Deep knowledge of bioproduct development from candidate selection through regulatory submission.
• Strong track record leading high‑performance scientific teams.

Responsibilities

• Leads purification development including viral safety to enable development, scale‑up and tech transfer.
• Establishes strategic direction and ensures execution to support portfolio growth.
• Maintains current with emerging tech and regulatory initiatives; implements effectively.
• Defines innovation strategy and roadmap aligned with Discovery and manufacturing needs.
• Oversees resource allocation to meet portfolio demands and drive productivity.
• Leads adoption of AI/ML tools, process modeling, and high‑throughput screening.
• Develops talent and manages performance across the organization.
• Oversees development lab ops and scale‑up facilities with safety focus.
• Collaborates with leaders across departments to ensure business effectiveness.

Skills

Bioproduct development knowledge

Regulatory submissions

Leadership of 10+ staff

AI/ML in bioprocessing

Strategic planning

Education

PhD in Chemistry, Biochemistry, Chemical Engineering or related

MS with 18+ years of applicable pharma experience

Tools

AI/ML tools

Technology transfer

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.

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 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, 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 department including viral safety 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 M.S. 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 other biologics CMC areas (i.e., upstream or analytical).
• Excellent communication, interpersonal, and strong leadership skills are essential.
• Demonstrated experience leading high-performance scientific teams comprising 10+ employees.

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 is highly preferred.

Additional Information:

Physical Demands/Travel:

The physical demands of this job are consistent with a lab 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 that must be met by an employee to successfully perform 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 (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 $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.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly