Advisor/Sr. Advisor, Engineering - Biologics Drug Product Development

Eli Lilly and Company; Indianapolis (IN); On-site; USD 131,000 - 211,000; Full time

Job summary

Lilly in Indianapolis is seeking an Advisor or Senior Advisor, Engineering, Biologics Drug Product Development to define parenteral manufacturing processes for clinical and early commercial use, lead cross-functional tech transfer, and ensure regulatory readiness from IND to NDA.

The role requires deep knowledge of biologics, cGMP, and emerging technologies; you will mentor scientists, drive process qualification, and stay abreast of new platforms while collaborating with RA, analytical, and

Qualifications

• Knowledge and understanding of biologics parenteral product development.
• Understanding cGMP requirements, ICH and regulatory guidelines.
• Knowledge of and hands-on experience with lab automation and AI is a plus.
• Experience in advancing parenteral products from clinical to BLA/NDA regulatory submission is preferred.
• Demonstrated ability to influence internal and external stakeholders to drive decision-making.
• Sound understanding of antibody drug conjugates (ADC), antibody RNA conjugates (ARC), and other new modality manufacturing processes is preferred.
• Sound understanding of statistics and data management are essential.
• Strong oral and written communication skills are essential.

Responsibilities

• Define clinical manufacturing processes for parenteral drug products to support clinical manufacturing.
• Drive collaboration with cross-functional stakeholders to develop manufacturing process control strategies and criteria.
• Lead manufacturing related process design including study design, scale-up, and mentoring junior scientists.
• Serve as tech lead to drive tech transfer and review batch records for drug product and placebo.
• Collaborate with stakeholders to define process qualification and control strategies and address technical gaps.
• Author and review regulatory documents to support IND, BLA and NDA submissions.
• Author and review technical reports and promote knowledge sharing.
• Stay abreast of new technologies to drive evaluation and implementation across the portfolio.
• Ensure compliance with GMP and other regulations and maintain quality systems.

Skills

Biologics parenteral development

cGMP knowledge

Lab automation

AI experience

ADC/ARC knowledge

Statistics

Data management

Oral and written communication

Education

PhD with 0-3 years of experience

MS with 10+ years of experience

BS with 12+ years of experience

Job description

About Lilly

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.

Position Summary

The Lilly Bioproduct Research and Development (BR&D) organization is focused on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. The organization is also committed to the development of genetic medicines which includes active investments in oligonucleotide development, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in building new platforms to support complex formulations such as antibody drug conjugates (ADC), antibody RNA conjugates (ARC), and vaccines. We are seeking a highly motivated candidate for the position of Advisor or Senior Advisor, Engineering, Biologics Drug Product Development. This position is accountable for defining parenteral drug product clinical manufacturing processes along with the associated control strategies. Additionally, this individual will drive coordination and collaboration within and cross‑functional stakeholders including but not limited to formulation development, clinical manufacturing, delivery device, analytical development, RA and external CDMO, etc. to enable clinical manufacturing and process validation as well as support regulatory submission.

Responsibilities

• Define and develop clinical manufacturing processes for parenteral drug products to support clinical manufacturing.
• Drive collaboration with cross functional stakeholders to develop manufacturing process control strategies, process performance criteria, and capability criteria.
• Lead manufacturing related process design including tech evaluation, study design, scale‑up model and mentoring junior scientists to define manufacturing process and determine process parameters.
• Serve as tech lead to drive tech transfer including but not limited to internal and external manufacturing capacity evaluation, gap/risk assessment, defining mitigation strategy, authoring tech transfer documents, as well as reviewing batch records for drug product and placebo.
• Collaborate with tech/manufacturing service stakeholders to define process qualification and control strategy as well as serve as process tech expert to address critical technical gaps and/or challenges, provide onsite oversight of manufacturing as needed.
• Author and review regulatory documents to support regulatory submission of IND, BLA and NDA as well as address any process related regulatory inquiries.
• Author and review technical reports.
• Play a critical role in facilitating departmental knowledge sharing and initiatives to promote technical excellence.
• Serve as tech expert to explore, evaluate and implement new technologies applicable to drug product development portfolio from clinical to commercialization.
• Stay abreast of current process technology to drive evaluation and implementation of new technology from bench test to commercialization to support Lilly parenteral product development portfolio.
• Understand and comply with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and participate in the establishment and maintenance of departmental Quality systems.
• Establish effective networks with internal and external stakeholders to promote effective collaboration to accelerate cross‑functional decision‑making.

Basic Requirements

• PhD, MS, or BS degree in Engineering; will consider degree in Pharmaceutical Sciences/Chemistry and the following corresponding years of industry experience: PhD with 0-3 years of industry experience in pharmaceutical development or manufacturing experience.
• MS degree with 10+ years of industry experience in pharmaceutical development or manufacturing experience.
• BS degree with 12+ years of industry experience in pharmaceutical development or manufacturing experience.

Additional Preferences

• Knowledge and understanding of biologics parenteral product development.
• Understanding cGMP requirements, ICH and regulatory guidelines.
• Knowledge of and hands‑on experience with lab automation and artificial intelligence (AI) is a plus.
• Experience in advancing parenteral products from clinical to BLA/NDA regulatory submission is preferred.
• Demonstrated ability to influence internal and external stakeholders to drive decision‑making.
• Sound understanding and hands‑on experience in developing antibody drug conjugates (ADC), antibody RNA conjugates (ARC), and other new modality manufacturing processes is preferred.
• Sound understanding of statistics and data management are essential.
• Strong oral and written communication skills are essential.

Additional Information

Physical Demands/Travel: The physical demands of this job are consistent with a lab environment. 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. 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).

Benefits

• company-sponsored 401(k);
• pension;
• vacation benefits;
• 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).

The anticipated wage for this position is $130,500 - $211,200. Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). 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