Associate Director- Technical Services/Manufacturing Science Lead

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

401(k) plan

Health insurance

Paid time off

Job summary

Eli Lilly and Company is seeking a senior professional to lead deviations investigations, root-cause analysis, and CAPA implementation in drug substance and product manufacturing. You will provide scientific leadership for process monitoring, troubleshooting, and optimization, and collaborate across R&D, Quality, and Regulatory teams.

The role emphasizes technology transfer, process validation strategies, and continued process verification, with mentoring responsibilities within the TS/MS group.

Qualifications

• Bachelor's degree in a related scientific discipline.
• 7+ years in pharma/biotech manufacturing science, process development or technical services.

Responsibilities

• Lead deviations investigations, identify root causes, implement CAPAs.
• Provide scientific/technical leadership for drug substance/product manufacturing, including monitoring, troubleshooting, and optimization.
• Drive CI initiatives to improve process performance, yield, cost, and compliance; define control strategy.
• Support technology transfer for new products/processes/sites; ensure successful implementation.
• Develop and execute process validation strategies, CPV development.
• Prepare technical reports, protocols, and regulatory submission documents (CMC).
• Collaborate with R&D, Quality, Manufacturing, Engineering, and Regulatory.
• Lead or support audits/inspections with technical expertise.
• Mentor junior scientists/engineers within TS/MS team.
• Stay current on industry trends and regulatory requirements in manufacturing science.
• Experience in Radioligand Therapies preferred.

Skills

Problem solving

Communication

Leadership

Cross-functional collaboration

Regulatory awareness

Education

Bachelor's degree in Chemical Engineering / Biotechnology / Biochemistry / Pharmaceutical Sciences

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.

Job Responsibilities

• Lead investigations into deviations and non-conformances, determining root causes and implementing CAPAs.
• Provide scientific and technical leadership for drug substance/product manufacturing, including process monitoring, troubleshooting, and optimization.
• Drive continuous improvement initiatives to enhance process performance, yield, cost, and compliance, and define/sustain the control strategy for a robust, reliable process.
• Support technology transfer for new products, processes, or sites, ensuring successful implementation.
• Develop and execute process validation strategies, including continued process verification (CPV).
• Author and review technical reports, protocols, and regulatory submission documents (e.g., CMC sections).
• Collaborate cross-functionally with R&D, Quality, Manufacturing, Engineering, and Regulatory Affairs.
• Lead the sterility assurance team and its responsibilities.
• Mentor junior scientists and engineers within the TS/MS team.
• Lead or support internal/external audits and inspections with technical expertise.
• Stay current on industry trends, technologies, and regulatory requirements in manufacturing science.

Job Qualifications

• Bachelor's degree in Chemical Engineering, Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 7+ years of experience in the pharmaceutical or biotechnology industry, with a strong focus on manufacturing science, process development, or technical services.
• Additional Preferences Strong understanding of cGMP regulations, ICH guidelines, and related regulatory requirements.
• Experience with technology transfer and process validation.
• Proven track record leading complex technical projects and solving challenging manufacturing issues.
• Strong problem-solving and critical thinking skills.
• Excellent written and verbal communication, with ability to explain complex technical information to diverse audiences.
• Collaborative, team-oriented approach to cross-functional work.
• Experience in Radioligand Therapies highly preferred.

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).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $123,000 - $180,400 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.

#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!