Associate Director- RLT Technical Services/Manufacturing Science Lead

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.

Additional information

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