Director – Manufacturing Science

Lilly•Indianapolis, IN

2d•$130,500 - $211,200

About The Position

Lilly is seeking a scientific leader for its Parenteral Product Network Technical Services/Manufacturing Science team to drive commercialization of lyophilized drug products, especially antibody drug conjugates (ADCs), and provide technical support for commercial lyophilized product manufacturing. The role supports Lilly’s oncology and biologics portfolio and serves as a Global Product Steward and lyophilization process expert, with technical ownership of assigned lyophilized ADC and other parenteral products from late-stage development through the commercial lifecycle. The position connects Product Development with commercial manufacturing sites and helps ensure successful launches, reliable supply, and technical control across internal and external sites. As an individual contributor, the role works closely with Product Development, Manufacturing Operations, Quality, EHS, Supply Chain, and external manufacturing organizations. It serves as a visible technical presence on cross-functional teams, mentors junior technical associates, and communicates significant technical, quality, safety, compliance, and supply risks to management with assessments and recommended actions. The position is eligible for recognition and future promotion on the Technical Ladder. Domestic and international travel to manufacturing sites and partners is estimated at 10–20%, to be confirmed by leadership. The anticipated wage is $130,500–$211,200, depending on education, experience, skills, and geographic location. Full-time equivalent employees are eligible for a company bonus, depending in part on company and individual performance, and eligible employees may participate in a comprehensive benefits program.

Requirements

A degree in a relevant area such as Pharmaceutical Science, Chemical Engineering, Biochemistry, or Chemistry.
Practical experience in parenteral, biologic, or antibody drug conjugate drug substance or drug product development and/or manufacturing, meeting one of the following: PhD and 5 years; master’s degree and 10 years; or bachelor’s degree and 15 years.
Hands-on experience with lyophilization development or manufacturing, such as formulation and cycle development, scale-up, technology transfer, or commercial cycle support.
Working knowledge of protein-based and ADC drug product formulation and aseptic fill/finish processes.
Experience supporting GMP commercial manufacturing, including technology transfer, process validation, and/or deviation investigation and resolution.
Legal authorization to work in the United States. Lilly does not anticipate providing employment visa sponsorship, such as H-1B or TN status.

Nice To Haves

Direct ADC drug product experience, including handling cytotoxic or highly potent payloads and understanding the stability and process sensitivities of conjugated antibodies.
Background in lyophilized product development, including formulation and excipient selection, freeze-drying cycle design, thermal characterization, and cycle scale-up.
Analytical characterization experience with lyophilized biologics and ADCs.
Experience with container closure and critical material qualification, including vial and stopper selection, container closure integrity, and material interactions with processing equipment.
Product stewardship experience, such as serving as technical owner or product lead for a commercial or late-stage product, authoring annual product reviews or technical risk assessments, and managing multi-site process harmonization.
Demonstrated leadership, influence, and problem-solving skills, including interpreting complex technical data, troubleshooting manufacturing issues, and clearly escalating risks and recommendations to management.
Experience preparing, reviewing, and responding to global regulatory submissions such as BLAs, NDAs, or equivalents, post-approval changes, and supporting regulatory inspections.
Working knowledge of statistical design of experiments and analysis, containment strategies, and occupational exposure limits for potent compounds.
Strong written and oral communication skills and ability to collaborate across Development, Operations, Quality, EHS, and external manufacturing partners.
Desire to learn, innovate, and challenge oneself for the benefit of patients.

Responsibilities

Serve as Global Product Steward and subject matter expert for lyophilized, ADC, and parenteral products, with end-to-end technical accountability for process performance, product quality, and supply across manufacturing sites.
Serve as the primary technical interface between Product Development and commercial manufacturing.
Advance lyophilization technology in commercial manufacturing.
Maintain product technical knowledge and lifecycle strategy, including process history, critical material and supplier knowledge, a technical risk register, and a roadmap for yield, robustness, capacity, and site-network improvements.
Collaborate with Product Development and manufacturing sites on technology transfer, scale-up, process performance qualification and validation, and comparability activities, including lyophilization cycle transfer between freeze-dryers of differing scale and design.
Escalate significant technical, quality, safety, compliance, and supply risks to TS/MS management with timely risk assessments, patient and supply impact assessments, and recommended mitigation plans.
Own the commercial control strategy for lyophilization critical process parameters and critical quality attributes.
Maintain process understanding through continued process verification, stability and batch trending, and global product assessment.
Partner with Product Development to ensure manufacturability of new ADC and lyophilized products and provide commercial manufacturing feedback on formulation, cycle design, specifications, container closure selection, and site selection.
Author and review technical sections of global regulatory submissions, post-approval changes, and responses to regulatory questions; support inspection readiness at commercial sites.
Lead process improvement and lifecycle management projects, including introducing lyophilization, filling, and containment technologies and qualifying vials, stoppers, and other critical materials.
Work with cross-functional colleagues and external manufacturing organizations as a technical contributor.
Mentor junior technical associates.
Bring significant technical, quality, safety, and supply risks to management’s attention with clear assessments and recommended actions.

Benefits

Company bonus for full-time equivalent employees, depending in part on company and individual performance.
Company-sponsored 401(k) participation eligibility.
Pension.
Vacation benefits.
Medical benefits eligibility.
Dental benefits eligibility.
Vision benefits eligibility.
Prescription drug benefits eligibility.
Flexible benefits, including 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, including an employee assistance program, fitness benefits, and employee clubs and activities.