Advisor/Sr Advisor/Director – Manufacturing Science

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.

Company Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Brand Description

How would you like a career where you get to apply your best technical and analytical skills to bring complex, high-potency biologic medicines to patients? We are seeking a scientific leader on our Parenteral Product Network Technical Services/Manufacturing Science (TS/MS) team to drive the commercialization of lyophilized drug products, with a focus on antibody drug conjugates (ADCs), and to provide technical support for commercial lyophilized product manufacturing.

In this role, you are critical to the success of Lilly’s oncology and biologics portfolio. As a Global Product Steward and lyophilization process expert, you will hold technical ownership of assigned lyophilized ADC and other parenteral products from late-stage development through the commercial lifecycle, serving as the technical link between Product Development and our commercial manufacturing sites. You will ensure these products are successfully launched, reliably supplied, and technically well controlled across internal and external sites.

Responsibilities

As an individual contributor, you will work side by side with colleagues in Product Development, Manufacturing Operations, Quality, EHS, and Supply Chain, as well as with external manufacturing organizations. You will be a visible technical presence in cross-functional teams, mentor junior technical associates, and escalate significant technical, quality, safety, and supply risks to management with clear assessments and recommended actions.

Key responsibilities include:

• Serve as Global Product Steward and subject matter expert for lyophilized, ADC and parenteral products, holding end-to-end technical accountability for process performance, product quality, and supply across all manufacturing sites, and serving as the primary technical interface between Product Development and commercial manufacturing.

• Advance lyophilization technology in commercial manufacturing

• Maintain the product technical knowledge base and lifecycle strategy, including process history, critical material and supplier knowledge, a product technical risk register, and a roadmap for yield, robustness, capacity, and site-network improvements.

• Collaborate with product development and manufacturing site for technology transfer, scale-up, process performance qualification/validation, and comparability activities (including lyophilization cycle transfer between freeze-dryers of differing scale and design) to support commercial launch readiness.

• Escalate significant technical, quality, safety, compliance, and supply risks to TS/MS management in a timely manner, providing risk assessments, impact to patients and supply, and recommended mitigation plans.

• Own the commercial control strategy for lyophilization critical process parameters and critical quality attributes, and 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 to provide commercial manufacturing feedback that informs 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, and support inspection readiness at commercial sites.

• Lead process improvement and lifecycle management projects, including introduction of new lyophilization, filling, and containment technologies and qualification of vials, stoppers, and other critical materials.

Basic Qualifications

• A degree in a relevant area such as Pharmaceutical Science, Chemical Engineering, Biochemistry, or Chemistry with one of the following:

  • PhD degree with 5 years of practical experience in parenteral, biologic, or antibody drug conjugate drug substance or drug product development and/or manufacturing, or
  • Master’s degree with 10 years of practical experience in parenteral, biologic, or antibody drug conjugate drug substance or drug product development and/or manufacturing, or
  • Bachelor’s degree with 15 years of practical experience in parenteral, biologic, or antibody drug conjugate drug substance or drug product development and/or manufacturing.

• Hands-on experience with lyophilization development or manufacturing (e.g., formulation and cycle development, scale-up, tech 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.

Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Skills/Preferences

We want you to bring your lyophilization and biologics expertise, commercial manufacturing experience, and technical influence to help launch and supply ADC and other lyophilized medicines.

Preferred experience includes:

• Direct ADC drug product experience, including handling of cytotoxic or highly potent payloads and the stability and process sensitivities of conjugated antibodies.

• Background in lyophilized product development, including formulation and excipient selection, freeze-drying cycle design, and thermal characterization, and cycle scale-up.

• Analytical characterization of lyophilized biologics and ADCs

• Experience with container closure and critical material qualification, including vial and stopper selection, container closure integrity, and the interaction of materials 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 the ability to interpret complex technical data, troubleshoot manufacturing issues, and clearly escalate risks and recommendations to management.

• Preparation, review, and response to global regulatory submissions (e.g., BLAs, NDAs, or equivalent), post-approval changes, and support of regulatory inspections.

• Working knowledge of statistical design of experiments and analysis, and of containment strategies and occupational exposure limits for potent compounds.

• Strong written and oral communication skills, with the ability to collaborate effectively across Development, Operations, Quality, EHS, and external manufacturing partners.

We’re also excited if you bring an insatiable desire to learn, to innovate, and to challenge yourself for the benefit of patients.

Additional Information

• Recognition and future promotion on the Technical Ladder

• 10–20% domestic and international travel to commercial manufacturing sites and partners (to be confirmed by leadership)

• Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

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 $130,500 - $211,200

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.

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