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

Eli Lilly and Company • Us, IN

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About The Position

The Lilly Bioproduct Research and Development (BR&D) organization develops and commercializes parenteral formulations of small and large molecules, including monoclonal antibodies, therapeutic proteins, and peptides. The organization also develops genetic medicines and new platforms for complex formulations such as antibody drug conjugates, antibody RNA conjugates, and vaccines.

The Advisor or Senior Advisor, Engineering, Biologics Drug Product Development defines parenteral drug product clinical manufacturing processes and associated control strategies. The role coordinates with internal and external stakeholders—including formulation development, clinical manufacturing, delivery device, analytical development, regulatory affairs, and external contract development and manufacturing organizations—to enable clinical manufacturing, process validation, and regulatory submissions. The position also supports technology transfer, manufacturing oversight, process qualification, regulatory documentation, technical excellence, and evaluation and implementation of technologies from laboratory testing through commercialization.

Requirements

• PhD, MS, or BS degree in Engineering; degrees in Pharmaceutical Sciences or Chemistry may be considered with the specified industry experience.
• For a PhD in Pharmaceutical Sciences or Chemistry: 0–3 years of industry experience in pharmaceutical development or manufacturing.
• For an MS in Pharmaceutical Sciences or Chemistry: 10 or more years of industry experience in pharmaceutical development or manufacturing.
• For a BS in Pharmaceutical Sciences or Chemistry: 12 or more years of industry experience in pharmaceutical development or manufacturing.
• Understanding of cGMP requirements, ICH guidelines, and regulatory guidelines.
• Sound understanding of statistics and data management.
• Strong oral and written communication skills.

Nice To Haves

• Knowledge and understanding of biologics parenteral product development.
• Hands-on experience with laboratory automation and artificial intelligence.
• Experience advancing parenteral products from clinical development through BLA or NDA regulatory submission.
• Demonstrated ability to influence internal and external stakeholders and drive decision-making.
• Sound understanding and hands-on experience developing antibody drug conjugates, antibody RNA conjugates, and other new-modality manufacturing processes.

Responsibilities

• Define and develop clinical manufacturing processes for parenteral drug products.
• Coordinate with cross-functional stakeholders to develop manufacturing process control strategies, process performance criteria, and capability criteria.
• Lead manufacturing process design, including technology evaluation, study design, scale-up models, and mentoring junior scientists in process definition and parameter determination.
• Lead technology transfer, including manufacturing capacity evaluation, gap and risk assessment, mitigation strategy definition, preparation of technology transfer documents, and review of drug product and placebo batch records.
• Collaborate with technology and manufacturing service stakeholders to define process qualification and control strategies.
• Serve as a process technical expert to address critical technical gaps and challenges, and provide onsite manufacturing oversight as needed.
• Author and review regulatory documents supporting IND, BLA, and NDA submissions, and address process-related regulatory inquiries.
• Author and review technical reports.
• Facilitate departmental knowledge sharing and initiatives that promote technical excellence.
• Explore, evaluate, and implement technologies applicable to the drug product development portfolio.
• Monitor process technology and drive evaluation and implementation of new technologies from bench testing through commercialization.
• Comply with corporate, divisional, and departmental procedures, including good manufacturing practices, safety requirements, and applicable regulations.
• Participate in establishing and maintaining departmental quality systems.
• Build effective networks with internal and external stakeholders to promote collaboration and accelerate cross-functional decision-making.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior