Advisor​/Senior Advisor, Engineering, Biologics Drug Product Development

Position Summary

The Lilly Bioproduct Research and Development (BR&D) organization focuses on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. The organization is also committed to genetic medicines including oligonucleotide development, nanomedicines for tissue‑specific targeting, and other gene delivery strategies. The drug product team builds platforms to support complex formulations such as lipid nanoparticles (LNPs), antibody drug conjugates, AAV, and other non‑viral vector delivery vehicles.

We are seeking a highly motivated candidate for the position of Advisor or Senior Advisor, Engineering, Biologics Drug Product Development. This position is accountable for defining parenteral drug product clinical manufacturing processes and associated control strategies, and for driving coordination and collaboration within and across stakeholders including formulation development, clinical manufacturing, delivery device, analytical development, RA, and external CDMO to enable clinical manufacturing and process validation and support regulatory submission.

• Define and develop clinical manufacturing processes for parenteral drug products to support clinical manufacturing.
• Drive collaboration with cross‑functional stakeholders to develop manufacturing process control strategies, process performance criteria, and capability criteria.
• Lead manufacturing‑related process design including tech evaluation, study design, scale‑up model and mentoring junior scientists to define manufacturing process and determine process parameters.
• Serve as tech lead to drive tech transfer, including internal and external manufacturing capacity evaluation, gap/risk assessment, mitigation strategy, authoring tech transfer documents, and reviewing batch records for drug product and placebo.
• Collaborate with tech/manufacturing service stakeholders to define process qualification and control strategy and serve as process tech expert to address critical technical gaps and/or challenges, providing onsite oversight of manufacturing as needed.
• Author and review regulatory documents to support regulatory submission of IND, BLA and NDA and address any process‑related regulatory inquiries.
• Author and review technical reports.
• Play a critical role in facilitating departmental knowledge sharing and initiatives to promote technical excellence.
• Serve as tech expert to explore, evaluate and implement new technologies applicable to drug product development from clinical to commercialization.
• Stay abreast of current process technology to drive evaluation and implementation of new technology from bench test to commercialization for Lilly parenteral product development portfolio.
• Understand and comply with corporate, divisional, and departmental procedures, including G‑MP, safety, and other applicable regulations, and participate in the establishment and maintenance of departmental quality systems.
• Establish effective networks with internal and external stakeholders to promote effective collaboration to accelerate cross‑functional decision‑making.

• PhD with minimum of 2 years of industry experience in pharmaceutical development or manufacturing.
• MS degree with minimum of 10 years of industry experience in pharmaceutical development or manufacturing.
• BS degree with minimum of 12 years of industry experience in pharmaceutical development or manufacturing.
• Extensive knowledge and deep understanding of biologics parenteral product development.
• Deep understanding of cGMP requirements, ICH and regulatory guidelines.

• Proven success track in advancing parenteral products from clinical to BLA/NDA regulatory submission.
• Demonstrated ability to influence internal and external stakeholders to drive decision‑making.
• Sound understanding and hands‑on experience in developing ADC, mRNA LNP and other new‑modality manufacturing processes.
• Sound understanding of statistics and data management.
• Strong oral and written communication skills.

The physical demands of this job are…