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

Position Summary

The Lilly Bioproduct Research and Development (BR&D) organization is focused 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 the development of genetic medicines which includes active investments in oligonucleotide development, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in building new platforms to support complex formulations such as antibody drug conjugates (ADC), antibody RNA conjugates (ARC), and vaccines.

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 along with the associated control strategies. Additionally, this individual will drive coordination and collaboration within and cross-functional stakeholders including but not limited to formulation development, clinical manufacturing, delivery device, analytical development, RA and external CDMO, etc. to enable clinical manufacturing and process validation as well as support regulatory submission.

Responsibilities

• 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 but not limited to internal and external manufacturing capacity evaluation, gap/risk assessment, defining mitigation strategy, authoring tech transfer documents, as well as reviewing batch records for drug product and placebo.
• Collaborate with tech/manufacturing service stakeholders to define process qualification and control strategy as well as serve as process tech expert to address critical technical gaps and/or challenges, provide onsite oversight of manufacturing as needed.
• Author and review regulatory documents to support regulatory submission of IND, BLA and NDA as well as 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 portfolio from clinical to commercialization.
• Stay abreast of current process technology to drive evaluation and implementation of new technology from bench test to commercialization to support Lilly parenteral product development portfolio.
• Understand and comply with corporate, divisional, and departmental procedures, including good manufacturing practices, 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.

Basic Requirements

• PhD, MS, or BS degree in Engineering; will consider degree in Pharmaceutical Sciences/Chemistry
• PhD with 0-3 years of industry experience in pharmaceutical development or manufacturing experience
• MS degree with 10+ years of industry experience in pharmaceutical development or manufacturing experience
• BS degree with 12+ years of industry experience in pharmaceutical development or manufacturing experience

Additional Preferences

• Knowledge and understanding of biologics parenteral product development
• Understanding cGMP requirements, ICH and regulatory guidelines
• Knowledge of and hands-on experience with lab automation and artificial intelligence (AI) is a plus
• Experience in advancing parenteral products from clinical to BLA/NDA regulatory submission is preferred
• Demonstrated ability to influence internal and external stakeholders to drive decision-making
• Sound understanding and hands-on experience in developing antibody drug conjugates (ADC), antibody RNA conjugates (ARC), and other new modality manufacturing processes is preferred
• Sound understanding of statistics and data management are essential
• Strong oral and written communication skills are essential