Advisor/Senior Advisor, Engineering, Biologics Drug Product Development

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 s to commercialization to support Lilly parenteral product development portfolio.

Requirements

• PhD/MS/BS degree in Pharmaceutical Chemistry or Engineering or related field and the following years of direct industry experience:
• PhD with minimum of 2 years of industry experience in pharmaceutical development or manufacturing
• MS degree with 10 years of industry experience in pharmaceutical development or manufacturing experience
• BS degree with minimum of 12 years of industry experience in pharmaceutical development or manufacturing experience

Extensive knowledge and deep understanding of biologics parenteral product development is required.

Deep understanding of cGMP requirements, ICH and regulatory guidelines are a must.

Additional Preferences

• Proven success track in advancing parenteral products from clinical to BLA/NDA regulatory submission is highly preferred.
• 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 is highly preferred.
• Sound understanding of statistics and data management are essential.
• Strong oral and written communication skills are essential.