Senior Advisor, Biologics Drug Product Development

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 129,000 - 209,000; Full time

Job summary

Lilly is seeking a highly motivated Advisor/Senior Advisor, Engineering, Biologics Drug Product Development in Indianapolis to define parenteral manufacturing processes and drive cross-functional collaboration from clinical development through regulatory submission.

The role requires advanced degrees in engineering with extensive biologics experience, knowledge of cGMP and ICH guidelines, and strong technical leadership across tech transfer, process development, and regulatory documentation.

Qualifications

• PhD with 2+ 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.
• Extensive knowledge and deep understanding of biologics parenteral product development is required.
• Deep understanding of cGMP requirements, ICH and regulatory guidelines are a must.

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.

Skills

Biologics parenteral development

Regulatory knowledge

Cross-functional leadership

Mentoring/leadership

Tech transfer

Education

PhD in Engineering

MS in Engineering

BS in Engineering

Tools

Regulatory submission experience

Job description

Lilly is seeking a highly motivated Advisor/Senior Advisor, Engineering, Biologics Drug Product Development in Indianapolis to define parenteral manufacturing processes and drive cross-functional collaboration from clinical development through regulatory submission.

The role requires advanced degrees in engineering with extensive biologics experience, knowledge of cGMP and ICH guidelines, and strong technical leadership across tech transfer, process development, and regulatory documentation.