Principal Process Engineer, Parenteral Drug Product Development

Role Summary

Principal Process Engineer, Biologics Drug Product Development, based at Lilly Technology Center in Indianapolis. Lead development of parenteral drug product clinical manufacturing processes and associated control strategies for biologics, including monoclonal antibodies, novel therapeutic proteins and peptides, and complex formulations and platforms such as lipid nanoparticles, antibody-drug conjugates, AAV, and other delivery modalities. Collaborate across formulation development, clinical manufacturing, delivery devices, analytical development, regulatory affairs, and external CDMO partners to support clinical manufacturing, process validation, tech transfer, and regulatory submissions.

Author and co-author process development technical documents and contribute to regulatory submissions and technical reports.

• Develop parenteral drug product clinical manufacturing processes along with the associated control strategies.
• Collaborate with cross-functional team members including but not limited to formulation development, clinical manufacturing, delivery devices, analytical development, RA and external CDMO, etc. to support clinical manufacturing and process validation to enable regulatory submission.
• Design and execute manufacturing related process studies to determine process parameters and define processes to enable clinical manufacturing
• Lead and/or assist tech transfer activities including but not limited to evaluating contact material compatibility, internal and CDMO capacity, authoring tech transfer documents, as well as reviewing batch records for drug products and placebos.
• Author or coauthor and maintain process development technical documents.
• Collaborate with cross functional team to help develop manufacturing process control strategies, process performance criteria, and capability criteria.
• Collaborate with tech/mfg service team to support process qualification including defining process qualification and control strategy as well as providing onsite oversight of manufacturing.
• Co-author or author drug product process development tech reports and regulatory submissions of IND, BLA or NDA as well as provide tech support in addressing any regulatory inquires.
• Support and take part in evaluation and implementation of departmental initiatives to promote technical excellence.
• Support evaluation and implementation of available new technologies applicable to drug product development portfolio from clinical to commercialization.
• 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.
• Maintain an awareness of the proper use and maintenance of processing and laboratory equipment in the development facility. Properly address safety and environmental issues.

• Required:
  
  B.S. in Pharmaceutical Chemistry or Engineering with related industry experience; B.S. with at least 5 years of experience or M.S. with at least 3 years of experience.
• Required:
  
  Working knowledge and understanding of parenteral product development.
• Required:
  
  Authorized to work in the United States on a full-time basis; sponsorship for work authorization or visas is not provided.
• Preferred:
  Good understanding of cGMP requirements and ICH guidelines.
• Preferred:
  Good understanding of stability and potential degradation pathways of protein and peptides.
• Preferred:
  Working knowledge and experience in handling and developing ADC and mRNA LNP manufacturing processes.
• Preferred:
  Sound understanding of statistics and data management.
• Preferred:
  Effective oral and written communication skills.

• cGMP and ICH guidelines understanding
• Stability and degradation pathways knowledge for proteins/peptides
• ADC and mRNA LNP manufacturing process experience
• Statistics and data management
• Effective oral and written communication skills

• B.S. or M.S. in Pharmaceutical Chemistry or Engineering (with related industry experience).

• Physical Demands/Travel:
  The physical demands of this job are consistent with a lab environment.