Drug Product Development Engineer

4 days ago


Marquand, Missouri, United States Eli Lilly Full time
Job Summary:
Eli Lilly is seeking a highly motivated and experienced Drug Product Development Engineer to join our team in Indianapolis, IN. This role will be responsible for developing and commercializing parenteral drug products through various stages of clinical development. The ideal candidate will have a strong background in parenteral manufacturing processes and stability issues associated with parenteral drug products.

About the Role:
This position will involve leading process development of bioproduct dosage form development projects and participating in the bioproduct formulation development. The successful candidate will define and develop manufacturing processes, including process performance and capability criteria, for bioproduct dosage forms intended for the commercial market. They will also develop processes for use in clinical trial manufacturing, develop manufacturing process control strategies for clinical and commercial products, and lead the preparation of the CMC portion of the IND/CTA/BLA/NDA.

Responsibilities:
  • Develops manufacturing processes for bioproduct dosage forms intended for the commercial market.
  • Develops processes for use in clinical trial manufacturing.
  • Develops manufacturing process control strategies for clinical and commercial products.
  • Leads the preparation of the CMC portion of the IND/CTA/BLA/NDA.
  • Collaborates with cross-functional teams to ensure seamless execution of projects.

Requirements:
  • Bachelor's or master's degree in engineering or a related field.
  • 0-5 years of experience in parenteral manufacturing processes.
  • Advanced computer skills, including computational modeling, database creation, analysis tool creation, and statistics.
  • Excellent oral and written communication skills.

Estimated Salary:$120,000 - $160,000 per year

The estimated salary range is based on national averages and may vary depending on location, experience, and other factors.

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