Principal Engineer, Formulation Development
Location: Indianapolis, Indiana, United States
Category: Research & Development
Job Type: Full Time, Regular
Job ID: R-74451
Overview:
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana, with employees dedicated to discovering and delivering life-changing medicines, improving disease management, and supporting communities through philanthropy and volunteerism.
Position Summary:
Lilly Bioproduct Research and Development (BR&D) is focused on developing and commercializing parenteral formulations of small and large molecules, including monoclonal antibodies, novel therapeutic proteins, peptides, and genetic medicines. The team is also investing in new platforms for complex formulations such as lipid nanoparticles, Antibody Drug Conjugates, and AAV and non-viral vector delivery.
We are seeking highly motivated professionals experienced in developing and commercializing parenteral drug products through various clinical stages.
Responsibilities:
Lead process development for bioproduct dosage form development projects and support formulation development as needed.
Define and develop manufacturing processes, including process performance and capability criteria, for commercial bioproduct dosage forms.
Develop processes for clinical trial manufacturing and establish manufacturing process control strategies.
Lead preparation of CMC sections for IND/CTA/BLA/NDA submissions.
Support Clinical Trial Operations in preparing manufacturing records and producing clinical supply lots.
Manufacture and evaluate clinical trial formulations and processes for commercial viability.
Ensure data generation supports process parameters and characterizes materials for process performance.
Utilize advanced mathematical methods and computational tools to support process modeling and equipment development.
Assist in developing an integrated database for data mining and predicting formulation performance at larger scales.
Properly document development work and maintain laboratory records.
Collaborate with TS/MS, ETC, and Indy parenteral teams to define manufacturing processes, scale-up experiments, and validation strategies.
Author or co-author technical reports and transfer technology to production operations.
Assist production technical services in supporting marketed products.
Promote technical excellence through coordination, evaluation, and review of departmental initiatives.
Develop and communicate project plans, goals, and timelines effectively.
Stay current with industry trends and identify opportunities for improved processing technologies.
Ensure compliance with corporate, divisional, and departmental procedures, including GMP, safety, and applicable regulations.
Develop expertise in unit operations for bioproduct manufacturing and create unit operation-specific data analysis tools.
Establish effective networks with engineers within and external to Lilly to leverage capabilities for the department.
Basic Requirements:
Master’s degree in engineering or related field with 2+ years of industry experience, or bachelor’s degree in engineering or related field with 5+ years of industry experience.
Additional Preferences:
Creativity and the ability to transform ideas into practical processes and products.
Background in parenteral manufacturing processes and stability issues associated with parenteral drug products (e.g., proteins, peptides, or genomic medicines).
Strong mechanical aptitude and advanced computer skills (e.g., computational modeling, database creation, analysis tool creation, and statistics).
Excellent oral and written communication skills.
Physical Demands/Work Environment:
Consistent with a laboratory environment.
May involve physical demands representative of essential job functions.
Additional Information:
Lilly is dedicated to helping individuals with disabilities engage actively in the workforce and ensures equal opportunities for all candidates. If accommodation is required, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation).
EEO Statement:
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
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