Job Title: Principal Engineer, Formulation Development
Location: Indianapolis, Indiana, United States of America
Category: Research & Development
Job Type: Full-Time, Regular
Job Id: R-74451
Company Overview:
At Lilly, we are committed to making life better for people around the world. As a global healthcare leader, we are driven by discovery and focused on bringing life-changing medicines to those who need them. We take pride in our community involvement and our work to enhance the understanding and management of disease. Our team is dedicated to improving lives and advancing healthcare through innovation, passion, and compassion.
Position Overview:
Lilly’s Bioproduct Research and Development (BR&D) organization is at the forefront of developing and commercializing parenteral formulations for both small molecules and large molecules, including monoclonal antibodies, therapeutic proteins, peptides, and genetic medicines. We are also advancing new platforms such as lipid nanoparticles, antibody-drug conjugates, and AAV gene delivery systems.
We are seeking a Principal Engineer in Formulation Development to join our team and take an active role in the development of innovative drug formulations and delivery systems. This is a critical role where the ideal candidate will contribute to the development and commercialization of parenteral drug products through various stages of clinical development.
Key Responsibilities:
Process Development: Lead process development for bioproduct dosage forms and participate in formulation development as necessary. Define and develop manufacturing processes for both clinical and commercial bioproducts, ensuring process performance, scalability, and capability.
Clinical & Commercial Manufacturing: Develop processes for clinical trial manufacturing and prepare the CMC (Chemistry, Manufacturing, and Controls) sections for IND/CTA/BLA/NDA submissions. Oversee scale-up experiments and ensure that the formulations and processes meet commercial viability.
Process Control & Data Analysis: Develop and implement manufacturing process control strategies. Utilize advanced mathematical methods and computational tools to model and analyze processes, ensuring scalability and performance at larger scales.
Collaboration & Technology Transfer: Collaborate with cross-functional teams (e.g., TS/MS, QA, Operations) to define manufacturing processes, and transfer technology from the lab to production operations. Ensure smooth technology transfer and provide technical support for marketed products.
Innovation & Process Improvement: Stay abreast of new technologies in the field, implement new processing methods, and improve current formulation and drug delivery systems. Evaluate and implement innovative technologies from the bench scale to commercialization.
Mentorship: Provide guidance to junior engineers and participate in the development of a strong, technical team culture. Develop and maintain effective networks with external and internal teams to leverage capabilities.
Regulatory & Quality Compliance: Ensure compliance with corporate, divisional, and departmental procedures, including Good Manufacturing Practices (GMP), safety regulations, and quality standards. Lead the establishment and maintenance of departmental quality systems.
Documentation & Reporting: Properly document development work, maintaining detailed laboratory notebooks and technical reports. Create and maintain development equipment flow charts and other essential documentation.
Basic Qualifications:
Master’s Degree in Engineering or a related field with 2+ years of industry experience, or Bachelor’s Degree in Engineering or a related field with 5+ years of industry experience.
Proven experience in bioproduct formulation and manufacturing processes with an emphasis on parenteral drug products (e.g., proteins, peptides, or genomic medicines).
Preferred Qualifications:
Physical Demands/Work Environment:
The physical demands of this job are consistent with a laboratory environment. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Additional Information:
Lilly is dedicated to helping individuals with disabilities engage in the workforce by ensuring equal opportunities during the application process. If you need accommodations to submit a resume, please complete the accommodation request form for assistance.
Equal Opportunity Employer:
Lilly is an equal opportunity employer and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected status.
#WeAreLilly
We encourage creativity, diversity, and innovation in our team, and we are committed to making a difference in global healthcare. Join us and be part of a team that makes life better for people around the world!
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