Principal Process Engineer, Parenteral Drug Product Development

Principal Process Engineer, Biologics Drug Product Development

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. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

The main purpose and objectives of the Lilly Bioproduct Research and Development (BR&D) organization is focused on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. The organization is also committed to the development of genetic medicines which includes active investments in oligonucleotide development, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in building new platforms to support complex formulations such as lipid nanoparticles (LNPs), antibody drug conjugates, AAV, and other non-viral vector delivery vehicles.

We are seeking a highly motivated candidate for the position of Principal Process Engineer, Biologics Drug Product Development, located in Lilly Technology Center, Indianapolis.

Responsibilities

• 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.

Basic Requirements

• B.S. or M.S. in Pharmaceutical Chemistry or Engineering with related industry experience. B.S. with minimal 5 yrs and M.S. with minimal 3 yrs experience.
• Working knowledge and understanding of parenteral product development is required.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role.

Additional Preferences

• Good understanding of cGMP requirements, and ICH guidelines is highly preferred.
• Good understanding of stability and potential degradation pathway of protein and peptides, etc. is a plus.
• Working knowledge and experience in handling and developing ADC and mRNA LNP manufacturing process is highly preferred.
• Sound understanding of statistics and data management is a plus.
• Effective oral and written communication skills are essential.

The physical demands of this job are consistent with a lab environment. The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

This position's work environment is in a laboratory environment. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $79,500 - $148,500. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees.