Eli Lilly and Company · 10 hours ago
Principal Process Engineer, Parenteral Drug Product Development
Indianapolis, IN
Full-time
Onsite
Senior Level, Lead/Staff
$80K/yr - $148K/yr
3+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and delivering life-changing medicines. They are seeking a highly motivated Principal Process Engineer for their Biologics Drug Product Development team, responsible for developing parenteral drug product manufacturing processes and collaborating with cross-functional teams to support clinical manufacturing and regulatory submissions.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
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
Qualification
Required
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, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
Preferred
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
Benefits
Company bonus
Company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-02-04
2026-02-04
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