Senior/Principal Process Engineer - API External Manufacturing Peptides

About the role

The position of API EM Engineer [Synthetic Peptide Synthesis and Purification] reports to the API EM Engineering Associate Director and provides technical leadership and expertise in conjunction with API EM contract manufacturer personnel in the reliable supply and commercialization of medicines with safety first and quality always by:

Responsibilities

• Developing and sustaining process knowledge in order to ensure the execution of the appropriate product, process, and operational control strategy at a number of Contract Manufacturers (CMs)
• Direct and indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy
• FUME assessment to ensure an understanding of risk presented to the operational control strategy
• Participation with internal or CM resources in the equipment specification, procurement, and IQ/OQ/PQ
• Participation with internal and CM resources to assess the HSE and PSM elements of the CM that impact Lilly products
• Engaged with internal and external resources in developing capabilities with new or evolving technologies that may impact delivery of internal or external portfolio assets.
• Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EM’s CMs.

Qualifications

• Bachelor of Science degree in Chemical Engineering, or another engineering discipline with 5 years chemical manufacturing experience
• 3+ years of work experience in a manufacturing/process engineering related to peptides or small molecules
• Qualified applicants must be authorized to work in the United States on a full-time basis.

Skills

• Demonstrated experience in scale-up and/or technology transfer (internal plant or external CMO)
• Deep technical knowledge of API / Drug Substance manufacturing equipment and unit operations
• Experience with SM and/or peptide unit operations and purification/isolation steps relevant to drug substance manufacturing
• Experience in typical unit operations for API Manufacturing manufacturing
• Visualize an operation/process and reflect it in a model
• Successful application of root cause analysis and systematic problem solving
• Strong Computer skills in a variety of software packages (e.g. Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office Suite)

Benefits

No specific benefits mentioned in the job posting.

Pay

$66,000 - $171,600

Schedule

The normal schedule for this position is Monday-Friday, 8 hours/day. However, teleconferences may routinely occur outside of these hours due to the time zones of contract manufacturers. OUS travel may routinely be required to support process start-ups, troubleshooting, and commercial manufacturing. This travel is typically in the range of 15% to 25% annually, depending on the needs of the process(s).