Process Development Engineer

Target PR Range: 30-40/hr
*Depending on experience

The ideal candidate will be a Process Development Engineer with a strong foundation in upstream biologics, including suspension cell culture, bioreactor operations, and monoclonal antibody production. The engineer will join the Drug Substance Technology Engineering team, supporting the development and manufacturing of human therapeutic products from clinical stages through commercial production. They will apply process engineering knowledge to support technology transfer and manufacturing in an advanced suite utilizing single-use technology. The ideal candidate will hold a bachelor’s degree in Engineering, Biology, or a related scientific field with 2 to 5 years of relevant experience, or a master’s degree with new graduates considered. They should be proficient in data and statistical analysis tools such as JMP, possess excellent communication skills, and thrive in cross-functional collaboration. Comfort working in a regulated, fast-paced environment and presenting technical data to diverse teams is essential. Candidates who are remote only, lack upstream experience, have excessive short-term job history, or come from non-scientific or non-engineering backgrounds should be avoided.

JOB RESPONSIBILITIES:
Under guidance of senior staff, the Engineer performs the following:
- Transfer cell culture processes for drug substance manufacturing and performs process improvements from the laboratory into the manufacturing facility
- Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
- Offer process validation support for late stage commercial processes
- Provide routine process monitoring and troubleshooting
- Execute data trending and statistical process analysis
- Support technical direction for process related deviations, CAPAs and change controls
- Identify and support process related operational excellence opportunities
- Represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory

BASIC QUALIFICATIONS:
Master’s degree
OR
Bachelor’s degree and 2 years of Engineering or Operation experience
Associate’s degree and 7 years of Engineering or Operations experience
OR
High school diploma / GED and 8 years of Engineering or Operations experience

PREFERRED QUALIFICATIONS:
• Master’s Degree in Chemical or Biochemical Engineering
• 1+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities
• Background in biologics tech transfer into commercial facilities
• Cell culture process knowledge: Knowledge of cell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes
• Strong capability of analysis, troubleshooting and problem solving
• Ability to develop and follow detailed protocols
• Independently motivated with ability to multi-task and work in teams
• Excellent written and verbal communication skills with technical writing and presentation experience