Biologics Process Development Engineer – Purification & Technology Transfer - (JP15447)
About The Position
Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client’s Thousand Oaks, CA. facility. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. The Engineer will apply harvest and purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.
Requirements
- 2 YOE post graduation required
- At- scale biologics purification knowledge and experience
- Strong understanding of data analysis tools
- Excellent communication and troubleshooting
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Nice To Haves
- 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
- Purification process knowledge
- Knowledge of purification processes/equipment; scale-up factors from chromatography, UF/DF, 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
Responsibilities
- Transfer purification drug substance processes 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 operations
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
