Job Title: Process Development Engineer/Cell Culture Location: Thousand Oaks, CA Duration: 1 years contract JOB RESPONSIBILITIES: HYBRID 3/4 days onsite, 1-2 remote 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 Top 3 Must Have Skill Sets: Must have at-scale biologics cell culture experience Strong understanding of data analysis tools Excellent communication and troubleshooting Day to Day Responsibilities: Staff will perform tech transfer of early clinical candidate molecules.
In addition staff will support all processes(clinical and commercial) executed in the facility, performing process monitoring and responding to issues as appropriate.