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Engineer/Cell Culture - Thousand Oaks, United States - ACL Digital
Description
Job Title: Process Development Engineer/Cell Culture
Location: Thousand Oaks, CA/Hybrid
Duration: 12 Months
Description:
HYBRID 3/4 days onsite, 1-2 remote. USTO. Standard Business hours with some after-hours support on call by manufacturing potentially twice a month for 2-4 hours.
*Candidate will be required to be on site 3-4 days a week and may work remotely 1-2 days a week (activities permitting).
Top 3 Must Have Skill Sets:
Must have at-scale biologics cell culture experience (manufacturing experience, engineering experience)
Strong understanding of data analysis tools (JMP preferred)
Excellent communication and troubleshooting (Must be comfortable presenting data & technical information to a group of 20+ people. Presenting at min once per month to quarter)
Ideal candidate: 1-2 years of industry experience, comfortable presenting and social, Upstream cell culture experience required not just purification. 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. GMP experience is a huge plus - someone who has dealt with regulatory inspectors/auditors (FDA, other regulatory agencies from other countries)
Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Thousand Oaks 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 cell culture 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.
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:
Masters degree
OR
Bachelors degree and 2 years of Engineering or Operation experience
Associates degree and 7 years of Engineering or Operations experience
OR
High school diploma / GED and 8 years of Engineering or Operations experience
PREFERRED QUALIFICATIONS:
Masters 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
Basic Qualifications
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
