Process Development Engineer-Upstream/Cell Culture

3 weeks ago

Thousand Oaks, United States Infotree Global Solutions Full time

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).

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)

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)

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: 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

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