Job Title: Engineer, Biopharma At-scale Cell Culture purification - (JP9477)
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 12 months with likely extensions
Business unit: Process Engineering
Job posting date: 11/22/2021
- Candidate will be required to be on site 4-5 days a week and may work remotely 1 days a week (activities permitting).
- 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 or 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.
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
- Master’s degree OR
- Bachelor’s degree and 2 years of Engineering or Operation experience OR
- Associate’s degree and 7 years of Engineering or Operations experience OR
- High school diploma / GED and 8 years of Engineering or Operations experience
Top Must have Skill Sets:
- 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
- Must have at-scale biologics cell culture experience
- Strong understanding of data analysis tools
- Excellent communication and troubleshooting
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.
Employee Value Proposition:
- Learn new technologies and able to get trained by pharm industry
- Great trainings
- Multiple short-term work experience
- Lack of cell culture experience
- Looking for a degree in Chemical or Biochemical Engineering
1: Employer will phone screen the candidates
2: Video interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.