Engineer – At scale cell culture operations (JP7817)
Thousand Oaks, CA. (Onsite essential pending lifting of COVID restrictions)
ATO Process Engineering
1+ years (with likely extensions)
3 Key Consulting is hiring an Engineer
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
*Candidate will be remote until the site re opens & will then be required to be on site M-F
We are looking for a candidate who can work on the culture side of manager’s process engineering team. The ideal candidate has 1-3 years in a process engineering function supporting at-scale cell culture operations, monitoring trends for weak signals, and providing technical oversight of production and production issues. If the candidate comes from the lab, they should be running small scale bioreactor studies and be able to discuss how a bioreactor works and how they consume the data and analyze it. If they come from manufacturing, they need 3-5 years (or more) in manufacturing to get to the level of expertise we are looking for.
Seeking a Process Development Engineer to join the Drug Substance Process 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. Responsibilities under guidance of senior staff will include:
Why is the Position Open?
- Transfer cell culture or 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 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.
Top Must-Have Skill Sets:
Day to Day Responsibilities:
- At-scale biologics cell culture.
- 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.
Associate’s degree and 7 years of Engineering or Operations experience
High school diploma / GED and 8 years of Engineering or Operations experience
- 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.
- Upstream process knowledge.
- Knowledge of cell culture or purification processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, chromatography, UF/DF, process deviations, raw materials to growth and quality attributes OR
Employee Value Proposition:
- 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.
High level technical exposure to cross functional teams within our client’s organization.
Multiple short duration jobs on resume.
Video Skype Panel 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 particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.