Engineer, Biopharma Process Development – Hybrid; JP

Position: Engineer, Biopharma Process Development – Hybrid (JP10873)
Job Title:Engineer, Biopharma Process Development – Hybrid (JP10873)
Location:Thousand Oaks, Ca. (3-4 days onsite/1-2 days remote)
Employment Type:Contract
Business Unit:Process Development - Upstream (Clinical)
Duration:12 months with possible extension of conversion to FTE
Posting Date:10/3 /2022

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
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.

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 OR Associate’s degree and 7 years of Engineering or Operations experience

Preferred Qaulifications:

• 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

Why is the Position Open?
Staff Augmentation.

Top 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.

Employee Value Proposition: Career, growth, opportunity

Red Flags:

• Candidate should have scientific background
• Multiple short-term work experience
• Lack of cell culture experience
• Non science background/degree

Interview process:
Phone screen followed by Video interview.

We invite qualified candidates to sendyour resume to. Ifyou decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our  You are welcome to also sharethis opportunity with anyone you think might be interested in applying for this role.
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