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Engineer, Biopharma - At-scale biologics purification (JP9474)

Thousand Oaks, CA · Biotech/Pharmaceutical

Job Title:  Engineer, Biopharma - At-scale biologics purification (JP9474)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit: Process Development, Manufacturing Support.
Duration: 1+ years with likely extensions or conversion to FTE
Posting Date: 11/23/2021

Notes: Candidate will be required to be on site 4-5 days a week and may work remotely 1-2 days a week.

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description: 
We are looking for a
Process Development Engineer to join the Drug Substance Technology Engineering team at our client’s 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 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.

Responsibilities under guidance of senior staff will include:
  • Transfer 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 

Why is the Position Open?
Additional workload.
Top Must-Have Skill Sets:
  • At-scale biologics purification knowledge and experience
  • Strong understanding of data analysis tools
  • Excellent communication and troubleshooting

Day to Day Responsibilities:
The person in this role will help manufacture clinical and commercial molecules. There are many unique opportunities to work on different programs.
Basic Qualifications: Master’s degree OR Bachelor’s degree

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.
  • 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
  • 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. 
Employee Value Proposition:
The person in this role will help manufacture clinical and commercial molecules. There are many unique opportunities to work on different programs
Red Flags:

Multiple short duration jobs on resume
No purification experience
Interview process:
Phone and Video Panel Interview
We invite qualified candidates to send your resume to 
resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

3KC Talent Acquisition Team
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