Job Description

• Candidate will be required to be on site 3-4 days a week and may work remotely 1-2 days a week (activities permitting).
• Must have biotech background/experience, plus must have cell culture/purification experience
• The ideal candidate:
  • Has experience in a dynamic, fast based manufacturing environment adaptability.
  • Can jump around and pivot in their role with ease
  • Can sit in an open office and collaborate with team.
  • Understand the language and compliance in a large scale manufacturing plant
  • Trouble shoot, problem solving and data analysis.
  • Great communicator good technical witting and presentation experience
  • Minimum Bachelor degree and 2 years of experience with antibodies or biologics.

• Cell culture bioreactors - monitoring of at-scale bioreactor process/equipment. Or
• Purification processes/ equipment; chromatography, UF/DF Ultra filtration and Dia filtration.
• Experience working in a GMP plant and quality systems

• Provide on-the-floor technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
• Provide routine process monitoring and troubleshooting
• Perform data trending and statistical process analysis
• Provide technical support for process related deviations (NCs), CAPAs and change controls
• Identify and support process related operational excellence opportunities
• Represent process development and interface with other functions such as Manufacturing, Quality, and Regulatory

• Under guidance of senior staff, the Engineer performs the following:
  • Transfer cell culture and/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

• Master degree OR
• Bachelor degree and 2 years of experience OR
• Associate degree and 6 years of experience OR
• High school diploma / GED and 8 years of experience

• Bachelor degree Chemical or Biochemical Engineering and 2 years of experience GMP Environment
• 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 and/or Purification process knowledge:
  • Knowledge of purification processes/ equipment; scale up factors from, chromatography, UF/DF, process deviations, raw materials to growth and quality attributes
  • 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

• Wants remote work only.
• No on-the-floor support experience.
• No scientific background.
• Only pharmaceutical and no biologics experience.
• No cell culture or protein purification experience.
• no process dev or process engineering

• Phone interview 1:1 start screening ASAP.
• 1:3 panel or series of 1:1s