Bioprocess Engineer

Summary

Imunon is seeking to hire a Bioprocess Engineer at its Huntsville, AL, site to support the company’s ongoing development of novel immunotherapies. The position will play an integral role in the establishment of a GMP manufacturing facility to produce plasmid DNA active pharmaceutical ingredient (API).

Duties and responsibilities

  • Lead the development of pilot scale downstream processing (DSP) unit operations of plasmid DNA from bacterial cell paste (from 10 L – 100 L bioreactor fermentation), to include lysis, clarification, ultrafiltration/diafiltration, and ion exchange chromatography.
  • Plan and execute structured process development experiments to achieve the target yield, process optimization, product quality, scale-up and process robustness objectives.
  • Play a pivotal role in the establishment of a GMP manufacturing facility to produce plasmid DNA active pharmaceutical ingredient (API).
  • Document work thoroughly with a detail-oriented approach, write concise technical reports, and make effective presentations to management and other team members.
  • Translate developed processes into standard operating procedures (SOPs) as well as necessary calibration and preventive maintenance SOPs.
  • Write validation protocols and lead the technical support staff to successfully execute IQ, OQ, and PQ.
  • Lead the process transition into the new facility.
  • Troubleshoot, optimize, and improve ongoing process activity with scientific curiosity.
  • Research literature and keep current with current bioprocessing industry standards, technical advancements, and regulatory requirements.
  • Prioritize responsibilities, multi-task, and remain flexible with changing objectives.
  • Operate effectively under the pressure of meeting demanding deadlines in a dynamic technical environment.

Experience

The successful candidate will have:

  • B.S. or M.S. degree in Biochemical/Chemical Engineering preferred. Will also consider other disciplines such as biology, chemistry, or related field with requisite experience.
  • 4+ years of hands-on biopharmaceutical experience at pilot or commercial scale with bioreactor fermentation (USP) and DSP of plasmid DNA from bacterial cell paste, including lysis, clarification, ultrafiltration/diafiltration, and ion exchange chromatography.
  • 2+ years of experience working in a GMP manufacturing environment. Candidates with supervisory experience are preferred.
  • Significant experience using ultrafiltration and diafiltration with tangential flow filtration (TFF) in a DSP unit operation.
  • Sound understanding of plasmid DNA biochemistry in microbial hosts relevant to downstream purification.
  • Understanding of engineering issues related to process scale-up (10 to 100 L fermentation scale or higher) and ability to apply both practical and analytical skills to develop new processes.
  • Working knowledge of Microsoft Office software, particularly Word and Excel required. Experience with advanced graphing and/or statistical software such as GraphPad Prism is beneficial.
  • Experience authoring technical reports and presentations to enable management evaluation.

Benefits

  • Health and Dental insurance, matching 401k, and generous PTO for eligible employees.

To apply, please send your resume to careers@imunon.com