Bioprocess Engineer

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(Sr.) Bioprocess Engineer

Summary:

Seeking to hire a (Sr.) Bioprocess Engineer 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).

The company's lead product is GEN-1, a DNA-mediated immunotherapy for the localized treatment of ovarian cancer. Our newest program in development is a novel plasmid DNA-based investigational vaccine for preventing or treating infections from a broad range of pathogens including COVID-19 using our PLACCINE DNA vaccine technology platform.

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.