Job Description
Company is seeking to hire a 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).
• 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.
Qualifications
• 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.
Additional Information
Competitive salary, bonus, stock, relocation and benefits are offered.
