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Manager, Bioprocess Development & Manufacturing
Huntsville, AL

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Summary:

Company is seeking to hire a Manager, Bioprocess Development & Manufacturing 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).

Company:

We’re a fully integrated biopharmaceutical company focused on developing a portfolio of innovative treatments for cancer and infectious diseases using our DNA-mediated gene transfer technologies.

Our 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.
  • 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.
  • Provide significant input and direction to the build-out of a new pilot-scale manufacturing operation from the ground-up, including operational management systems, quality processes, and personnel decisions.
  • Lead the process transition into the new facility.
  • Provide daily direction to operators in the safe and compliant production of plasmid DNA from bacterial fermentation.
  • Provide supervision of the team, including training, personal development, and evaluation.
  • Control inventory of raw materials, consumables, and waste streams within the working environment according to company SOPs.
  • Ensure batches are manufactured in accordance with cGMPs, batch records, procedures and completed according to schedule and budget
  • Perform batch record review in a thorough and timely manner.
  • Write validation protocols and lead the technical support staff to successfully execute IQ, OQ, and PQ.
  • 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.


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