Biomanufacturing Technology Expert

Biomanufacturing Technology Expert

Key Role: 

Support federal health research and development (R&D) organizations, including the Advanced Research Projects Agency – Health (ARPA-H), as a Technical Science, Engineering, and Technology Adviser (SETA) for programs related to innovative biomanufacturing technologies. Apply scientific and engineering subject matter expertise to help conceptualize, create, and execute advanced government-funded R&D programs to accelerate better health outcomes for everyone. Characterize the state of a technical field, including identifying state-of-the-art technologies and promising new approaches. Perform analyses to recommend ambitious technology performance and cost targets that are on the cutting-edge of what might be achievable. Identify key technical experts across academia, industry, and national labs, perform technical outreach, and facilitate the formation of new multi-disciplinary technical communities. Review highly technical proposals and support negotiations of selected projects, including advising on project plans and technical milestones for complex R&D projects. Perform direct and periodic technical oversight of the project portfolio, from set-up to close-out, and assist the client with managing projects to achieve clear and compelling outcomes.  

Basic Qualifications:  

• 3+ years of experience with biomanufacturing equipment design, bioprocess design, unit operation integration, continuous bioprocessing in closed systems, automation, digital architecture, or current Good Manufacturing Practice (cGMP) in the post-doctoral or post-medical lab industry

• Experience with upstream, downstream, and formulation of biological products, including genetic medicines, such as mRNA and DNA vaccines, or therapeutics, gene, base, or prime editing, such as CRISPR or Cas, or viral vector gene therapy

• Experience with searching across multiple databases, data repositories, web portals, search engines, and scientific journal platforms 

• Knowledge of chemistry manufacturing and controls (CMC), including process development and quality by design principles

• Ability to ask insightful questions that challenge traditional thinking

• Ability to obtain and maintain a Public Trust or Suitability/Fitness determination based on client requirements

• Doctorate degree in Biomanufacturing, Bioprocessing, Biotechnology, or Biochemistry 

Additional Qualifications:  

• 10+ years of experience with working in a professional environment

• Experience with bioprocess equipment design or integration, advanced process analytical technologies, automation, and supervisory control and data acquisition systems

• Experience with genetic medicines biomanufacturing such as mRNA vaccines, DNA vaccines, or gene editing technology

• Experience with cGMP and IND filing of biological products, visualization techniques, tools, and data analytics, and biomanufacturing in modalities such as viral vectors or mAbs

• Experience in support of or related to an Advanced Research Projects Agency (ARPA) organization, including DARPA, IARPA, ARPA-E, or ARPA-H

• Experience in a consulting environment 

• Ability to develop and convey meaningful insights, significant contributions, and recommendations to address complex client issues 

• Ability to learn, grow, and develop new skill sets, and display creativity and resourcefulness 

• Possession of excellent data gathering, analytical, problem-solving, and client service skills

• Possession of excellent verbal and written communication skills 

Vetting:

Applicants selected will be subject to a government investigation and may need to meet eligibility requirements of the U.S. government client.

Compensation

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