Scientist/Engineer Technical Advisor (SETA) (Biopharmaceutical/Nucleic Acid Manufacturing)

Seeking a Biomedical Research Scientist/Engineer to serve as a Scientific Engineering Technical Advisor (SETA) to support an ARPA-H Program Manager and work in our Remote office.

Are you a passionate scientist with experience in biopharmaceutical or nucleic acid manufacturing with at least 5 years of industry experience in the biopharmaceutical or biomanufacturing industry? Are you ready to support the Advanced Research Projects Agency for Health (ARPA-H) in their mission to accelerate better health outcomes for everyone by supporting complex and leading-edge R&D projects designed to arrive at high-impact solutions to society's most challenging health problems?

In this role, you will collaborate with the ARPA-H Program Manager and team to effectuate bold ARPA-H research initiatives in gene and cell therapies and execute government funded research and development programs to meet ARPA-H’s mission to accelerate better health outcomes for everyone. More detailed requirements below.

These SETA duties include but are not limited to:

• Search and review industrial, scientific, and technical literature in areas of development and manufacturing of DNA, RNA, and viral vectors for therapies.
• Analyze technical, scientific, regulatory, and technoeconomic data with respect to novelty, rigor, and robustness.
• Clearly and concisely synthesize takeaways. Compare and contrast technical approaches and innovations.
• Under the leadership of an ARPA-H Program Manager (PM) and working with a team, build and maintain detailed program plans.
• Write and review technical documents and solicitations.

Qualifications:

• A degree (BS, MS, or PhD) in chemistry, biology, biomedical engineering, or related fields.
• Minimum 5 years of industry experience in the biopharmaceutical or biomanufacturing industry with the focus on manufacturing, regulatory, technical operations, process development, product development or other related areas.
• Excellent MS Excel and PowerPoint skills are required.
• Ability to integrate, process, analyze, and synthesize search data.
• Excellent technical writing and communication skills
• Ability to meet deadlines
• Willingness to work in a high-paced environment
• Intellectual curiosity and interest in expanding knowledge to new scientific areas
• Ability and willingness to brainstorm with other colleagues to find alternative solutions to scientific/technical problems
• Must be willing to quickly adapt to shifting priorities, demands, and timelines
• Travel is expected.

Additional Experience:

• Knowledge of the current FDA regulations is a plus.
• Commercialization experience (for example, technology transfer, pharma business development, competitive intelligence, portfolio planning, intellectual property support, etc.) is a plus.
• CDMO (Contract Development and Manufacturing Organization) or GMP (Good Manufacturing Practice) lab experience is a plus.
• Techno-economic analysis experience is a plus.
• Lab experience or working knowledge of current production methods of DNA, RNA, and viral vector products is a plus.
• The knowledge of or experience with fully synthetic, enzymatic, and cell-based production methods is a plus.