Biomanufacturing Technical Expert

Job Number: R0250311

Biomanufacturing Technical Expert

To achieve an organization's mission, leaders need strong team members who can provide guidance on cutting-edge R&D, serve as a subject matter expertise, and develop innovative solutions throughout the execution of the mission. Whether completing an immediate task, advising on R&D, recommending a solution, or flexing to support an immerging requirement, our clients need someone who can help manage advanced biomanufacturing.

That is why we need you, an experienced Biomanufacturing Technical Expert, to provide technical expertise and project development for emerging opportunities within healthcare.

You’ll serve as a Biomanufacturing Technical Expert helping clients to develop technical R&D reports, evaluate advanced biological findings, and help determine viable solutions. You will be responsible for managing incoming requirements, facilitating engagements within offices and across the Agency, and being readily available to shift your focus to fulfill emerging client requests. Your attention to detail, flexibility, communication skills, understanding of the client's mission, and problem-solving will enable the mission's success.

• Analyze and develop reports on the state of the cutting-edge biomanufacturing for federal R&D programs.
• Support strategy development and program execution for biomanufacturing and related initiatives.
• Evaluate the conceptual and technical soundness of research programs spanning biomanufacturing in the health space.
• Provide subject matter expertise on innovative biomanufacturing equipment design, bioprocess design, unit operation integration, continuous bioprocessing in closed systems, automation, digital architecture, and current Good Manufacturing Practice (cGMP) and provide guidance on strategies for development of innovative biomanufacturing technologies.
• Provide subject matter expertise regarding upstream, downstream, and formulation of biological products, with an emphasis on genetic medicines such as therapeutics, gene, base, or prime editing such as CRISPR/Cas, or viral vector gene therapy.
• Perform literature reviews and generate briefing documents summarizing technical topics related to biomanufacturing.
• Assist in defining program goals, technical milestones, budgets, and performer expectations for high-impact scientific initiatives.
• Conduct technical reviews of R&D progress to ensure alignment with client objectives.
• Interact with clients, government officials, and other executives in various sectors.

Join us. The world can't wait.

• 5+ years of experience in biology or biomanufacturing
• Experience with bioprocess equipment design or integration, advanced process analytical technologies, automation, or supervisory control and data acquisition systems
• Experience with genetic medicines biomanufacturing such as therapeutic development,gene editing technology, or diverse biomanufacturing expertise in related modalities such as viral vectors or mAbs
• Experience supporting and advising government leadership or federal research programs
• Knowledge of chemistry manufacturing and controls (CMC), including process development and quality by design principles
• Ability to manage budgets, technical milestones, and multidisciplinary research efforts across multi-site or multi-performer programs
• Doctorate degree in Biological Sciences

• 7+ years of experience in biology or biomanufacturing
• Experience in the biopharma industry and working in a drug development environment and experience within designed biomanufacturing equipment or bioprocess design intended for FDA submissions
• Experience in the health, medical, or biological sciences spaces
• Experience operating within a federal R&D…