Full-Time Principal Scientist I

BryceTech is seeking a Principal Scientist I to support a high-visibility ASPR client. This role will manage over $21B in portfolio value.

Key Responsibilities:

• Support project team, acquisition program, and global health economic analysis.
• Develop and manage innovative government programs to expand the domestic industrial base for public health sector medical technology.
• Provide systems engineering and technical assistance to IBMSC in establishing and implementing a robust R&D program.
• Provide technical advice in developing environmental landscape analysis of current industry capacities.
• Define product domain requirements based on government threat assessments.
• Serve as technical lead (single point of contact) for the PMO / Tech Transfer portfolio.
• Develop technical transfer strategy for GMP activities at CMOs (across R&D, QC, QA, Regulatory, Supply Chain).
• Ensure project plans meet technical Regulatory/GMP standards.
• Support risk assessments and troubleshooting (OOS events).
• Lead communication and outreach to the research and development community.
• Communicate data and conclusions to the BryceTech team.
• Advice and assess testing and evaluation techniques.
• Lead cross-functional teams for process optimization, technology transfer, and investigations.
• Prepare, approve, and execute study and validation reports and protocols.
• Lead Quality by Design exercise and documents (process, IBMSC risk assessment).
• Contribute to Subject Matter Expert manufacturing investigations and process performance monitoring (Lifestyle Process Validation Stage 3 Continuous Process Verification).
• Provide technical input for SOPs and production records.
• Troubleshoot equipment and processes.
• Support the review of business systems and tools.
• Travel for official business as required.
• Proficient with MS Office and Adobe Acrobat.

Qualifications:

• Bachelor's degree (BS) in a scientific discipline (Chemistry, Biology, etc.) with 10 years experience, or graduate degree plus 5 years.
• 16+ years of relevant scientific experience (including biology, chemistry, data science).
• Experience developing technical transfer strategy for GMP activities at CMOs.
• Experience in pharmaceutical/medical device manufacturing with technical skills in manufacturing various products (solid oral dose, semi-solids, devices, biologics).
• Knowledge of GMP regulations and guidelines.
• Manufacturing process validation experience.
• Statistical analysis (JMP or Minitab knowledge a plus).
• Experience in Data Analytics, Computer Modeling, and Digital Applications.
• Excellent verbal and written communication skills.

Additional Information:

• Position contingent upon contract award (Fall 2025).

Benefits:

BryceTech offers comprehensive benefits (competitive salary, health plan, life/disability insurance, 401(k), educational reimbursement).

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