Principal Scientist, Product Champion

Position Summary

Product Champion provides technical leadership for new or existing sterile drug products. Accountable for lifecycle management product(s), leading a matrix Drug Product team, driving the drug product book of work (BOW), and ensuring product robustness and process monitoring.

Key Responsibilities

• Lead Aseptic Drug Product matrix team for sterile products; represent Drug Product on technical matters at Technical Product Team (TPT).
• Manage DP book of work and risk register.
• Support sites with significant quality events and provide input for complex change controls.
• Endorse global change controls; support Global Change Control impact assessments.
• Accountable for lifecycle documents (e.g., Time Out of Refrigeration (TOR)).
• Review/co-author CMC filings and Information Requests (IRs).
• Co-author End-to-End Robustness and End-to-End Annual Product Quality Reviews; own robustness action plan.
• Drive technology transfer project definition; support technology transfer documents and resolve roadblocks.
• Drive DP strategy/direction; demonstrate leadership in matrix environments.
• Work independently with little direction; up to 30% travel.

Required Qualifications & Experience

• Bachelor’s + 9+ years relevant experience (Master’s/Ph.D. preferred).
• In-depth knowledge of biologics/sterile liquid drug products and aseptic processing.
• Experience in biologics/vaccine aseptic drug product manufacturing and/or technology transfer.
• Strong technical writing, verbal communication, critical thinking.
• Ability to serve as a technical expert; work independently; operate effectively in a matrix.
• Influence without direct control; decision-making for complex problems.

Desired

• Lyophilization expertise.
• Quality systems, Quality by Design, validation, process control; Statistical Process Control tools.
• Regulatory filings/Health Authority question experience.

Compensation/Benefits (as stated)

• $123,580–$149,752 (New Brunswick, NJ, US). Health coverage, wellbeing support, 401(k), disability/life insurance; paid time off options.

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