Principal Scientist, Product Champion

Scorpion Therapeutics; New Brunswick (NJ); On-site; USD 124,000 - 150,000; Full time

Benefits offered by this job

Health coverage

401(k)

Disability/life insurance

Paid time off

Job summary

Scorpion Therapeutics seeks a Product Champion to provide technical leadership for sterile drug products and oversee lifecycle management within a matrix Drug Product team. The role drives the drug product book of work, ensures product robustness, and supports global change controls and regulatory filings.

The successful candidate will have extensive biologics/aseptic processing experience, strong writing and communication skills, and the ability to navigate a matrix organization while traveling

Qualifications

• Bachelor's degree with 9+ years of 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, and critical thinking.

Responsibilities

• Lead Aseptic Drug Product matrix team for sterile products; represent DP on technical matters at 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., TOR).
• Review/co-author CMC filings and IRs.
• Co-author End-to-End Robustness and End-to-End Annual PQRs; own robustness action plan.
• Drive technology transfer project definition; support technology transfer docs and resolve roadblocks.
• Drive DP strategy/direction; demonstrate leadership in matrix environments.
• Work independently with little direction; up to 30% travel.

Skills

Technical leadership

Matrix leadership

Technical writing

Verbal communication

Critical thinking

Independent work

Education

Bachelor's degree

Master's/PhD preferred

Job description

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.