Senior Scientist/Engineer, Manufacturing Technology

Responsibilities

• Support the execution of biologics drug substance projects including commercial technology transfer
• Provide technical oversight of process design, process validation, and re-validation
• Author regulatory packages and support site regulatory inspections (PAI)
• Influence technical direction for manufacturing across media/buffer, cell culture, purification, and formulation
• Drive effective working relationships with Quality, Operations, Engineering, and Global Regulatory Science teams
• Deliver assigned projects across technical transfer and post-approval process changes

Requirements

• Bachelor's degree in engineering or science with 7–9 years of experience, or Master's with 4–6 years, or PhD with 2–4 years
• Experience in commercial technical support (MS&T, Manufacturing Engineering, or similar)
• Working knowledge of quality systems, Quality by Design (QbD), and validation principles
• Knowledge of global regulatory requirements for biologics drug substance processes
• Strong analytical, technical, and strategic thinking skills
• Excellent communication and stakeholder management abilities
• Proficiency in project management systems and tools

Preferred Qualifications

• Experience with technology transfer and Process Performance Qualification (PPQ)
• Strong understanding of biologics manufacturing processes from cell culture to fill through to freeze