Principal Scientist, Global Process Development, Drug Product Development and Delivery

About the role

We are searching for the best talent for a Principal Scientist, Global Process Development, Drug Product Development and Delivery to be located in Malvern, PA.

Purpose

We are seeking an authority and highly motivated Global Principal Process Scientist to provide global technical leadership for the development, scale-up, transfer, validation, and commercialization of Antibody Drug Conjugate (ADC) drug product manufacturing processes. This individual will support both early-stage clinical development and late-stage/commercial programs, ensuring robust, scalable, conformant, and patient-centric manufacturing processes.

Qualifications/Requirements

• Education: A minimum of a Bachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biotechnology, or a related field with 8+ years of relevant biopharmaceutical experience, including 8+ years of sterile drug product process development and manufacturing experience; OR a Master's degree with 6+ years; OR a PhD with 4+ years is required.
• Experience And Skills:
  • Technical Expertise: Proven expertise in bioconjugate (ADC) lifecycle, spanning advanced aseptic processing, sterile manufacturing, process scale-up and technology transfer, process characterization and validation, risk management, control strategy, and statistical process/data analysis is required.
  • Regulatory Knowledge: Strong understanding of FDA, EMA, PMDA, and Health Canada expectations; ICH guidelines Q8, Q9, Q10, Q11, and Q12; process validation lifecycle principles; commercial readiness requirements; and global GMP regulations is preferred.

Qualifications/Requirements - Continued

• Preferred Skills: Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Coaching, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific Research