Principal Scientist, Global Process Development, Drug Product Development and Delivery
On-siteMalvern, Pennsylvania, United States
Job Summary
Lead global technical efforts for Antibody Drug Conjugate (ADC) drug product development, establishing scalable platforms, Quality by Design practices, and control strategies from preclinical through commercialization stages. Drive process development and lifecycle management, including formulation, aseptic manufacturing, lyophilization, and technology transfer across internal sites and CDMOs. Resolve complex manufacturing issues, support investigations and CAPAs, and author Chemical, Manufacturing, and Controls (CMC) sections for regulatory submissions aligned with FDA, EMA, and ICH guidelines. Partner with cross-functional teams including Quality, Regulatory, and Supply Chain to advance phase-appropriate development roadmaps for bioconjugate assets.
Required Qualifications
- A minimum of a Bachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biotechnology, or a related field
- 8+ years of relevant biopharmaceutical experience
- 8+ years of sterile drug product process development and manufacturing experience
- A Master's degree with 6+ years
- A PhD with 4+ years
- Proven expertise in bioconjugate (ADC) lifecycle
- Advanced aseptic processing
- Sterile manufacturing
- Process scale-up
- Technology transfer
- Process characterization
- Validation
- Risk management
- Control strategy
- Statistical process/data analysis
- 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
- Global GMP regulations
- 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
Desired Qualifications
- Master's degree preferred
- PhD preferred
- 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
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