Principal Scientist, Product Characterization – Advanced Therapies
On-siteMalvern, Pennsylvania, United States or Leiden, South Holland, The Netherlands
Job Summary
Define and implement product characterization strategies for in vivo CAR-T, LNP, mRNA, and targeted LV modalities from early to late development stages. Lead the identification and justification of Critical Quality Attributes using Quality by Design principles, while executing advanced methodologies for comparability and deep characterization of cell and gene therapies. Develop control strategies linking process parameters to CQAs and apply DOE and statistical modeling to establish structure-function relationships. Author regulatory sections for IND/IMPD/BLA/MAA and communicate findings to cross-functional teams and health authorities. Mentor junior scientists in experimental design and data interpretation while collaborating with Process Development, data sciences, and Quality Assurance. Contribute to internal and external technical forums and standard operating procedures for advanced therapy product characterization.
Required Qualifications
- Ph.D. or equivalent advanced degree in Biochemistry, Immunology, Virology, Biological Science, or a related field with 3+ years of proven experience in biopharmaceutical development
- Bachelor's or Master's degree with 6-8 years of relevant experience
- 2+ years of analytical control strategy experience on advanced therapy medicinal products (ATMP) such as CAR T, lentiviral vectors and gene therapy products
- Demonstrated expertise in CQA assessment and developing control strategies for advanced therapies
- Experience with the design, execution and optimization of a broad range of analytical techniques for orthogonal characterization of cell therapy and gene therapy products
- Detail-oriented, highly organized and able to manage multiple tasks, handle tight timelines and deliver quality data
- Strong written and verbal communication skills with the ability to convey complex scientific concepts clearly
- Ability to mentor and guide junior scientists and technicians in experimental design, data interpretation, and quality assurance practices
- Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment
- Ability to work collaboratively in a complex, matrix environment
- 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
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