Principal Scientist- Sterile and Drug Product Development
HybridCollegeville, Pennsylvania, United States
Job Summary
Design, plan, and execute formulation and process development studies for sterile and complex drug products, including long-acting injectables, antibody drug conjugates, and oligonucleotides. Develop phase-appropriate formulations to support clinical studies and commercialization while interpreting experimental results to provide clear recommendations to project teams. Lead drug product development matrix teams, conduct stability and compatibility assessments, and prepare technical reports and documentation for regulatory submissions. Work across functional teams and external partners to support scale-up, technology transfer, and launch readiness. Mentor colleagues, review data quality, and contribute to continuous improvement of lab practices.
Required Qualifications
- PhD in Pharmaceutics, Chemical Engineering, Biomedical Engineering, Chemistry, or related scientific discipline
- MS with 5+ years' relevant experience
- BS with 10+ years' relevant experience
- Experience in formulation and process development for sterile, long acting injectables, protein or complex drug products
- Experience designing and executing stability and compatibility studies
- Experience with Data analysis and interpreting physicochemical and analytical results
- Experience authoring technical reports and contributing to regulatory documentation
- You will be expected to work on-site part of the week
- Reasonable travel may be required
Desired Qualifications
- Experience with long acting injectables, ADC, biologics, oligonucleotides, or advanced delivery systems
- Good understanding of physico-chemical, biological properties and biopharmaceutics
- Experience in sterilization techniques
- Familiarity with container-closure integrity and primary packaging assessments
- Experience with technology transfer and scale-up to manufacturing
- Knowledge of statistical design of experiments (DOE) and technical risk assessment methods
- Experience contributing to regulatory submissions and responding to regulatory questions
- Familiar with cGMP and regulatory requirements for manufacturing operations and documentation
- Strong collaboration and influencing skills in matrix team environments
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