Principal Scientist, Drug Product Sterile Solutions

Position Summary

You will lead scientific work to develop safe, stable, and manufacturable drug product sterile solutions, including mAbs and oligonucleotides. You will design and run studies, interpret results, and make clear recommendations. You will work closely with colleagues across science, regulatory, and supply teams.

Responsibilities

• Design, plan and execute formulation and process development studies for sterile and complex drug products.
• Interpret experimental results and provide clear recommendations to project teams.
• Lead stability, compatibility, and container-closure assessments to support regulatory submissions.
• Prepare technical reports, study protocols, and documentation needed for product development and transfer.
• 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.
• Opportunities to publish research and influence industry approaches.

Qualifications

• PhD in Pharmaceutics, Chemical Engineering, Biomedical Engineering, Chemistry, or related scientific discipline; or MS with 5+ years’ relevant experience; or BS with 10+ years’ relevant experience.
• Experience in formulation and process development for sterile or complex drug products.
• Experience designing and executing stability and compatibility studies.
• Strong data analysis skills and experience interpreting physicochemical and analytical results.
• Experience authoring technical reports and contributing to regulatory documentation.

Preferred Qualifications

• Experience with biologics, oligonucleotides, or advanced delivery systems.
• Experience with container-closure integrity and primary packaging assessments.
• Experience with technology transfer and scale-up to manufacturing.
• Experience statistical design of experiments (DOE) and technical risk assessment methods.
• Experience contributing to regulatory submissions and responding to regulatory questions.
• Strong collaboration and influencing skills in matrix team environments.

Benefits

The comprehensive benefits program includes:

• Flexible working arrangements.
• Health, wellness, and financial support programs.
• Professional development opportunities.
• Community engagement initiatives.