Senior Scientist – Analytical Container Closure Integrity

About the role

The Center for Packaging & Device Analytics (CPDA) in West Point, PA seeks a senior scientist to lead analytical work on container closure integrity (CCI) for sterile packaging and combination products. The role focuses on method development, validation, and technical support across late‑stage development and global manufacturing.

Key responsibilities

• Characterize new package or device components to guide selection and optimization.
• Develop, validate, and transfer CCI analytical methods such as dye ingress, high‑voltage leak detection, vacuum/pressure decay, laser headspace, and tracer‑gas analysis.
• Provide lifecycle support and method transfers for manufacturing sites.
• Offer in‑depth technical assistance to resolve CCI‑related analytical and manufacturing investigations.
• Expand CCI analytical capabilities within the CPDA.

Required profile

• BS, MS or PhD in Mechanical, Chemical, Biomedical Engineering or related physical chemistry discipline.
• Minimum 5 years of relevant experience in pharmaceutical, biotechnology or medical‑device industries, or a PhD with comparable experience.
• Familiarity with CCI testing in industrial or academic settings.
• Knowledge of USP <1207>, ISO‑13485 and related industry standards.

Required skills

• Analytical method development and validation.
• Container Closure Integrity testing (dye ingress, high‑voltage leak detection, vacuum/pressure decay, laser headspace, tracer‑gas analysis).
• Hands‑on troubleshooting of CCI methods for packaging and medical‑device products.
• Understanding of regulatory standards such as USP <1207> and ISO‑13485.

What we offer

• Competitive salary range $117,000‑$184,200 with annual bonus and long‑term incentives.
• Comprehensive benefits including medical, dental, vision, 401(k), paid holidays, vacation and sick leave.