Senior Scientist, I

Senior Scientist position focused on developing and optimizing drug delivery systems and combination medical devices. Responsibilities include experimental design, process development, scale-up activities, and cross-functional collaboration with internal teams and contract manufacturers.

Responsibilities

• Design and execute experimental protocols, design of experiments, and functional tests for device systems
• Support lab scale-up activities and technical transfer with contract manufacturing organizations
• Develop risk assessments, test plans, and analyze results for design verification and validation
• Create and review technical documentation including SOPs, batch records, and validation protocols
• Troubleshoot manufacturing challenges and support deviation investigations

Requirements

• Ph.D. in biomedical, chemical, materials science, or related engineering field, or MS with 5-10 years industry experience
• 3-5 years industry experience developing medical devices or drug-device delivery systems
• Product and process design, development, verification, and validation experience
• Commercial scale manufacturing knowledge and hands-on lab experience
• Strong technical writing and data presentation skills
• Knowledge of FDA and ISO standards for medical device development
• Experience with pre-filled syringes, wearable devices, or electro-mechanical pump systems preferred