Manufacturing Scientist II

Manufacturing Scientist II provides technical support for sterile drug product manufacturing operations including filling, freeze-drying, and packaging. Develops and validates scientific methods for controlling materials and processes across multiple project stages, from pre-clinical through post-marketing.

Responsibilities

• Author and maintain standard operating procedures, batch records, protocols, and change controls in quality systems
• Lead cross-functional investigation teams for corrective and preventive action closure
• Evaluate manufacturing process design and contribute to problem-solving solutions
• Manage project timelines, deliverables, and coordinate with Quality, Operations, Engineering, and Validation teams
• Present technical recommendations and guide documentation strategies for new methodologies

Requirements

• Bachelor of Science in science or STEM discipline preferred
• 2-4 years scientific experience, preferably pharmaceutical industry
• Strong knowledge of Good Manufacturing Practices and compliance standards
• Technical writing experience
• Ability to work independently and lead cross-functional teams
• Ability to lift 40 lbs and work in laboratory environment with PPE