Principal Scientist (Process Definition and Scale-Up)

The Principal Scientist will lead process development activities to scale up and define the processing space of oral solid pharmaceutical products, and will provide technical support to the commercial operations team.

Requirements

• 10+ years of experience in pharmaceutical product and process development, with a focus on oral solid dosage forms
• Expertise with common unit operations for blending, milling, granulation, compression, fluid bed coating, and encapsulation
• Understanding of formulation concepts and material properties of common excipients
• Experience in process development activities that support process validation, and familiarity with appropriate regulatory expectations and industry practices
• Experience with transfer of manufacturing processes into GMP environments and / or process transfer between different manufacturing sites
• Experience with principles of risk-based decision making and common tools for risk analysis
• Advanced laboratory and data analysis skills
• Excellent verbal and written communication skills
• Excellent time management skills, with an ability to prioritize and / or delegate tasks appropriately to meet deadlines
• Excellent leadership and collaboration skills
• Ability to function well in a high-paced and at times stressful environment

Benefits

• Over four weeks of paid time off annually
• Employer contributions to a retirement account after 90 days
• Various health plans with minimal employee contributions
• Basic life and long-term disability coverage
• Employee Assistance Program
• Pet insurance