Process Development Principal Scientist

Responsibilities

• Serve as the lead scientific and technical expert within the department
• Develop novel experimental strategies and innovative solutions to complex technical problems
• Lead PD-related project management including planning, implementation, and monitoring
• Manage contractors, vendors, and cross-functional project teams
• Collaborate with manufacturing, engineering, quality assurance, and validation to resolve technical issues
• Apply Lean Six Sigma and continuous improvement methodologies to projects
• Ensure strict adherence to cGMP, GLP, and regulatory requirements
• Coach, mentor, and motivate colleagues providing scientific and career guidance

Requirements

• PhD / PharmD / MD with 2+ years of scientific or engineering experience
• Master’s degree with 5+ years of scientific or engineering experience
• Bachelor’s degree with 7+ years of scientific or engineering experience
• Working knowledge of pharmaceutical/biotech processes and regulated documentation
• Expertise with specialized laboratory equipment and scientific software
• Strong analytical problem-solving and technical writing skills

Preferred Qualifications

• Demonstrated leadership in scientific project management within biotech environments
• Experience supporting inspection-related project management activities
• Proven ability to develop business cases including technical and financial components
• Strong negotiation, facilitation, and vendor management skills

Benefits

• 6-month contract with possible extension
• Administrative shift