Microbiology Department Project Lead

📋 Description

• Serve as the technical lead for the Microbiology department, providing scientific oversight and
• Lead and manage microbiology-related projects from initiation through implementation, ensuring
• Own and coordinate microbiology change controls, assessing technical impact, defining
• Author, review, approve, and implement microbiology procedures, specifications, protocols, and
• Lead method qualification, verification, validation, and transfer activities for microbiological
• Provide technical review and approval of investigations, deviations, laboratory events, and CAPAs

🎯 Requirements

• Bachelor’s degree in Science/Engineering/Business Management or equivalent technical work experience
• 5+ years of relevant Quality experience in a GMP pharmaceutical, biologics, and/or medical device
• Strong understanding of cGxPs, regulatory inspections, regulatory documents, global regulations
• Experience in Project Management and leading cross-functional project teams with technical
• Strong oral and written communication, interpersonal, time management, influence, and
• Proficient in the use of standard software applications including Office 365

🎁 Benefits

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k)
• short-term incentive programs