Manager Microbiology

This position is primarily responsible for the management of supervisors and their teams of microbiologists whose activities consist of laboratory testing of in-process, release and stability samples for commercial drug products, including communication of lab testing completion dates to internal customers and oversight of lab investigations.

Manage teams consisting of supervisors, team leaders and microbiologists that are responsible for testing in-process, release and stability samples for commercial drug products. Approve purchases of lab consumables, supplies and capital expenditures and ensure overall spending is at or below budget.

Responsibilities

• Ensure testing is completed on or before assigned due date
• Communicate material issues or testing delays to the appropriate internal customer(s)
• Facilitate timely investigations of out-of-specification and out-of-trend data
• Assist in determining root causes and appropriate CAPAs
• Responsible for managing team's performance and applicable quality metrics and provide recommendations for improvement
• Monitor release and stability results for developing trends
• Perform critical review and approval of new/revised lab documentation such as SOPs, Training Modules, methods, specifications, and investigation protocols/reports
• Perform critical review and approval of method transfer protocols/reports
• Evaluate proper staffing and equipment needs
• Manage personnel including interviewing, hiring, performance reviews, disciplinary action, goals/objectives, rewards, coaching, training, etc.
• Assess and document employees' performance appropriately to ensure ongoing integrity of the testing results and help to ensure the quality of the site's drug products

Education/Qualifications

• Bachelor's degree in Microbiology and 10+ years of laboratory experience or a Master's degree in Microbiology with 8+ years of laboratory experience preferably within a pharmaceutical or manufacturing environment
• Knowledge of cGMP and other regulatory requirements
• Expert for QC microbiology including aseptic techniques
• Strong troubleshooting and investigation skills
• Expert on GMP, USP/NF and ICH guidelines
• Ability to define problems, collect data, establish facts and draw conclusions
• Ability to work on interdisciplinary teams
• Ability to wear PPE, gown up for microbiology lab testing area.

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