Drug Products Supervisor

Job Summary

This position is primarily responsible for the supervision of the daily operations of a team of analysts 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 their Manager and the Lab Support Supervisor as well as conducting lab investigations.

Responsibilities

• Ensure testing is completed on or before assigned due date
• Communicate material issues or testing delays to the appropriate internal customer(s) (i.e. Manager, Lab Support Supervisor)
• Critically review raw data, chromatography, data sheets/LIMS, and protocols/reports for accuracy and completeness
• Conduct timely investigations of out-of-specification and out-of-trend data
• Determine root causes and appropriate CAPAs
• Responsible for supervising 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.
• 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

• BS Degree in Chemistry or related field
• Minimum of 5 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment
• Knowledge of cGMP, USP/NF, ICH, DEA, EU and FDA guidelines and regulations
• Competent in analytical methods and lab instrumentation (e.g. HPLC, GC, dissolution, wet chemistry)
• Excellent oral and written communication skills
• Strong organization, time management, leadership, troubleshooting and investigation skills
• Expertise in Microsoft Word and Excel
• Experience with software associated with a Quality Management System (QMS), a Laboratory Information Management System (LIMS), and a Chromatography Data System (CDS)