Drug Products Supervisor
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.
- 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
- 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)