Drug Products Supervisor
Lannett
 Seymour, IN

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)
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