Analytical Team Leader | ClinLab Staffing
  • Pre-clinical/Life Sciences
  • Durham, NC
  • Applications have closed

Full-time, Permanent
· Supervise, mentor, train and develop junior scientists
· Lead, review and trend laboratory investigations from aberrant data, system suitability failures, method/protocol deviations, and OOS/OOT results, and implement CAPA for such occurrences
· Author validation and transfer protocols, instrument qualification protocols, analytical methods and reports including method development, transfer and validation, SOPs, etc.
· Review laboratory notebooks, data packs, and reports as directed
· Maintain a GMP-compliant analytical laboratory and safe working environment
· Maintain laboratory equipment, including calibration scheduling and basic maintenance programs

Required Qualifications and Skills:
· B.S., or M.S., with focus in chemistry
· 6-8 years’ experience in a GMP laboratory setting
· Experience leading a team of scientists a plus
· Experience with HPLC analysis, validation and troubleshooting required, method development experience strongly preferred
· Highly proficient in using Empower CDS
· Highly proficient in diagnosing and troubleshooting HPLC methods and instrumentation issues
· Experience in leading laboratory investigations, addressing OOS and OOT results
· Ability to interact with clients and contractors a plus
· Speaks, writes, listens and presents information in a logical and articulate manner appropriate for the audience
· Proficient in MS Office (Word, Excel, Outlook) and AdobePro