• Responsible for the planning, organizing, and ongoing operations of the sample preparation department, including supply, staff and space needs.
• Coordinates department activities based on client study designs and expected completion timelines.
• Directly supervises the sample preparation staff, including training, planning, assigning and directing work, evaluating performance, rewarding and disciplining employees, addressing complaints and resolving problems. Participates in hiring and termination process.
• Trains technicians in sample preparation, formulation, and extraction of prepared samples in support of in vitro and in vivo biocompatibility assays, pharmacology and toxicology procedures. Also, trains technicians in general laboratory procedures, study article receipt, proper documentation, daily department processes, maintenance duties, and safety precautions. Coordinates training schedule and maintains employee training records.
• Acts as technical lead for sample preparation activities, including medical device preparation, test specifications, raw materials, and protocol generation. May advise clients on routine technical issues.
• Maintains accurate records and inventories related to department supplies and related equipment and coordinates with purchasing to ensure adequate inventory and supply levels. Controls expenses by submitting budget information and scheduling expenditures.
• Maintains deviation and other appropriate departmental metrics. Reviews and assists technicians with corrective actions and other deviation-related documentation.
• Reviews, updates and develops departmental SOPs and other technical documents to reflect current policies and practices and to ensure compliance with standards and regulations.
• Other duties and responsibilities as assigned.