Scientist III

Responsibilities

• Maintain and manage inventory of GLP and Clinical bioanalytical samples and critical reagents
• Utilize one or more Laboratory Information Management Systems (LIMS) to track sample chain of custody from receipt through disposal/shipping
• Coordinate domestic and international sample or reagent shipments off-site.
• Perform aliquoting of clinical samples either through manual pipetting or lab automation.
• Participate in CTU maintenance and alarm handling
• Retrieve and provide materials to bioanalytical staff on site
• Communicate with clinical sites, central lab, or on-site collection areas for receipt of materials and discrepancy resolution.

Qualifications

• Education - Bachelor’s Degree in the sciences or related field
• Experience - Minimum of 2 years in the pharmaceutical or related industry

Required Skills and Experience

• Strong knowledge in GxP and compliance guidelines, preferably in a bioanalytical laboratory environment
• Experience managing sample chain of custody within a GLP/GMP lab
• Utilize electronic laboratory notebooks for laboratory documentation
• Operate within the confines of departmental SOPs and regulatory guidance’s
• Capable of working independently under moderate supervision
• Possesses good verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators

Desired Skills and Experience

• Computer literacy knowledge (e.g. MS Office) and experience using a laboratory LIMS system (e.g. Watson LIMS, Labware LIMS, etc)

• May Author SOPs associated with sample or reagent management processes.