Pharma Jobs in Cobourg, ON

Job Description

Job Description

Pharma Medica Research is a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are currently searching for a Sr. Lab Analyst to join our team!

The Sr. Bioanalytical Analyst carries out bioanalytical analyst functions primarily in support of bioanalytical drug testing and analysis. This position reports to the Team Leader / Bioanalytical Lab and / or designate.

Duties and Responsibilities

Duties include, but are not necessarily limited to :

• Ensure calibration and maintenance, as well as, operation of all principle laboratory equipment- including HPLC, LC / MS, LC-MS / MS (if not experienced, must agree to be trained on the equipment), balances, pH meters, pipettes, freezers, water system, equipment for sample extraction, evaporation and fume hoods.
• Upon being assigned a clinical or pre-clinical study, must ensure all supplies for the study have been ordered, ensure pools and randomization charts are prepared prior to the first day of analysis. Ensure that all technicians involved in the analysis are trained in the analytical method.
• Supervise technicians during sample preparation including approval of documentation.
• Write and maintain updated Standard Operating Procedures (SOPs) as required.
• Perform method validations including the writing of the method report.
• Liaise with Principal Bioanalytical Investigator, Quality Control to ensure proper and timely completion of analytical assays.
• Maintains up to date records and logs, signed and witnessed as necessary according to laboratory GLP / SOPs and regulatory requirements.
• Conduct laboratory activities in compliance with PMRI' s SOPs and Good Laboratory Practices (GLPs).
• Attend SOP and GLP training programs as required. Provide suggestions and / or recommendations on how to improve operations of the laboratory, structure and content of SOPs and compliance with GLP requirements.
• Assist, advise and play a key role in the development and validation of bioanalytical methods in accordance with FDA, TPP and other international regulatory requirements.
• Other duties as required.

Qualifications;

If interested, apply today!