Bioanalytical Chemist

Under the direction of the Departmental Manager, performs method validation and biostudy analysis tasks in order to generate analytical test results in compliance with all current applicable Standard Operating Procedures.

• Performs method validation and biostudy analysis tasks in accordance with SOPs.
• Has a good knowledge of analytical laboratory equipment’s common in the Bioanalytical Laboratory such as sample preparation equipment, general Laboratory equipment and LC-MS/MS.
• Conduct all work in a good team environment focusing on meeting project timelines.
• Provides assistance to plan and coordinate projects with responsibility to accommodate frequently changing priorities.
• Generates analytical test results in compliance with all current applicable Standard Operating Procedures.
• Generates method procedures, results, validation, re-validation and analytical reports for direct submission to regulatory authorities.
• Coordinates projects and work activities with Laboratory Management to meet established objectives.
• Shows innovation on an ongoing basis to assist management in solving problems related to any bioanalytical issues and laboratory processes.
• Provides assistance in troubleshooting and maintenance of laboratory equipment
• Assists in reviewing Standard Operating Procedures.
• Demonstrates excellent written and verbal communication skills.
• Performs the job in a cost-effective manner.
• Compiles and archives study/validation data.
• Performs the job according to an approved Protocols and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements.
• Works in a safe manner, complying with all relevant safety procedures and requirements.
• Exhibits good interpersonal skills, a professional attitude and motivation to produce consistently high quality work.
• Performs other related duties assigned by the management.

In addition to General Responsibilities, the following are additional responsibilities in regards to the conduct of GLP and Non-GLP studies:

• Generates analytical test results in compliance with all current SOPs, protocols, study plans and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements.
• Documents and communicates any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies).
• Records raw data promptly and accurately and in compliance with the OECD Principles of Good Laboratory Practice.
• Exercises health precautions to minimize risk to him/herself and to ensure the integrity of the study. Communicates to the Laboratory Management any relevant known health or medical condition so he/she can be excluded from operations that may affect the study.

• B.Sc. or College Diploma in Analytical chemistry or related subject
• Minimum of 1-3 years of related experience