Job Title

Position Summary for Lab Coordinator: As a Lab Coordinator, you are responsible for supporting the Senior Manager Laboratory Operations with coordinating and continuously improving lab activities, operations, supply chain and performing supportive administrative duties as needed. Duties and Responsibilities: Sample Accession: Receiving, storage and tracking of study samples. Supply Chain: Responsible for ordering, follow-up and maintenance of general lab supply inventories and lab storage room. Database Maintenance: Such as, but not limited to, study samples, reference standards, pipette verification/calibration and staff scheduling. Study Documentation Review: Including verification of good documentation practices and QC review of logbooks and data. Preparation of reagents, stock solutions, mobile phase, reference standard weighing and perform sample extractions. The ability to work towards deadlines due to the time pressured nature of some studies. The ability to utilize word processing, databases, spreadsheets, and specialized software on personal computers. Flexibility in working outside of contracted hours and weekends on a rotational basis. Communicate discrepancies to appropriate personnel and assist with problem solving. Coordinate and support lab activities and operations and any other supporting duties as assigned on an as needed basis. In addition to General Responsibilities, the following are additional responsibilities in regard to the conduct of GLP and Non-GLP studies: Work 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 Position Summary for 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. Duties and Responsibilities: 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. Qualifications: B.Sc. or College Diploma in Analytical chemistry or related subject Minimum of 1-3 years of related experience College Diploma in a related science/life science discipline Experience may be substituted with education Working knowledge of computers Customer service skills including attention to detail, accuracy, confidentiality, and communication skills Experience working under GxPs Must be able to lift up to 50 lbs., bend, reach, climb stairs and stand for extended periods of time