Description Responsibilities · Develop and validate bioanalytical method based on regulatory guideline. · Perform sample analysis, process and review data. · Write method report, validation report and SOPs. · Apply strong understanding of SOPs and GLP/GCP regulations as applicable to the work. · Maintain study documentation and laboratory records. · Communicate results to supervisor and sponsors. · Calibrate/operate/maintain scientific equipment. · Provide recommendations to improve assay quality and efficiency. · Act as a technical resource for troubleshooting of assays and instruments. · Maintain a clean and safe laboratory work environment. · Assists with any additional job responsibilities or tasks based on business or departmental needs, as assigned by management. Skills, Education & Qualifications · Bachelor’s degree with 10 years or Ph.D. with 5 of working experience in bioanalysis or analytical chemistry or an equivalent combination of education, training, and experience as deemed appropriate by management. · Extensive knowledge and hands-on experience in LCMS. · Familiar with ICH M10 guidance. · Experience of working under a quality environment such as GLP, GCP or GCLP. · Good interpersonal skills with internal and external stakeholders. · Ability to use computers and software including word, excel, power point etc Desirable if familiar with Sciex OS and Watson LIMs.
