
Senior Scientist LCMS
2 weeks ago
· 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.