Job Description

Job Description

Job Description

Salary: $138,000.00 - $148,000.00

Summary
We are seeking a highly motivated and experienced scientist to join our Bioanalytical team in Pre-clinical Department. This Senior Scientist II position will play a role in the bioanalytical LC-MS/MS method development, validation and sample analysis for the quantification or qualification drugs and metabolites in biological matrices under GLP and non-GLP guidelines to support nonclinical and clinical studies. This position is also responsible for communication/presentation of bioanalytical results with relevant team members.

Responsibilities

• Develop and validate LC-MS/MS methods for the quantitation of drugs/metabolites in biological matrices under GLP and non-GLP guidelines to support nonclinical and clinical studies at different developmental stages.
• Serve as study director/principal investigator with responsibility for study binder review.
• Lead and/or supervise bioanalytical activities.
• Maintain, operate, and troubleshoot API5500 LC-MS/MS instruments and other analytical equipment.
• Study and recommend new techniques in sample purification, analysis, and automation.
• Write and revise departmental SOPs, validation and analytical protocols and reports.
• Ensure adherence to protocols, SOPs and GLP guidelines.
• Ensure data integrity and compliance with applicable regulatory guidelines.
• Analyze technical data to draw conclusions.
• Assist in the preparation of any regulatory submissions.
• May provide training to new and less experienced departmental staff.
• Maintain research records and lab notebooks in a concise, legible and complete manner.

Preferred Requirements

• B.S. or M.S. in Analytical Chemistry or other related disciplines.
• At least 10 years of CRO or relevant industrial hands-on experience in bioanalytical method development/validation and sample analysis using LC-MS/MS techniques in a regulated bioanalytical environment.
• In-depth knowledge of LC-MS/MS techniques and sample preparation are a must.
• Prior experience serving as a study director/principal investigator. This experience includes development of study protocols, SOPs, validation and analytical reports; preparation and/or review of study binders ensuring compliance.
• Proficiency with software such as Sciex Analyst, Microsoft Word, Excel, and PowerPoint as well as online quality management and document handling systems.
• Experience with liquid handling programming.
• Strong communication skills, as well as the ability to be a team player.
  

Arthrosi Therapeutics is an equal opportunity employer. All applicants will be considered foremployment without attention to the following: race, color, sex, sexual orientation, gender,gender identity, religion, national origin, citizenship and/or immigration status, pregnancy,genetic information including family medical history, physical or mental disability, child orspousal support withholding, military or veteran status, medical condition, marital status,
AIDS/HIV, natural hair styles, political activities or affiliations, domestic violence, assault, orstalking victim status, application for or enrollment in Medi-Cal, lawful conduct occurringduring nonworking hours away from the employers premises, credit report or creditinformation, prior non-conviction arrest record, and any other protected class, in accordancewith applicable federal, state, and local laws.

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