Scientist - Bioanalysis & Biomarkers- LCMS

$105,000 - $120,000/Yr

Amador Bioscience - Pleasanton, CA

Full-time - Mid Level

Pleasanton, CA

Professional, Scientific, and Technical Services

About the position

Amador Bioscience (AmadorBio) is a Translational & Clinical Pharmacology CRO providing global-standard services in quantitative clinical pharmacology, GLP/GCLP bioanalysis, clinical research, and regulatory filing to leading biopharmaceutical companies. Our clients include multinational pharmaceuticals and mid- and small-size biotech companies. Amador Laboratory Services Division specializes in bioanalysis (PK/PD/ADA), biomarkers, assay development & validation, and sample analysis. The team has successfully supported multiple non-GLP, GLP (nonclinical) and GCLP (clinical) projects. To meet the needs of business growth, we are looking for a highly motivated, experienced scientist/senior scientist to join our passionate team to partner with our clients for success. The successful candidate will be responsible for providing bioanalytical supports for both pre-clinical and clinical projects and will report to the Laboratory Head.

Responsibilities

• Develop, validate, conduct, and troubleshoot UHPLC and LC-MS analytical methods to quantitate large molecules and metabolites in biological fluids
• Present/interpret data internally and/or externally as needed
• Participate in interactions with clients and ensure overall customer satisfaction
• Interact with QA to ensure all audit findings are addressed in a timely fashion
• Author and/or review key regulatory documents, laboratory data, and technical reports
• Assist with the oversight of the laboratory and mentor junior staff
• Assist in establishing and improving all policies, procedures and required SOP documentation
• Understand and adhere to corporate standards regarding code of conduct, safety, and GLP/GCP/GDP compliance
• Ensure and review lab maintenance activities and maintain a clean and safe lab environment
• Develop, write, and review protocols and SOPs
• Participate in regulatory compliance activities
• Perform all other related duties as assigned

Requirements

• Ph.D., Master's, or Bachelor's degree in biology, immunology, chemistry, pharmacology, or other related scientific fields required
• Requires a minimum 0-9 years of relevant experience in a CRO or drug-development environment
• Ability to work independently and have good attention to details
• Good knowledge of regulated bioanalysis. GLP/GCLP experience preferred
• Ability to achieve objectives/timelines through collaborative efforts with coworkers, managers, and clients
• Must be goal-oriented, quality-conscientious, and client-focused
• Effective written and verbal communication skills
• Experienced with LCMS or tandem Mass-Spec method development and validation for PK and/or biomarker analysis

Nice-to-haves

• Proficient in MS Office
• Watson LIMS
• Strong knowledge of GLP/GCLP regulations