- 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.
- Interacts 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 reviews lab maintenance activities and maintains 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
- Ph.
- 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.
- Proficient in MS Office
- Watson LIMS
- Strong knowledge of GLP/GCLP regulations
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Scientist - Bioanalysis & Biomarkers- LCMS - Pleasanton, United States - Amador Bioscience
Description
Purpose
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.
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.
Role and Responsibilities