Scientist

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. 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. Role and 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. 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 Qualifications and Education 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. Preferred Skills Proficient in MS Office Watson LIMS Strong knowledge of GLP/GCLP regulations Salary range is from $105,000 to 120,000