Scientist - Bioanalysis & Biomarkers- LCMS

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