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