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Scientist - Bioanalysis & Biomarkers- LCMS

4 months ago

Pleasanton, United States AMADOR BIOSCIENCE INC Full time
Job DescriptionJob 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. 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