Sr. Scientist/Principal Scientist-Bioanalysis & Biomarkers-LBA

Company: AMADOR BIOSCIENCE INC
Location: Pleasanton
Posted on: March 18, 2023

Job Description:

PurposeAmador 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 bioanalytical methods for biological sample testing and data reporting.
• Present/interpret data internally and/or externally as needed.
• Lead Method development efforts for ligand binding assays (ELISA, MSD) for PK, ADA, and biomarker readouts.
• Participate in interactions with clients and ensure overall customer satisfaction.
• Serve as the Primary Investigator (PI) for client studies from study design to scheduling, conducting, and reporting, as required.
• 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 assignedQualifications 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 6 + years of relevant experience in a CRO or drug-development environment.
  • Ability to work independently and have good attention to details.
  • Good knowledge GLP/GCLP regulations
  • Ability to achieve objectives/timelines through collaborative efforts with coworkers, managers, and clients.
  • Must be goal-oriented, quality-conscientious, and client-focused.
  • Responsible to achieve objectives/timelines through collaborative efforts with coworkers, managers, and clients.
  • Effective written and verbal communication skills.
  • Supervisory experience in both project and people management is a plus.
  • Experienced with Ligand Binding Assay (ELISA, MSD) and/or Cell-Based Assay method development and validation for PK, ADA, and/or biomarker analysis.Preferred Skills
    • Proficient in MS Office
    • Watson LIMS
    • Strong knowledge of GLP/GCLP regulationsSalary ranges depends on experience- From $130,000 to $180,000Job Type: Full-time

Keywords: AMADOR BIOSCIENCE INC, Pleasanton , Sr. Scientist/Principal Scientist-Bioanalysis & Biomarkers-LBA, Other , Pleasanton, California