Scientist/Senior Scientist-Bioanalysis & Biomarkers (CA &MD)
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 bioanalytical methods for biological sample testing and data reporting. Present/interpret data internally and/or externally as needed.
- Serve as the primary contact for interaction with the client from study design to scheduling, conducting, and reporting. Ensure responsiveness to the client and overall customer satisfaction.
- 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.
- Perform all other related duties as assigned
Qualifications and Education Requirements
- Ph.D. or Master’s degree in biology, immunology, chemistry, pharmacology, or other related scientific fields required, including a minimum of 2-5 years' relevant experience.
- Supervisory experience in both project and people management is preferred.
- 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.
- Proficient in MS Office, SoftMax Pro, Watson LIMS
- Experience in Molecular Cell Biology or Immunology