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Senior Scientist
2 months ago
Amador Bioscience Inc. is a premier provider of Translational & Clinical Pharmacology services, specializing in quantitative clinical pharmacology, bioanalytical services, and regulatory submissions for leading biopharmaceutical organizations. Our clientele encompasses large pharmaceutical firms as well as emerging biotech companies.
The Laboratory Services Division at Amador focuses on bioanalytical services including pharmacokinetics, pharmacodynamics, anti-drug antibody assessments, and assay development and validation. Our dedicated team has effectively supported numerous projects across non-GLP, GLP (nonclinical), and GCLP (clinical) settings. To support our expanding operations, we are seeking a driven and skilled scientist or senior scientist to contribute to our mission of client success.
Key Responsibilities
- Design, validate, execute, and troubleshoot analytical methods using UHPLC and LC-MS for quantifying large biomolecules and their metabolites in biological samples.
- Communicate and interpret analytical results to both internal teams and external stakeholders as required.
- Engage with clients to ensure satisfaction and address any inquiries.
- Collaborate with Quality Assurance to promptly resolve any audit-related issues.
- Draft and review essential regulatory documents, laboratory findings, and technical reports.
- Oversee laboratory operations and provide mentorship to junior scientists.
- Contribute to the development and enhancement of laboratory policies, procedures, and standard operating protocols.
- Adhere to corporate standards concerning conduct, safety, and compliance with GLP/GCP/GDP regulations.
- Ensure laboratory maintenance activities are conducted and maintain a safe and organized work environment.
- Draft, review, and refine protocols and SOPs.
- Participate in activities related to regulatory compliance.
- Perform additional duties as assigned.
Qualifications and Educational Background
- Ph.D., Master's, or Bachelor's degree in biology, immunology, chemistry, pharmacology, or related scientific disciplines.
- A minimum of 0-9 years of relevant experience in a contract research organization or drug development environment.
- Ability to work autonomously with a keen attention to detail.
- Strong understanding of regulated bioanalysis; experience with GLP/GCLP is preferred.
- Capability to meet objectives and timelines through effective collaboration with colleagues, management, and clients.
- Goal-oriented, quality-focused, and client-centric approach.
- Excellent written and verbal communication skills.
- Experience with LC-MS or tandem mass spectrometry method development and validation for pharmacokinetic and/or biomarker analysis.
Preferred Competencies
- Proficient in Microsoft Office Suite.
- Familiarity with Watson LIMS.
- Strong understanding of GLP/GCLP regulations.
Compensation
The salary range for this position is between $105,000 and $120,000.
