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

Amador Bioscience
Pleasanton, CA
Closing date
Nov 26, 2022

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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.
* 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 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 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 regulations
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