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Primary Duties
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The Bioanalytical Scientist will be part of the Translational Bioanalytics Group, supporting multiple non-clinical and clinical studies in a regulated environment for advancing gene therapy programs across all therapeutic areas. The Bioanalytical Scientist will conduct various bioanalytical assays, such as immunoassay, anti-drug antibody, enzymatic activity, and biomarker assays under the guidance and supervision of the manager.
The Bioanalytical Scientist is responsible for:
- Plan and perform optimization or development of new bioanalytical assays; primarily assays for protein levels or activity
- Perform and/or provide oversight of method qualification and validation of bioanalytical assays following regulatory guidelines
- Conduct and/or provide oversight of non-clinical and clinical sample analysis following standard operating procedures (SOPs) and regulatory guidelines
- Perform data analysis using basic and advanced software
- Maintain accurate, timely, and detailed records of all experimental work in accordance with Good Documentation Practices (GDP) and SOPs
- Collaborate with and provide training to junior scientists
- Author and review technical documents, protocols, reports, and SOPs
- Assist in equipment maintenance and calibration in accordance with GDP and SOPs
- Reagent sourcing, receipt, storage, inventory, preparation, and qualification
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Responsibilities
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Hands-on laboratory work supporting development, optimization, qualification/validation of bioanalytical assays
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Hands-on laboratory work supporting sample testing and reporting
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Maintain and review GDP documentation for all experimental work
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Prepare and review technical documents, protocols, reports, and SOPs
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Train and mentor junior scientists and associates
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Perform and/or monitor equipment maintenance/calibration
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Reagent ordering, receipt, storage, inventory, preparation, and qualification
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Maintain updated safety, compliance, and SOP training
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Education and Experience Requirements
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- PhD, BS or MS in relevant scientific discipline (molecular biology, biochemistry, immunology, cell biology, etc.)
- Minimum of 3 years bioanalytical experience, preferably with immunoassay, anti-drug antibody, enzymatic, and/or biomarker assays
- Understanding of GLP and regulatory guidance for bioanalytical assay validation and sample testing
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Key Skills, Abilities, and Competencies
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- Hands-on experience in assay development, optimization, qualification/validation of bioanalytical assays is required; experience obtained in a pharmaceutical environment is preferred
- Understanding of GDP and GLP is required
- Strong organizational, communication, and writing skills
- Ability work independently as well as possess self‑motivation, adaptability, and a positive attitude
- Detail oriented with a desire to produce high-quality results
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