Bioanalytical Scientist

Primary Duties

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

Responsibilities

% of Time

Job Function and Description

80%

Hands-on laboratory work supporting development, optimization, qualification/validation of bioanalytical assays

Hands-on laboratory work supporting sample testing and reporting

Maintain and review GDP documentation for all experimental work

Prepare and review technical documents, protocols, reports, and SOPs

Train and mentor junior scientists and associates

20%

Perform and/or monitor equipment maintenance/calibration

Reagent ordering, receipt, storage, inventory, preparation, and qualification

Maintain updated safety, compliance, and SOP training

Education and Experience Requirements

• PhD, BS or MS in relevant scientific discipline (molecular biology, biochemistry, immunology, cellbiology, 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

Key Skills, Abilities, and Competencies

• 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

#LI-JW1

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

Nearest Major Market: Philadelphia

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.

We don't follow footsteps. We create the path.