Research Associate

The Research Associate 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 Research Associate will conduct various bioanalytical assays, such as immunoassay, anti-drug antibody, enzymatic assay, and biomarker, under the guidance and supervision of senior scientists and manager.

The Research Associate is responsible to:

• Participate in the optimization or development of new bioanalytical assays

• Perform experiments contributing to method qualification/validation of bioanalytical assays to support non-clinical and clinical studies, following regulatory guidelines

• Participate in testing of non-clinical and clinical study samples and prepare data summary files

• Author technical documents, protocols, reports, and standard operating procedures (SOPs)

• Maintain accurate, timely, and detailed records of all experimental work in accordance with Good Documentation Practices (GDP) and SOPs

• Perform equipment maintenance and calibrations in accordance with GDP and SOPs

• Participate in reagent ordering, receipt, storage, inventory, preparation, and qualification

Responsibilities

• Hands-on laboratory work to develop, optimize, qualify/validate assays
• Hands-on laboratory work to conduct sample testing and reporting
• Maintain GDP documentation for all experimental work
• Prepare technical documents, protocols, reports, and standard operating procedures
• Perform equipment maintenance/calibration along with documentation
• Reagent ordering, receipt, storage, inventory, and preparation along with documentation
• Maintain updated safety, compliance, and SOP training

Education and Experience Requirements

• Bachelor’s degree in biological sciences required

• Minimum of 3 years bioanalytical experience

Key Skills, Abilities, and Competencies

• Experience with relevant bioanalytical assays (immunoassays, anti-drug antibody, enzymatic assays, biomarkers) in a pharmaceutical and/or academic environment is preferred

• Understanding of GDP and GLP is required

• Strong organizational, communication, and writing skills

• Ability to learn new techniques and work independently after training as well as possess self motivation, adaptability, and a positive attitude

• Detail oriented with a desire to produce high-quality results

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.