The Research Associate will report to the Neutralization Assay Team Lead. He/She will conduct routine sample analysis using well-established cell-based neutralizing antibody (NAb) assays to support patient screening and selection across programs in a GLP/GCP compliant manner and maintain accurate, timely and detailed record of work. The candidate will also provide preclinical support for GLP studies. The incumbent will also evaluate post-infusion NAb responses in patients and contribute to assay modifications and assay qualifications related to continued improvement of existing assays and standard operating procedures. The candidate will keep track of long-term assay performance and data trends and proactively trouble-shoot assay related issues. He/She will work with team members and ensure adequate materials and reagent supply and qualify new reagent lots as needed. He/She will participate in exploratory evaluations of new NAb assay technologies and contribute NAb assay data to help understand correlation with total antibodies. He/She will interface with clinical operations, sample management and LIMS group for sample shipment schedules, sample handling and chain-of-custody related workflow and author SOPS and conduct periodic reviews of documents.
Experimental design, lab work and data analysis
Regulated and non-regulated bioanalysis related documentation
Miscellaneous bioanalytical department and company related tasks and trainings
Education and Experience Requirements
BA/BS in biological sciences required. Master’s degree preferred. Generally, has at least 3-5 years of relevant experience
Key Skills, Abilities, and Competencies
Other Job Requirements
- Cell-based assay experience is a must.
- Ability to perform tasks independently. Ability to learn new techniques and perform multiple tasks.
- Be self-motivated, adaptable and have a positive attitude especially when dealing with challenges.
- Excellent organizational, communication and collaboration skills
- Work is performed without appreciable direction.
- Exercises considerable latitude in determining objectives and approaches to assignment
- Keep accurate records, comply with Good Documentation Practice, follow instructions, and comply with company policies. Familiarity with Electronic Lab Notebook (ELN) and Lab Information Management Systems (LIMS).
- Attendance at one relevant conference per year and participation in internal and cross-functional team meetings are expected.
- On site lab benchwork is expected.
- 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.
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.
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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.
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