As a member of the Neutralization Assay Team, the scientist will conduct cell-based and other types of neutralization assays in support of pre-clinical and clinical studies for gene therapy programs in a regulated environment. The incumbent will be tasked with the development, validation and implementation of ligand-binding and cell-based assays to detect the presence of neutralizing antibodies. S/he will work under supervision of the team lead.
The successful candidate will perform data analysis and interpretation and author reports and protocols. S/he will be responsible for the transfer of data to inter-departmental partners and for facilitating communication and technology transfer between Spark and CROs.
The successful candidate will ensure that all work is done in a manner compliant with relevant SOP guidelines and regulatory expectations. With guidance, S/he will advance bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assays for regulated support. In addition, the candidate will work closely with the team lead to explore and develop novel next generation neutralizing antibody assays.
- Development, validation, and implementation of generic and novel neutralization assays in support of pre-clinical and clinical studies.
- Analyze scientific data, write reports and technical documents to support assay development, validation, and transfer to external partners as appropriate. Present data at internal team meetings
- Ensure work is done in a compliant manner according to SOPs and GLP guidelines.
- Stay informed of new scientific/technology development by participating in external scientific conferences and through regular scientific literature review.
Education and Experience Requirements
•Typically has a PhD in a scientific discipline and related experience. May also have a Bachelor’s or Master’s degree and significant related experience- generally 8+ years. Individual experience may vary based on skillset and expertise.
• Immunology, Cell Biology or other relevant areas of Biology or Bioanalytical Science
• Experience with cell-based assays is a must
Key Skills, Abilities, and Competencies
• A strong background in immunology or related field such as cell biology
• Lab-based position. Experience with gene therapy a plus
• Advanced technical lab skills. Hands-on experience with bioanalytical and immunogenicity assays
• Expertise in development and validation of immunoassays, in particular cell-based neutralizing antibody assays directed at viral capsids and transgene proteins. Experience with cell-based potency assays may be considered a transferable skill.
• Attention to detail, precision in work, mastery of aseptic techniques and cell-culture methods
• Experience working in a GLP and GCP environment
• Ability to understand, present and interpret data and grow with a project. Intermediate skills in synthesizing research findings.
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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