Neutralization Assay Team, Innovation Lead

Primary Duties:

The incumbent will be a member of the regulated bioanalysis team within the Bioanalytics Sciences (BAS) function at Spark Therapeutics (Tx). Primary duties will involve serving as a subject matter expert for cell-based anti-AAV capsid neutralizing antibody (NAb) assays, leading the development of next-generation NAb assays and participating in assay transfers to the Bioanalytics validation team and CROs. The successful candidate will also lead the development of anti-transgene protein NAb assays and will participate in the evaluation of emerging NAb evasion technologies in partnership with Business Development, External Alliance, and other Spark teams. In addition, they will serve as a bioanalytical representative on multiple asset teams and help integrate team goals into BA workflow of other Leads. The candidate will come with a strong scientific background and experience in the bioanalysis of Biologics and AAV gene therapy products. They will also interface with the internal Companion Diagnostics (CDx) team in Translational Sciences to provide oversight and / or assist in technical aspects of assay transfer to CLIA-certified labs. They will work under supervision of the team Leader and will be the primary point of contact on NAb and total Ab assay related inquiries from cross-functional teams. The incumbent will drive innovation and growth in the neutralization assay team, assess the needs for CLIA capabilities at Spark Tx and build as needed.

Responsibilities:

• Bench-level work is required at least 50-60% of the time.
• Manage activities of bench-level scientist(s)
• Develop next-generation cell-based NAb assays and Ligand binding assays using ELISA and/or ECLIA methodologies and establish appropriate methods for patient screening and exclusion.
• Lead the assay transfer of total Ab and cell-based NAb assays to assay validation teams and external CRO partners including CLIA-certified labs.
• Interface with the Translational Science team’s CDx Lead to support the transfer of internal laboratory developed tests to CLIA-certified labs.
• Interface with project teams as needed to serve as the bioanalytical representative for programs in the portfolio.

Education and Experience:

• Ph.D. with 5+ or Masters with 6+years of experience.
• Degree in Immunology, Cell Biology, or other relevant areas of Biology.
• Knowledge of AAV Gene Therapy.
• Experience with cell-based assays and ELISAs/MSD is a must.
• Bioanalytical experience in regulated and/or discovery bioanalysis including ADA and NAb assays.
• Hands-on experience developing and validating reporter-based, and ligand-binding NAb assays. NAb assay development in biologics may be a transferable skill.
• Hands-on experience in immunogenicity (ADA) assays.
• Experience with CLIA-certified assays desired.

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.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.

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.

Learn more about Spark Therapeutics and view other openings.