Immunogenicity Team Lead
Date: Apr 7, 2021
Location: Philadelphia, PA, US
Company: Spark Therapeutics
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.
Primary Duties
|
|
As a member of the Bioanalytics Team, the Immunogenicity Team Lead will oversee the execution, quality and timelines of immunogenicity assays in support of pre-clinical and clinical studies for gene therapy programs in a regulated environment. The incumbent will manage a team tasked with the development, validation and implementation of ligand-binding and cell-based assays to detect the presence of anti-product binding and neutralizing antibodies. S/he will supervise the activities of junior staff members, guiding them in the design and interpretation of experiments. 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 interface with Spark project teams and ensure that all work is done in a manner compliant with relevant SOP guidelines and regulatory expectations. S/he will advance bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assays for regulated support. |
|
|
|
Responsibilities |
|
% of Time |
Job Function and Description
|
20 |
Manage immunoassay team to achieve business goals and objectives.
|
30 |
Oversee the development, validation and implementation of immunoassays in support of pre-clinical and clinical studies. |
30 |
Analyze scientific data, write and review reports, technical documents and presentations to support assay development, validation and transfer to external partners as appropriate. |
10 |
Provide work assignments to the team on a regular basis. Review and approve the work performed by other analysts. Ensure work is done in a compliant manner according to SOPs and GLP guidelines. |
10 |
Stay informed of new scientific/technology development by participating in external scientific conferences and through regular scientific literature review. |
|
|
Education and Experience Requirements |
|
|
|
Key Skills, Abilities, and Competencies |
|
|
Nearest Major Market: Philadelphia