Scientist, Regulated Bioanalysis

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 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 also be involved in the development and execution of total antibody (Ab) assays using ELISA or ECLIA methodologies. The incumbent will be tasked with the development, validation and implementation of ligand-binding and/or cell-based assays to detect the presence of anti-AAV antibodies. S/he will work under supervision of a Senior 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 including CLIA certified laboratories.

The successful candidate 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.

Responsibilities

• Development and implementation of generic and novel neutralization assays and total Ab assays in support of pre-clinical and clinical studies.
• Analyze scientific data, write reports and technical documents to support assay development, pre-validation, and transfer to internal validation teams and external partners as appropriate. Participate in assay validation as required.
• Present data at internal team meetings.
• Ensure work is done in a compliant manner according to SOPs, GLP and GCP-like guidelines.
• Stay informed of new scientific/technology development by participating in external scientific conferences and through regular scientific literature review.

Education and Experience Requirements

• Ph.D. with 2+ years or M.S with 5+ years of experience or B.S with 8-10+ years
• Degree in Immunology, Cell Biology, or other relevant areas of Biology.
• Experience with cell-based assays and ELISAs is a must.
• 2+ years of bioanalytical experience in regulated bioanalysis or discovery bioanalysis is a must.

Key Skills, Abilities, and Competencies

• Lab-based position. Experience with gene therapy and innovative thinking a plus.
• Advanced technical lab skills. Hands-on experience with bioanalytical and immunogenicity assays.
• Expertise in development of immunoassays, in particular total Ab assays and cell-based neutralizing Ab 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-like environment.
• Ability to understand, present and interpret data and grow with a project. Strong skills in synthesizing research findings.
• Normally receives no instructions on routine work. Minimal instructions on new assignments.

Spark takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $100,200 to $150,400.

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.