Immunoassay Group Lead
We are a gene therapy company changing lives with every genetic advancement.
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that cure genetic diseases has never wavered.
As the only end-to-end gene therapy company in the industry, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly owned, independently operated subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy Platform. Our global headquarters are in Research Triangle Park, North Carolina, a thriving biotechnology hub, and we maintain additional research and development operations in Scotland and France and gene therapy manufacturing in Spain.
We have an opportunity for an Immunoassay Group Lead to join the AskBio team in our Research Triangle Park (Durham), NC location and be part of our continued success!
About the role
We are seeking a highly motivated Senior Scientist to join our immunology team and lead development, qualification and GxP validation of immunoassays supporting preclinical and clinical studies for AskBio’s pipeline of AAV-based gene therapy programs. The successful candidate will have prior supervisory experience in designing, executing and troubleshooting cell-based and/or ligand-based immunological assays. The ideal candidate for this position is expected to be an effective team manager and mentor members of the immunoassay team to ensure on-time delivery and interpretation of results and drive technical excellence within the Immunology team.
Responsibilities & Accountabilities
Serve as SME and/or a lead scientist for development, qualification and validation of cell-based methods such as neutralizing antibody (NAb) assays, T-cell responses by ELISpot, in vitro bioassays; and/or ligand-based methods such as binding antibody (BAb) assays and pharmacokinetic (PK) assays.
- Manage performance of all the assays mentioned above according to GxP guidelines and help in building GxP immunoassay lab through drafting of SOPs and lab protocols
- Coordinate maintenance of inventories for critical reagents and lab supplies to forecast future needs based on proposed project requirements
- Supervise a team of scientists and research associates in preparation of worksheets, plans and reports for the immune assays
- Manage out-sourced immunoassays by being point of contact for CROs and clinical operations
- Guide program specific stakeholders in applying immunoassay results to making strategic decisions
- Lead on-boarding of new platforms and capabilities in immunology labs
- Assist with the preparation and review of protocols, clinical study reports and bioanalytical sections of plans, INDs, abstracts, manuscripts and technical reports
- Collaborate with key translational, preclinical, clinical, regulatory and product development colleagues to develop and qualify/validate specific methods to address preclinical and clinical needs
- Work closely with other lab-based personnel within the translational medicine and product development groups to ensure optimal laboratory environment (collaboration, culture, safety, etc. in adherence with the AskBio’s values)
- Demonstrate initiative, teamwork, collaboration and technical expertise as an independent and team player
- Follow best practices for data integrity complying with organization and company standard operating procedures in a timely fashion
- PhD with minimum of 6 years, or MS with minimum of 8 years, or BS with minimum of 12 years relevant experience is required, preferably performing large molecule bioanalysis in biotech companies or in CROs
- In-depth understanding of immunology, drug immunogenicity, and methodology of assay development
- Hands-on experience in development, qualification and validation of immunoassays in the context of drug development
- Prior experience in R&D of biologics required; hands-on experience in gene therapy a plus
- Prior experience in supervisory role for development, GxP validations and sample analysis supporting clinical studies in at least two of the following areas:
- Cell-based assays: NAb and T-cell response ELISpot
- Ligand-based assays: BAb, PK and biomarker testing using standard ELISA, Mesoscale Discovery, Simoa, and/or Luminex platforms
- Proficiency using instruments and their corresponding software for plate readers (Biotek cytation or similar), plate washers, fluorescent microscopes, and ELISpot analyzers (CTL S6 Ultimate or similar) is a must
- Prior experience with statistical analysis tools such as Graphpad Prism and JMP is preferred
- Prior experience drafting SOPs for methods validations, instrument qualifications and general GxP compliance is preferred
- Must be able to work in BSL2 and BSL2+ environments
- Must be self-motivated, organized and capable of working independently, as well as a team manager and/ or player
- Must possess strong oral and written communication skills. Excellent interpersonal skills with the ability to interact effectively with teams, internally and externally
Live an AskLife™
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