Job: Bioanalytical and Bioassay Lead, AskBio, Durham, NC
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG acquired in 2020, is a fully integrated AAV gene therapy company dedicated to developing life-saving medicines that have the potential to cure genetic diseases. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular and metabolic disease indications with a clinical-stage pipeline that includes therapeutics for Pompe disease, Parkinson's disease and congestive heart failure, as well as out-licensed clinical indications for hemophilia and Duchenne muscular dystrophy. AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, UK, the company has generated hundreds of proprietary third-generation AAV capsids and promoters, several of which have entered clinical testing. Founded in 2001 and an early innovator in the gene therapy field, the company holds more than 850 patents in areas such as AAV production and chimeric and self-complementary capsids. Learn more at www.askbio.com.
We are seeking 2 experienced and highly motivated Bioanalytical and Bioassay Leads to join our Bioanalytical and Bioassay group located at Research Triangle Park, Durham NC. Reporting to the Sr. Director, the Bioanalysis and Bioassay Lead is expected to lead the bioanalytical and bioassay development and drive technical excellence within the team.
- Serve as a SME and/or lead scientist, lead and manage the internal and external bioanalytical and bioassay assay design, development, troubleshooting, transferring, and sample testing and reporting to support preclinical and clinical gene therapy program development.
- Independently develop, optimize, and troubleshoot Cell-based assays as well as other plate-based assays using variety of platforms including colorimetric/luminescent/fluorescent ELISA, MSD, and high-content imaging in support of developing release and characterization assays for gene therapy products.
- Independently develop, optimize, and troubleshoot molecular biology/biochemistry assays, such as ELISAs, MSD, enzyme activity assay, qPCR/ddPCR to meet the bioanalytical need for various AAV gene therapy programs.
- Prepare/scientific review of analytical data and methods, protocols, and reports generated by internal and external laboratories.
- Participate and present in departmental and cross-functional project team meetings.
- Author and review relevant sections of regulatory submissions support the IND/CTA and BLA/MAA submissions.
- Manage CRO relationships for assay validation and qualification.
- Stay current with the latest bioanalytical and bioassay methods and technologies, current regulatory regulation and guidance, and industry’s best practices.
Required Education & Experience
- Ph.D. in Biology, Biochemistry, molecular biology, Cell Biology, or a related field with minimum 6+ years of relevant experience and a strong publication record in peer reviewed journals or Master with 12+ years of directly related industry experience.
- Experience and expertise in virus-related research including cell culture, virus transduction, cell line development, and characterization.
- Highly experienced in experiment designing, executing, and troubleshooting for qPCR/RT-qPCR, ddPCR/RT-ddPCR, ELISA, MSD, cell-based assay, and ligand-based assays FACS, or other novel platforms.
- Previous supervisory experience in bioanalytical or cell-based assay designing, executing, and troubleshooting are highly relevant and desirable.
Preferred Skills & Experience
- Deep understanding and extensive research experience in MoA, potency, and cellular signaling pathway.
- In-depth knowledge and extensive research experience in metabolic, hematologic or neuroscience related disease.
- Strong self-starter and team player, independent strategic thinker, with a strong attention to details and excellent problem solving and complexity reduction skills.