Bioanalytical and Bioassay Lead
Company: Asklepios BioPharmaceutical, Inc. (AskBio)
Posted on: January 15, 2022
About AskBioAsklepios 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.
Position OverviewThe Bioanalytical and Bioassay Lead, reporting to
the Sr. Director, Bioanalytical and Bioassay will be expected to
lead the bioanalytical and bioassay development and drive technical
excellence within the team at AskBio's facility in Durham, NC. The
ideal candidate will be a self-starter, strategic thinker, and team
player with a strong attention to detail, excellent problem solving
and complexity reduction skills.
- 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
- 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
- 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
- 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 and expertise in virus-related research including
cell culture, virus transduction, cell line development, and
- 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
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.
- Previous supervisory experience in bioanalytical or cell-based
assay designing, executing, and troubleshooting.
Keywords: Asklepios BioPharmaceutical, Inc. (AskBio), Durham , Bioanalytical and Bioassay Lead, Other , Durham, North Carolina
Didn't find what you're looking for? Search again!