Scientist II/III, Bioassay Liver
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 a Scientist II/III, Bioassay Liver 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 an experienced and highly motivated hepatic scientist to develop organ specific bioassays, lead pre-qualification, and GXP pre-validation of in vitro/in vivo liver bioassays to support preclinical and clinical gene therapy programs. The incumbent will be responsible for bioassay development strategies and providing technical guidance to scientists. Additional responsibilities include presentation to cross-functional development teams and support the IND/CTA and BLA/MAA/NDA submissions. This role will report to the Director/Sr Director of Bioanalytical in the Translational Medicine group.
The successful candidate will have prior experience in designing, executing, and troubleshooting cell-based and/ or ligand-based assays. The ideal candidate for this position is expected to ensure on-time delivery and interpretation of results and to drive technical excellence within the translational medicine team.
Responsibilities and Accountabilities
Serve as SME and/ or a lead scientist for development, qualification, and validation of hepatic cell-based methods such as Mechanism of Action, Potency, in vitro bioassays; and/ or ligand-based methods, AAV distribution assays and biomarker testing.
- Independently develop cell-based assays to evaluate AAV gene therapy vectors targeting rare diseases and metabolic disorders.
- Optimize and troubleshoot cell-based assays as well as other plate-based assays using variety of platforms including but not limited to luminescent/fluorescent readouts MSD, and high-content imaging in support of developing release and characterization assays for gene therapy products.
- Develop and perform routine molecular biology/biochemical assays, such as western blotting, capillary electrophoresis, ELISAs, and ddPCR to support various programs.
- Participate in exploratory assay development efforts to bring new technologies or assays to the Bioanalytical team.
- Documents experimental results in electronic laboratory notebook and drafts technical reports detailing method development, qualification, and/or validation.
- Proficient using instruments and their corresponding software and statistical software such as GraphPad Prism.
- Interacts with team members and management to discuss data and project progress.
- Ensures timely completion and compliance with GLP and all other relevant company training requirements.
- Master’s degree in Biology, Biochemistry, Chemistry, or equivalent with 5-9+ years of relevant experience or Doctorate degree with 2-6+ years of relevant experience required.
- 2+ years of experience in Pharmaceuticals/Biopharmaceuticals in a GLP or cGMP setting is required.
- Expertise in developing analytical programs for one or more of the following products: peptides, monoclonal antibodies/recombinant proteins, cell therapy and gene therapy.
- Experience analyzing liver homogenates and/or working with liver cell lines is required. In depth understanding and experience with viral transduction protocols.
- Familiar with cell-based assays as well as other plate-based assays using variety of platforms including but not limited to ELISA, MSD, high-content imaging, and luminescent/fluorescent plate reader.
- Prior experience with technical writing such as drafting SOPs for method validations and instrument qualifications, and general GDP experience is preferred.
- Must be able to work in BSL2 and BSL2+ environment.
- Ability to work independently on routine work, and with general instructions on new assignments.
- Chromatography experience is preferred.
AskBio is an equal opportunity employer. We will not tolerate discrimination on the basis of race, color, national origin, sex, sexual orientation, gender identity, religion, age, disability, veteran’s status, pregnancy, genetic information or on any basis prohibited by federal, state or local law.
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Equal Opportunity Employer
Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements.
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