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 have 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 to join the AskBio team in our Research Triangle Park (Durham), NC location and be part of our continued success!
About the Role
Independently design, establish and develop novel qPCR and ddPCR methods for quantification of recombinant adeno associated viral (rAAV) vector and other impurities in the AAV drug products. Establish and develop ELISA-based titration assays for quantification of rAAV capsids. Design and coordinate/execute qualification/validation of developed analytical methods and tech transfer the methods internally and to partner CMO. Establish and develop HPLC, DLS, DSF and other biochemistry-based assays for characterization of rAAV capsids. Provide analytical testing support for Process Development, R&D, and external CMO teams to assist in the development and analytical characterization of new therapeutic agents. Serve as an in-house subject matter expert (SME) technical lead for qPCR and ddPCR techniques. Author development reports, study protocols, SOPs, pre-validation reports and analytical assay tech transfer documents. Evaluate CRO/CMO test results and writing summary reports of the results when needed. Mentor junior scientists. Provide analytical testing support for Process Development, R&D and external CMO teams to assist in the development and analytical characterization of new therapeutic targets. Contribute to technical discussions and investigations within the analytical group and help support process development and non-clinical manufacturing. Bring in newer technologies for characterization of rAAV drug products.
Must have a Master’s degree in Bioanalytical Chemistry, Biology, Biochemistry, Virology, or related field or foreign equivalent, plus three (3) years of experience in the job offered or Scientist, Research Associate, Associate Scientist, Chemist, Molecular Biologist, Pharmacologist, Virologist, Research Analyst, Lab Technician, Quality Control Chemist/Analyst, or related.
Must have the following experience:
(1) Technical expertise of qPCR and ddPCR.
(2) Method development, method qualification validation, and analytical assay development.
(3) Expertise of ELISA, HPLC, and other biochemistry techniques.
(4) Analytical, technical and scientific writing and data presentation skills.
(5) GMP and GLP regulatory compliance expertise.
Candidates must possess work authorization for their intended country of employment.
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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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