Research Associate, Formulation & Analytical Development

About AskBio

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 have an opportunity for a Research Associate, Formulation & Analytical Development to join the AskBio team and be part of our continued success!

Position Overview

The Research Associate, Formulation and Analytical Development will be responsible to support the development, qualification and execution of analytical assays for formulation studies and stability studies. This position will provide analytical test methods development, qualification, and validation support for future non-GMP drug product release.

Job Responsibilities 

  • Execution of molecular biology and biochemistry analytical methods such as qPCR, ddPCR, ELISA, HPLC, and endotoxin.
  • Provide analytical testing support for Manufacturing to assist in the analytical characterization of new therapeutic targets and technology improvements.
  • Follow SOPs and document analytical test method procedures.
  • Organize and perform data analysis at completion of each test method.
  • Ensure lab areas are clean, organized and equipment, supplies and raw materials are available for use.
  • Contribute to technical discussions and investigations.
  • Maintain detailed, organized, and formal record keeping of all analysis.
  • Make routine revisions to SOPs, Batch Records, Analytical Records, Formulation Records and initiate new procedures as applicable.
  • Assist with inventory management of raw materials and analytical test method supplies.
  • Evaluate and summarize analytical results and final reports.

Required Education & Experience

  • Bachelor’s degree.
  • 1- 3 years of experience of experience in bio-analytical testing, development and technology transfer, preferably in rAAV and/or recombinant protein/biomolecules.
  • Previous experience and/or demonstrated skills with one or more of the following techniques: qPCR, ddPCR, ELISA, HPLC, and/or other molecular biology and biochemistry techniques.

Preferred Experience & Skills

  • Familiarity with biopharmaceutical manufacturing, regulations, and compliance.
  • Expertise in implementing and troubleshooting experiments with the ability to assume independent ownership of protocols and experiments.
  • Ability to critically analyze problems, develop potential solutions and evaluate impact to the research organization.
  • Service-oriented attitude while multi-tasking and prioritizing according to the groups goals.
  • Understanding of statistics and data analysis/interpretation.
  • Excellent communication skills with the ability to work both independently and in a team environment with people, internally and externally.
  • Proficiency with all Microsoft Office Suite Software (Word, Outlook, Excel).