Sr Research Associate | Analytical Development
Asklepios BioPharmaceutical, Inc. (AskBio) is a privately held, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy pioneers, Jude Samulski, PhD, and Xiao Xiao, PhD. We are driven to change lives with every clinical advancement and turn hope into cures with new possibilities for genetic medicine. We currently have clinical trials ongoing for late-onset Pompe disease and congestive heart failure.
AskBio is headquartered in Research Triangle Park, North Carolina, a thriving biotechnology hub, and has additional research and development facilities in Edinburgh, Scotland, and gene therapy manufacturing in San Sebastian, Spain.
We are excited for our next SENIOR RESEARCH ASSOCIATE – Analytical Development Molecular Biology to join the AskBio team!
About the role:
The purpose of the Senior Research Associate-Analytical Development Molecular Biology position is to assist in the design, development, qualification and execution of analytical assays to support in-process analytics, process development, non-clinical recombinant adeno-associated virus (rAAV) vector manufacturing and GMP rAAV vector manufacturing. This individual provides analytical test methods development, qualification and validation support for future non-GMP and GMP drug product release.
Responsibilities and Accountabilities
- Assist scientists in design and execution of molecular biology analytical assay development and qualification protocols related to viral titer assays, residual DNA assays and sequencing that include TCID50, qPCR, ddPCR, PCR, Sanger and NGS sequencing etc.
- Provide analytical testing support for process development, R&D and external CMO teams when needed to assist in the development and analytical characterization of new therapeutic targets
- Ensure lab areas are clean and organized and equipment, supplies and raw materials are available for use
- Execute qualification/validation of developed analytical methods
- Author development reports, study protocols, SOPs and pre-validation reports
- Contribute to technical discussions and investigations within the analytical group
- Detailed, organized, formal record keeping
- Has excellent communication skills and works well in a group work environment
- BS or MS in bioanalytical chemistry, biology, biochemistry, virology or related field with at least 2-5 years’ experience
- Must possess skills in qPCR, ddPCR, mammalian tissue culture and other molecular biology techniques.
- Prior experience in analytical method development setting for analytical assays is a must
- Ability to manage multiple projects and teams and work independently in a fast-paced, highly interactive environment
- Excellent interpersonal skills with the ability to interact effectively with people, internally and externally, is required
More about you:
- Must be self-motivated, organized, capable of working independently, as well as in a collaborative/group environment to collaborate with manufacturing process development staff on experimental studies
- Must have mammalian tissue culture experience and familiar with aseptic techniques
- Familiarity with method development and validation following regulatory guidelines (USP, ICH etc.)
- Possess strong oral and written communication skills
- Must exhibit analytical method development skills, with use of statistics and design of experiments highly desirable
- Good judgment and innovation to achieve a solution within standard practices and procedures
- Experience with global teams, especially Spanish speaking, a plus