Sr Scientist, Analytical Development Group Lead
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 SCIENTIST – ANALYTICAL DEVELOPMENT GROUP LEAD to join the AskBio team!
About the Role
This role will provide the design, development, qualification and execution of analytical assays to support in-process analytics, process development, non-clinical and GMP recombinant adeno-associated virus (rAAV) vector manufacturing. This individual provides analytical test method development, qualification and validation support along with analytical method tech transfer for future non-GMP and GMP drug product release.
Responsibilities and Accountabilities
- Design, establish, develop, qualify and provide validation support for biochemical assays such as ELISA, HPLC-SEC, RP-HPLC, HPLC-IEX, Capillary Electrophoresis, Mass Spec, SDS-PAGE, DLS, residuals assays, etc.
- Lead and mentor a team of junior and senior analytical development scientists. Establish timelines and budgets associated with multiple analytical development projects. Provide analytical testing support for Process Development, R&D, GMP and external CMO teams to assist in the development and analytical characterization of new therapeutic targets
- Design and coordinate/execute qualification/validation of developed analytical methods and tech transfer the methods internally and to partner CMO
- Author development reports, study protocols, SOPs, pre-validation reports and analytical assay tech transfer documents
- Represent the analytical development team in cross-site analytical meetings, CMC meetings and assist in authoring CMC-related documentation and responses to FDA queries
- Evaluating CRO/CMO test results and writing summary reports of the results when needed
- Establish CRO relationships when needed
- Contribute to technical discussions and investigations within the analytical group and help support Process development, QC, non-clinical and GMP manufacturing
- Bring in new technologies for characterization of AAV drug products
- Detailed, organized, formal record keeping
- Has excellent communication skills and works well in a group work environment
- MS or PhD in bioanalytical chemistry, biology, biochemistry, virology or related field with at least 8-12 years’ experience
- Experience managing a team of scientists
- Demonstrated method development and qualification experience in viral safety, HPLC, ELISA, SDS-PAGE, mass spec, CE etc.
- Demonstrated analytical method tech transfer experience
- Proven ability to work in a fast-paced environment, meet deadlines and prioritize work on multiple projects. Strong attention to detail with the ability to handle multiple responsibilities simultaneously
- Must be able to generate high-quality data for presentations and publications
- Excellent interpersonal skills with the ability to interact effectively with people, internally and externally, is required
- 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
- Expertise with method development, qualification and validation following regulatory guidelines (USP, ICH, etc.)
- Prior industry experience in gene therapy is strongly desired
- Strong oral and written communication skills
- Must exhibit strong 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
Live an AskLife™
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