Job: Senior Scientist, Analytical Development, Asklepios BioPharmaceuticals Inc, Durham, NC
Senior Scientist, Analytical Development
Durham, NC 27709 United States
Research and Development
When AskBio’s scientific founder, Dr. Jude Samulski, discovered how the Adeno-Associated Virus (AAV) could be safely used to deliver corrected genes to cells with genetic defects, it propelled one of the most exciting and inspiring fields in medical research today. Now the foundation for an entire industry, it also inspired the development of a world-leading gene therapy platform that includes the Pro10TM cell line, an extensive capsid library, and new methods for lowering the cost of delivery.
We know gene therapy is a highly complex business. But seeing the impact that gene therapy can have on patients suffering from incurable diseases fuels a never-ending passion to continually advance AAV gene therapy technology. We embrace the work that companies like Pfizer/Bamboo, Novartis/AveXis, and Roche/Spark are doing to advance gene therapy development as we all share a common goal: erase genetic disease.
We are a company on the forefront of the industry, guided by the vision and unparalleled expertise of Dr. Samulski, the founder of AAV gene therapy. We invite all researchers, advocacy groups, patients and their families to join us on this mission to advance promising gene therapies and to change the face of health care.
We are excited for our next Senior Scientist, Analytical Development to join the AskBio team!
About the role:
The purpose of the Senior Scientist position is to provide the designing, development, qualification and execution of analytical assays to support In-process analytics, Process Development and non-clinical recombinant Adeno-associated virus (rAAV) vector manufacturing. This individual provides analytical test methods development, qualification and validation support for future non-GMP drug product release.
Responsibilities and Accountabilities
• Design, establish, and develop Viral Infectious titer assays including TCID50, Safety (rcAAV) and Potency assays
• Develop qPCR/ddPCR and ELISA-based Viral quantitation assays for viral AAV products
• Develop methods for protein analysis such as – SDS-PAGE, BCA, Western blots, RT-qPCR, etc.
• 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.
• Design and coordinate/execute qualification/validation of developed analytical methods and tech transfer the methods to partner CMO.
• Author development reports, study protocols, SOPs and pre-validation reports.
• Evaluating CRO/CMO test results and writing summary reports of the results when needed.
• 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 AAV drug products.
• Detailed, organized, formal record keeping through lab notebooks.
• Has excellent communication skills and works well in a small group work environment.
MS or PhD in Bioanalytical Chemistry, Biology, Biochemistry, Virology or related field with at least 3-6 years’ experience.
Demonstrated method development and qualification experience in viral safety, potency, viral infectious titer, qPCR/ddPCR, TCID50, etc.
Proven ability to work in a fast-paced environment, meet deadlines, & 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.
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
Prior industry experience in gene therapy is strongly desired
Should possess 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.
Must have a passport and are able to physically travel to remote locations, including, but not limited to, international and remote locations.
Must be able to tolerate normal office climatic conditions associated with daily activities.
We offer a competitive total rewards package. Are you our next great discovery?
**Please note, AskBio does not provide sponsorship at this time**
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