The senior scientist will be responsible for assay development, troubleshooting, and routine execution of various analytical methods with minimum supervision in order to support Lentivirus and AAV based in vivo gene therapy product development. The candidate will independently analyze and present data at CMC and cross-functional team meetings. The candidate will be responsible for implementing and establishing detailed protocols for analytical methods and training junior staff in the company to ensure methods are appropriately performed. The candidate will also be integrated into other areas of CMC activities including, but not limited to, process and formulation development and external partner management in order to support drug development of Spirovant’s gene therapy products.
Responsibilities:
- Design and implement various analytical methods, analyze data, and present results to various stakeholders
- Serve as technical lead for analytical methods development and implementation
- Perform analytical assays to support internal process development
- Author analytical methods protocols and SOPs
- Train junior staff to perform analytical methods
- Participate in CMC activities such as release / characterization testing, stability program, etc.
- Contribute to regulatory submissions
Requirements:
- PhD with 1-3 years of post-graduation experience or MS with 4-6 years of post-graduation experience in Biological sciences or equivalent
- Preferred experience in GLP and/or GMP regulated environments
- Extensive hands-on experience in DNA / RNA extraction, qPCR / RT-PCR, ddPCR / RT-ddPCR, ELISA, western blot, FLOW, and mammalian cell culture is required
- Experience in viral vector transduction and general knowledge of viral vector based in vivo gene therapy are highly desired
- Basic understanding of viral vector drug substance bioprocessing unit operations (upstream and downstream)
- Experience in analytical method development, qualification and implementation is required
- Working knowledge of statistical design, modeling and application to data is preferred
- Ability to adapt and perform in a fast paced and changing environment
- Meticulous record-keeping and documentation practices, experience with electronic laboratory notebooks preferred
- Ability and willingness to train, mentor and guide junior staff
Spirovant is committed to fostering a diverse, inclusive environment and is proud to be an equal opportunity employer.