|Title:||Senior Scientist, Analytical Development|
|Department:||Manufacturing Sciences and Technology|
Senior Scientist, Analytical Development
SwanBio is a privately held, newly established biotechnology company focused on the discovery and development of innovative gene therapy products for the treatment of central nervous system (CNS) disorders and diseases. SwanBio has a mature leadership team and is building an open, innovative culture that trusts its people, processes and science to deliver scientific, clinical and business success. Our lead investor, Syncona, is a premier health care company with a proven track record of successful long-term investment strategies in gene and cell culture companies. Our goal is to become a world-leader in treating neurodegenerative diseases. With locations in Philadelphia and Boston, the SwanBio Team is building a strong pipeline of gene therapy development leads with a directed focus on critical unmet medical needs for CNS diseases.
We are seeking a collaborative and highly technically motivated Senior Scientist with multi-disciplinary analytical development expertise to join our Manufacturing Sciences and Technology Team. The scope includes all aspects of the manufacturing of AAV-based gene therapies including monitoring/characterization of all raw materials, extractables / leachables, critical process intermediates, in-process testing support of upstream and downstream process unit operations and testing/extended characterization of drug substance and drug product. The position also participates in and contributes to formulation development and supports research and development in clinical lead selection.
- Key activities include potency related analysis (cell-based assay, others as needed) of gene therapy products to support characterization, method development/optimization, methods transfer and analytical support of process development and manufacturing
- Support preparation of Master and Working cell banks with associated documentation
- Support of development, qualification and validation of potency assays including tech transfer to CRO/CMOs
- Author/review method development reports, SOPs, validation protocols/reports, comparability protocols and technical reports
- The position also participates in and contributes to formulation development and supports research and development in clinical lead selection.
- PhD in a scientific discipline; and minimum of 4 years industry or related lab experience, or MS and 7 yrs industry experience or, equivalent combination of education + experience
- Extensive hands-on experience with development and routine assays including cell-based potency assays for biologic products. Experience with AAV testing is a strong plus.
- Experience working with various human cell lines
- Experience in CMC analytical and regulatory requirements is desirable.
- Develop, qualify/validate, and transfer fit-for-purpose QC release and stability methods
- Quality control and/or GMP experience is beneficial
- Familiar with other analytical methods used for biologics/gene therapy characterization including qPCR, ELISA and PAGE a plus.
- Must have current working knowledge of and active in the field of gene therapy or a related field;
- Demonstrated success and accomplishment in scientific creativity; sound judgment and problem-solving capabilities;
- Must be capable of working in a fast-paced, collaborative environment and managing multiple concurrent projects with a high degree of independence
- Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to quality control laboratory practices are highly desired;
- Previous leadership (team) experience is a plus.
- Ability to travel (10% travel time)
About the Benefits: The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs including bonus and stock option plans. Additionally, SwanBio Therapeutics offers all team members a comprehensive benefits program including: medical, dental, vision care, 401(k), paid vacation and Holiday time.
SwanBio Therapeutics is an equal opportunity employer.