Title: | Scientist, Analytical Development |
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ID: | 1034 |
Location: | N/A |
Department: | N/A |
About SwanBio Therapeutics
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 deeply experienced leadership team and is building an open, innovative culture that trusts its people, processes and science to deliver scientific, clinical and business success. SwanBio’s lead investor is Syncona, a premiere investment partner focused on building companies delivering transformational healthcare treatments. Sycona has a deep pool of capital and they are established leaders in the development of genetic medicine. In particular, they present a legacy of success in long term investment strategies for companies in the Gene and Cell Therapy space. 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 programs with a directed focus on critical unmet medical needs for CNS diseases.
The Opportunity
We are seeking a collaborative and highly technically motivated Scientist with multi-disciplinary analytical development expertise to join our Analytical Development Team. The scope includes all aspects of testing and characterization of AAV-based gene therapies including 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.
Key Responsibilities:
In this role you will:
- Conduct 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 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
- Participate in and contribute to formulation development and supports research and development in clinical lead selection.
Basic Requirements:
- PhD in a scientific discipline; and minimum of 0-2 years industry or related lab experience, or MS and 4 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)
Skills:
- Excellent problem-solving ability
- Excellent people Skills
- Excellent Organizational skills
- Exceptional interpersonal skills
- Ability to multi-task
- Possess a mind-set of no job too big or too small
- Results and detail oriented\
- Exceptional analytical skills
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