Associate Scientist, Analytical Development
Frontera Therapeutics is seeking an Associate Scientist to join our Analytical Development team. This team is responsible for the development of analytical methods for our AAV-based gene therapy products. This individual will participate in the analytical assay development, qualification, method transfer, assay validation support, assay remediation, and analytical testing support. This person will provide technical expertise in analytical development for cross-functional project teams and CMC teams, establish analytical assay capability and interacts extensively with other groups within Frontera, including Upstream, Downstream, and Research team.
- Establish critical analytical assays, participate in building up a new analytical lab for the method development and optimization, as well as the testing support of PD studies including qPCR and ddPCR, HPLC, ELISA, Cell-based assay, SDS-PAGE, Western Blotting, and other requested assays
- Develop and transfer qualified assays to QC or CRO, and support assay validation and assay trouble shooting
- Provide analytical support in cross-functional project teams, investigation teams and the CMC teams
- BS or MS in Analytical Chemistry, Chemical Engineering, Biochemistry, Biophysics or related disciplines with 0-3+ years of relevant industrial experience
- Hands-on experience in analytical development of biologics is required, experience in viral vaccines or gene therapy is a plus (including qPCR, ddPCR, ELISA, SDS-PAGE, HPLC, cell-based assays)
- Experience of assay development and qualification with EMA/FDA regulations, ICH guidelines, GMP and quality systems is a plus
- Strong communication skills, including writing and oral presentations
- Strong technical and analytical skills
- Take initiative, being willing to work in a fast-paced environment with demonstrated capacity to handle multiple tasks and demands
- Pro-active attitude, flexible, professional, independent and a team player
Frontera is a leader in life-changing therapeutics that reach patients around the globe. Because of our innovative development platform, our treatments are accessible to patients regardless of geography or livelihood. Frontera's rich product pipeline covers multiple therapeutic areas and is in various stage of development. Frontera is well funded, and has an experienced management team, rich pipelines, and world class Scientific Advisory Board (SAB) members.