Scientist, Formulation Development
- Plan, design and execute univariate/multivariate studies to develop robust and manufacturable formulations and DP processes
- Process data, compile results, report and communicate study findings
- Develop and implement Client biochemical and biophysical methods suitable for cell and gene therapy product characterization.
- Lead and/or participate in CMC/project teams for functional representation as well as support teams objectives and project deliverables.
- Author and review technical protocols and reports to document study findings in support of Investigational New Drug (IND), IND amendments, BLA, as well as global marketing application submissions.
- Partner with internal/external manufacturing and quality for process improvement, transfers, compilation and review of batch records, master production records and technical support to resolve investigations, deviations, corrective/preventative actions.
- Excellent communication and interpersonal skills, with proven ability to work effectively in cross-functional teams to meet project milestone and timelines.
- BS/MS/PhD degree in biochemistry, pharmaceutical sciences, biochemical engineering, or related discipline.
- 1-3 years of laboratory experience in biotechnology or pharmaceutical industry.
- Experience with biologics formulation development, DP process design and manufacturing Fill/Finish is highly desirable, however, academic experience related to cell culture, analytical chemistry, viral vectors, or gene therapy will be considered.
- Proficiency with applying chromatographic (HPLC, UPLC, column chromatography) methods, capillary electrophoresis and biophysical techniques (UV-vis, DLS, CD, FTIR, DSC, AUC, Fluorescence, particle analysis, etc.) for formulation characterization
- AAV gene therapy, Cell Therapy & Gene Editing experience is desirable
- Sound understanding of statistical methods and data analysis tools (e.g. JMP).
- Team player, with good interpersonal and organizational skills.
Job Type: Contract
Location: Brisbane, CA
Job ID: 21-07351
Date Updated: September 17, 2021