Senior Research Associate - Analytical Development
About The Position
BrainChild Bio is seeking to hire a Senior Research Associate of Analytical Development to add to our growing team. The Senior Research Associate will develop, optimize, qualify and/or transfer assays for process related residuals and utilize them in support of process development studies, investigational product characterization and clinical characterization of cell and gene therapy products. The ideal candidate would have some previous experience with HPLC, immunoassay analysis, and/or particulate analysis. They will be problem solvers and be willing learn new technologies and methodologies. This candidate will also be a team player and willing to work across Research, Analytical Development and Process Development teams to understand method needs, assist with process study design/execution and analyze samples in support of process development and clinical characterization. They will also participate in ELN, batch record, SOP and method authoring.
Requirements
- BA/BS in biochemistry, biology, chemistry, or related discipline.
- 2-5 years of industry experience in a life sciences laboratory.
- Proficiency with life science data acquisition and analysis tools (Excel, Prism, JMP) and ELNs desired.
- Previous experience with analytical method qualification and transfer in accordance with ICH guidelines desired.
- Previous experience operating and maintaining HPLC instrumentation and developing quantitative chromatography methods is highly desired.
- Proficiency with single and/or multiplex immunoassay method development and techniques (ELISA, MSD, AlphaLISA, Ella, etc.) is desired.
- A team player with a track record of successfully operating within cross-functional teams.
Responsibilities
- Work collaboratively with internal BrainChild Bio Research, Process Development and Analytical Development teams and with external contract organizations, as needed.
- Design, develop, qualify and transfer HPLC methods for cellular drug product impurities
- Conduct immunoassay techniques such as ELISA and MSD.
- Perform routine sample analysis in a timely manner in support of process development studies
- Author ELNs, SOPs, Protocols and Reports
- Review and revise contract manufacturing organization Methods, Protocols and Reports
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
