Research Associate II
• Perform Bioassay development and validation to support CMC biological potency assays for product characterization and quality control testing.
• Exercise technical discretion in the design, execution and interpretation of experiments that contribute to project strategies.
• Maintain a high level of professional expertise through extensive cell culture and assay development experience.
• Work in a matrix system to support related functions such as CMC and cell-based assays.
• Takes responsibility to deliver scientific excellence and technical rigor in cell-based assay biological potency assay development for product characterization and QC lot release use.
• Independently executes technical experiments following appropriate guidance and technical procedures.
• Effectively communicate with internal and external clients (CRO) for assay related technical details.
• Collects and analyzes data to prepare technical reports, summaries, protocols, and/or quantitative analyses.
• Maintains accurate and well-organized laboratory records, work sheets and notebooks.
• Maintains current training requirements.
• Maintains compliance to company Environmental Health and Safety policies, procedures and practices.
Education & Qualifications
• A minimum of a Bachelor degree in a scientific discipline with 2 years work experience in a research and/or development environment is required.
• Must have excellent analytical skills and be detail oriented.
• CMC, GLP/GMP and clinical research experience are desirable.
• Working experience on ELISA, cell-based assay are plus.
• Strong organizational skills, good computer skills include MS word, Excel, Power point are required.
• Must be able to work well and promote a team environment.
• Medical, Dental, and Vision Insurance
• 401K Plan with Company Match
• Life and AD&D Insurance