Sr. RA/Assoc. Scientist - Bioanalytical
Essential duties and responsibilities include the following:
• Design, develop and execute PK and ADA assays in accordance with current industry standard for drug candidates in support of preclinical and clinical stage oncology programs.
• Analyze, summarize, interpret and present results in reports and tables, facilitating follow-up optimization experiments
• Author protocols, reports and SOPs in support of preclinical and clinical studies
• Effectively communicate with other departments within the organization as well as CROs.
• Provide project summaries/reports in project team meetings.
• BSc. / M.S. in relevant scientific discipline and at least 5+ years of bioanalytical laboratory experience a must. Pharmaceutical, biotechnology or CRO experience highly desirable.
• Extensive knowledge of different PK and ADA formats (LBA, ELISA, MSD, Gyros, Quanterix Simoa etc.) and industry assay validation requirements a must
• Knowledge of other non-ELISA based formats such as Mass-spec, Capillary electrophoresis a plus
• Knowledge of SOP and GLP compliance, terminology and documentation
• Knowledge of current FDA and EMA GLP/GCP compliance as it relates to bioanalytical PK and ADA methods
• Proven ability to think critically and creatively to identify and solve bioanalytical assay development challenges.
• Excellent written and verbal communication skills, and ability to write technical reports.
• Excellent organizational skills, attention to detail and the ability to work independently and within a multi-disciplinary environment as well as with external vendors
• Must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.