Job Description
Primary Responsibilities
Accountable for the development, coordination and execution of method development, optimization, transfer and validation of analytical and bioanalytical assays including but not limited to the Identity, Purity, Quantity and Potency assays and characterization methods supporting Drug Substance and Drug Product for research, preclinical and clinical use.
Accountable for the management of contracted analytical and bioanalytical testing to meet the needs for quality, compliance and business imperitives including tracking, submitting reports and supporting data.
Organizes and prepares analytical and quality control components of CMC regulatory filings including descriptions of test methods, qualification/validation summaries, specifications, specification justifications and test results.
Provide responsive, timely and high integrity assay service function for research and development and ongoing stability studies.
Ensure Analytical instruments are operating correctly with minimal downtime with good use practices, routine maintenance, troubleshooting problems and obtaining outside service.
Any other duties as assigned
Qualification / Education / Experiences / Skills
BS and above in Chemistry, Analytical Chemistry, Biochemistry or related discipline.
Degree and relevant pharmaceutical/biotechnology development experience: 3 years with Ph.D., 6 years with MA, 8 years with BS.
Familiarity with ICH guidelines on API, product specifications, stability, assay validation
Experience in Protein Analytical Chemistry, Biochemistry, Molecular/Cell Biology and Statistics required. Virology and immunology experience and GMP and GLP experience highly desirable. Hands-on development and troubleshooting experience with various analytical and biological assays are required.
*Must have strong written and verbal communications skills.
*Must be capable of working in a fast-paced, collaborative environment and managing multiple concurrent projects with a high degree of independence.