Senior Analyst, Quality Control

PRIMARY RESPONSIBILITIES

• Participate in transfer and qualification activities in support of our pre-clinical and clinical programs
• Execute QC testing to support release and stability analysis for drug substance and drug product
• Manage method qualification and release testing conducted at contract testing organizations
• Conduct testing investigations and deviations to support root cause analysis and corrective and preventative actions, as required
• Implement QC systems and procedures compliant with cGMP
• Manage programs for critical laboratory reagents, assay controls/reference standard, and equipment
• Independently analyze and summarize data in technical reports and presentations
• Author, review, and/or approve data, logbooks, SOPs, CoAs, analytical methods, protocols, reports, deviations, and other quality records
• Maintain the QC Unit in a state of compliance and inspection readiness

BASIC QUALIFICATIONS

• BS/MS in biology, immunology, biochemistry or a related scientific discipline with at least 2-5 years industry experience
• Experience working in a regulated GMP QC laboratory
• Proficient in a range of analytical methods (mammalian cell culture, flow cytometry, ELISA, qPCR etc.) and aseptic technique
• Strong knowledge of US cGMP regulations/guidelines
• Detail oriented and organized with the ability to work in a fast-paced environment
• Effective communication skills, both verbal and written, across various functions including manufacturing, quality assurance, and analytical development.

PREFERRED QUALIFICATIONS

• Familiarity with the validation process