Quality Control Analyst

The Senior QC Analyst will work with others in Quality Control and Analytical Development in a dynamic environment to support AAV-based gene therapy programs. The Senior QC Analyst will perform cell-based bioassays, ELISAs, and other biological methods in a GMP setting. In addition, the Senior QC Analyst will review, enter and approve data from external laboratories. Routine work includes release and stability testing, critical reagent qualification, method validation and transfer, critical reagent qualification, analyzing data, and authoring technical documents.

Responsibilities:

• Performing routine QC testing including, but not limited to, quantitative PCR and cell-based assays in a GMP environment to support product release and stability.
• Review and approval of cGMP analytical data for release and stability testing from bioassay test methods including, but not limited to, mRNA expression, functional potency and ELISA testing platforms.
• Supports and leads QC Bioassay laboratory operations (ex. Instrument qualification and maintenance. Passage cells, qualify critical reagents, etc).
• Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.
• Support method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs.
• Author analytical method performance trend reports, as needed.
• Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs).
• Model leadership behaviors and mentor/train junior staff
• Work with cross functional teams with both internal and external stakeholders

Requirements / Qualifications:

• BS in Cell Biology, Molecular Biology, Biochemistry or a related discipline with minimum 5+ years industry experience
• Experience in a GMP/GLP environment is a must.
• Experience in routine mammalian cell culture required
• Experience with quantitative PCR required. Experience with cell-based potency assays is required. Experience performing immunoassays such as ELISAs strongly desired
• Experience with statistical analysis (SoftMax, JMP) preferred
• Ability and desire to work in a fast-paced environment
• Strong collaboration, team-working skills, and communication skills
• Independently motivated and detail-oriented with good problem-solving ability
• Strong communication, interpersonal and organizational skills
• Quality experience -must have
• Cell-Based Assays
• cell culture
• cGMP adherence skills
• cGMP analytical testing
• Hands-on experience with performing dPCR, ddPCR and/or qPCR test method execution