Senior QC Research Associate

Schedule: Full-time, 40 hours/week, 6 month contract (Possible conversion at conclusion of contract)

The Research Associate will support pharmaceutical and analytical development activities with a focus on QC testing for AAV gene therapy products. This role will be responsible for executing, qualifying, and validating analytical, molecular biology, biochemical, and cell-based potency assays to support product release, stability, and process characterization in a GMP environment.

• Develop, transfer, qualify, and validate analytical, molecular biology, biochemical, and cell-based potency assays for AAV gene therapy products
• Perform routine QC testing for lot release, stability, and process characterization samples
• Author, review, and execute SOPs, protocols, and validation/qualification reports
• Support assay transfers from Analytical Development into QC
• Establish and support material specifications for drug substance and drug product
• Utilize LIMS for sample submission, data entry, and sample tracking
• Perform data review, trending, and preparation of summary reports
• Generate assay control charts and support acceptance criteria using statistical software
• Participate in deviations, CAPAs, change controls, and investigations (OOS/OOT) within the QMS
• Maintain QC laboratory operations, including reagent tracking, equipment logbooks, and calibration
• Collaborate cross-functionally and represent QC on CMC teams as needed

• Bachelor’s degree in a relevant scientific discipline with 2–5 years of industry experience or Master’s degree with 0–1 years of industry experience
• Hands‑on GMP QC experience in an FDA‑regulated pharmaceutical environment
• Experience with analytical, molecular biology, and cell‑based potency assays
• Familiarity with assay lifecycle from development through QC release testing
• Strong documentation, organizational, and communication skills

• Analytical & Compendial Methods
• HPLC, DLS, ELISA
• qPCR and droplet digital PCR
• Cell‑based potency assays
• Assay transfer, qualification, and validation
• SOP authoring and review
• LIMS and laboratory instrument software
• Statistical analysis software (JMP preferred)

• Experience with AAV gene therapy products
• Ability to optimize assays and troubleshoot complex methods
• Self‑starter mindset with flexibility to support fast‑paced development programs