Senior Research Associate, Quality Control

Role Summary

Senior Research Associate, Quality Control to help us expand what’s possible for patients with serious diseases. The role involves transfer of method from Analytical Development into QC and authoring/executing qualification/validation protocols and reports to support product release, stability, and characterization. The role will perform analytical and biochemical analysis on lot release, stability, and process characterization samples to support AAV Gene Therapy products.

Responsibilities

• Collaborate with research, analytical development and process development teams to develop, qualify/validate AAV gene therapy analytical/molecular biology assays, chemical/biochemical assays, and cell-based biological potency assays, for process monitoring and product release and stability, e.g., compendial methods, HPLC, DLS, droplet digital PCR or qPCR, ELISA, and cell-based potency assays
• Participate in developing timelines, protocols and reports for assay transfers, qualifications/validations
• Contribute to establishing material specifications for drug substance and drug products
• Author and review QC analytical/equipment SOPs, protocols, and reports as needed
• Ensure the timely execution of all routine QC testing, data review, and preparation of summary report
• Perform quality management activities such as deviation, CAPA, change control, investigation of OOS, OOT and anomalous results within the company QMS according to established procedures
• Maintain QC laboratory, track critical reagents and equipment logbooks, and ensure all the equipment is calibrated

Qualifications

• BS degree or equivalent in relevant discipline with a minimum of 2 years of relevant industry experience or Master‚Äôs degree in relevant discipline with a minimum of 0 years of relevant industry experience
• Experience in pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with experience in a GMP QC release testing role
• Experience in optimizing methods with emphasis on cell-based potency assay, molecular biology assay, and protein chemistry assays
• Significant experience in an FDA-regulated environment
• Entrepreneurial spirit, with strong willingness to take on new challenges to bring novel medicines to the clinic
• Excellent organizational and communication skills
• Experience with JMP statistical software a plus

Skills

• AAV gene therapy analytical/molecular biology assays and cell-based potency assays
• Process monitoring, product release, and stability testing
• Analytical method development and qualification/validation
• Quality systems: deviations, CAPA, change control, OOS/OOT investigations
• SOP authoring and technical reporting

Education

• Bachelor‚Äôs degree or equivalent in a relevant discipline; Master‚Äôs degree possible depending on experience

Additional Requirements

• On-site, in-person role based in San Diego