Senior Research Associate

Location: On-site in San Diego (Sorrento Valley)Length: 6+ monthsSummary:Our client is seeking a QC Senior Research Associate with broad knowledge and expertise in analytical/molecular biology assays, chemical/biochemical assays, and cell-based potency assays, as applied to AAV gene therapy products. The QC Senior Research Associate will be involved in transfer of method from Analytical Development into QC. The QC Senior Research Associate will author and execute phase appropriate qualification/validation protocols and reports of QC methods 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.Duties/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 assaysParticipate in developing timelines, protocols and reports for assay transfers, qualifications/validationsContribute to establishing material specifications for drug substance and drug productsAuthor and review QC analytical/equipment SOPs, protocols, and reports as neededEnsure the timely execution of all routine QC testing, data review, and preparation of summary reportsMay act as an analytical lab representative on a CMC teamPerform 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 calibratedSoftware Use Expectations:Utilize the LIMS system to submit samples, enter data, and track samples.Utilize statistical analysis software to generate assay control charts and recommend assay acceptance criteria.Learn and become proficient in all laboratory instrument software to conduct testing Qualifications/Requirements: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 roleExperience in optimizing methods with particular emphasis on cell-based potency assay, molecular biology assay, and protein chemistry assaysSignificant experience in an FDA-regulated environmentEntrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinicExcellent organizational and communication skillsExperience with JMP statistical software a plusBS or equivalent in relevant discipline with a minimum of 2-5 years of relevant industry experience or Master’s degree in relevant discipline with a minimum of 0-1 years of relevant industry experience