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Representative responsibilities will include, but not necessarily be limited to, the following:
- 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 reports May act as an analytical lab representative on a CMC team
- 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 Software 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
Skills:
- 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.
Education/Experience:
- BS 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
- 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 particular 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 required to bring novel medicines to the clinic
- Excellent organizational and communication skills
- Experience with JMP statistical software a plus.
CR1_1772122594