Senior Research Associate

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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

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