Job Details

Duties:

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 cell-based biological potency assays, protein chemistry assays, and molecular biology assays for process monitoring and drug product release, specifically droplet digital PCR, HPLC, ELISA, culture of primary mammalian cells, and cell based potency assays.

Participate in developing timelines, protocols and reports for assay transfers, qualifications / validations.

Author and review QC analytical SOPs, protocols, and reports as needed

Ensure the timely execution of all routine QC testing, data review, and preparation of summary reports

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

Skills:

Seeking a QC Scientist I with broad knowledge and expertise in cell-based potency assays, molecular biology assays, and chemical/biochemical assays as applied to AAV gene therapy products. The QC Scientist will be involved method development and/or method transfer. The QC Scientist will author and execute phase appropriate qualification/validation protocols and reports of QC methods to support product release and stability. The role will perform analysis on characterization, lot release and stability samples for clinical phase AAV Gene Therapy products.

Education:

BS or equivalent in relevant discipline with a minimum of 4 years of relevant industry experience or Master's degree in relevant discipline with a minimum of 1 year 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 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.