Clinical/Scientific

VTekis Consulting LLP•San Diego, CA

15h

About The Position

Insmed is seeking a QC Scientist with broad knowledge and expertise in chemical/biochemical assays and molecular biology 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 Insmed AAV Gene Therapy products.

Requirements

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 developing 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

Nice To Haves

Experience with JMP statistical software a plus.

Responsibilities

Collaborate with research, analytical development and process development teams to develop, qualify/validate AAV gene therapy protein chemistry assays, and molecular biology assays for process monitoring and drug product release, such as HPLC, ELISA, CE-SDS, western immunoassay, droplet digital PCR or qPCR, culture of primary mammalian cells, and cell‑based potency assays.
Collaborate with research, analytical and process development teams to determine critical quality attributes (CQAs), monitor process and method performance, and troubleshoot
Develop 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 SOPs, protocols, and reports
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
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.