A leading multinational biopharmaceutical organization is seeking a Quality Control Project Lead in Viral Vector/Gene Therapy to join their growing Quality Control Team! This company has recently been officially approved by the FDA for commercial production of gene therapy. With that being said, the company is booming and this is such an exciting time to join their team of QC leaders!
Key Job Responsibilities:
- Represents the QC department on project team meetings to provide applicable QC groups of relevant information such as production schedules and information requests
- Assists in the initial assessment of new products and processes such as conducting QC assessment of new raw materials.
- Conducts technical review of Statements of Work (SOWs).
- Authors, reviews, and/or provides approval of Test Records/Forms, Specifications, and Sampling Plans.
- Direct QC related tech transfer activities such as generating of a QC master transfer plan, project timelines, method specific assay transfer protocols and reports, and training plans.
- Participates in designing qualification, and validation protocols.
- Participates in providing responses to audits, deviations, out of specification (OOS) investigations, and CAPA.
- Bachelor's Degree (B.S.), preferably in Microbiology/Biology
- Minimum of 5 years of experience in QC laboratory.
- Experience with method validation and technology transfer is a must.
- Working knowledge of biological cell based assays such as PCR, flow cytometry, and ELISA is preferred.
- Experienced in cell or gene therapy products is a plus.
- Experienced in SAP and TrackWise systems is a plus
- Experienced with internal and external audits.
- Experienced with FDA audits is a plus.