Sean Ahern Email & Phone Number

United States

United States

Redwood City, California, Us

Experience working with allogeneic, and autologous manufacturing processes using viral or plasmid vectors.• Responsible for supplier qualification of GMP CMOs for clinical manufacturing of cell banks, plasmid, viral vector drug substance, donor starting material & final cellular drug products. • Responsible for supporting technical transfers as well as reviewing and releasing CMOs batch records for GMP manufacturing of donor starting material, cell banks, plasmids, viral vector drug substance, & cell therapy final product for multiple clinical trials.• QA oversight of CMOs QMS, including change controls, deviations, CAPAs, OOS, environmental monitoring, materials, review QC method validations, QC assays, & participate in client meetings.

Tokyo , Japan , Jp

QA lead of multiple active cell therapy clinical GMP manufacturing clients projects. Responsible for most QA operation aspects associated to these projects including quality agreement, technical transfer from client(training, engineering, Aseptic Process Simulation (APS), & Clinical GMP manufacturing ), development of QA documents specific to the process (BR issuance, BR review, in-process & product labels, COA, COC, BR release, product ship out) as well as QA oversight of change controls, deviations, CAPAs, critical materials, OOS, environmental monitoring, clean room qualifications, review of QC method quals/validations, QC assay document development & participating in client meetings. Developed & maintained collaborative relationships with multiple internal groups (MSAT, Clinical, QC, Operations, Supply Chain, & Facilities) to create & streamline processes and deliverables.

Microsoft Dynamics NAV ERP certification & software junior developer

London, Gb

Project Management & QA specialist team roles assisting in starting a GxP market surveillance QC laboratory in Abu Dhabi, UAE. Testing various drugs (ICH Q7) using USP testing methods including HPLC for Identification, Assay, and Confirmatory, as well as disintegration, dissolution, and various physical tablet tests.

London, Gb

GLP/GCP experience in assuring accurate specimen metadata & compliance of ELISA Toxicokinetics, Pharmacodynamics, Anti-drug Antibody, and Biomarker method validations, sample analysis, & associated reports for compliance to regulations, (FDA, EMA and MHLW) guidelines, and in accordance with study protocols/plans/data transfer agreements for multiple sponsors clinical trials. Reviewing/verifying biospecimen lifecycle management documentation from sample receipt to analysis and final disposition.

Paris, France, Fr

GMP gene therapy manufacturing facility

Ca, 92121, Us

Supporting Assay Integration studies for detection of multiple viral targets on the TIGRIS instrument Nucleic Acid Testing platform. Work included optimization of both diagnostic assays (detection of STDs in urine) and blood screening assays (detection of HIV/HBV/HCV and West Nile Virus in blood serum and plasma) for processing on an automated instrument system, also participated in the development of a HIV real-time detection assay