Sohail Jarrahian Email & Phone Number

Overseeing Quality and Compliance for a commercial Class III medical device.

A Contract Manufacturing Organization (CMO) performing integrated cGMP manufacturing services for biopharmaceuticals.• Ensure GMP compliance of production, raw material warehouse, and QC laboratory operations.• Review executed manufacturing production records and test data to support lot release for cell banks and drug substances. • Draft, review and approve SOPs, test methods, product specifications, and master production records.• Approve deviations and… Show more A Contract Manufacturing Organization (CMO) performing integrated cGMP manufacturing services for biopharmaceuticals.• Ensure GMP compliance of production, raw material warehouse, and QC laboratory operations.• Review executed manufacturing production records and test data to support lot release for cell banks and drug substances. • Draft, review and approve SOPs, test methods, product specifications, and master production records.• Approve deviations and corrective/preventive actions. Lead investigative teams for root cause determination.• Review process, analytical methods, and raw material validation protocols and reports. • Perform audits of vendors and contract testing labs. Write and review vendor audit reports.• Interface with external auditors and coordinate audit responses as quality subject matter expert.• Manage FDA pre-approval readiness team in preparation for regulatory inspection.• Serve as quality representative on client project teams. Primary point of client contact for all compliance matters.• Provide narrative summary of CMC operations in support of client regulatory submissions. Show less

• Manage contract biologics safety testing of cell banks and bulk product and serve as the primary regulatory and technical expert on all biological safety testing.• Create and review controlled documents including QC testing and environmental monitoring SOPs, quality standards, material specifications and manufacturing batch records.• Responsible for identifying root causes of excursions and writing QC investigative responses as member of Action Investigation team.• Conduct… Show more • Manage contract biologics safety testing of cell banks and bulk product and serve as the primary regulatory and technical expert on all biological safety testing.• Create and review controlled documents including QC testing and environmental monitoring SOPs, quality standards, material specifications and manufacturing batch records.• Responsible for identifying root causes of excursions and writing QC investigative responses as member of Action Investigation team.• Conduct data analysis and review. Investigate and resolve nonconformances and implement corrective/preventive actions.• Assist in validation activities related to qualification of lab equipment, product testing, GMP utilities, and manufacturing operations.• Perform various microbiological testing of raw material, in process and manufactured bulk products. Show less

A prominent gene therapy laboratory focused on the development of novel, site specific vectors for gene therapy.

A molecular virology laboratory focused on translational regulation of viral and cellular gene expression.

Masters Of Science (School Of Pharmacy), Biomedical Regulatory Affairs

Bachelor Of Science, Microbiology