Director Virology

Role Summary

Director Virology to lead and own the viral safety program for our bulk biopharmaceutical manufacturing facility. This leadership role works with regulatory authorities, maintains compliance with domestic and international regulations, and drives the effectiveness of viral control strategies. The role ensures the safety and compliance of a cutting-edge biopharmaceutical manufacturing facility and directly impacts the success of operations and the viral safety program.

Responsibilities

• Developing, implementing, and continuously improving the viral control strategy for the facility
• Managing virology development laboratory, creating modern molecular and next generation sequencing (NGS) assays to test for adventitious agents in cell banks and bulk harvests. Developing and implementing strategy for introducing these methods into new and commercial regulatory filings.
• Reviewing and enhancing protocols for viral detection, containment, and decontamination in laboratory and manufacturing environments
• Periodically testing program effectiveness to ensure operational excellence
• Overseeing the GMP aspects of the viral clearance assurance program to support regulatory filings while collaborating with internal and external laboratories to maintain compliance
• Leading investigations and troubleshoot equipment, testing, and process abnormalities related to virology, addressing virological abnormalities and implementing corrective actions
• Representing QC Virology during regulatory inspections and audits

Qualifications

• Required: PhD in virology or a related field (or relevant experience in biopharmaceutical virology in lieu of advanced degree)
• 10+ years in GMP biopharmaceutical/pharmaceutical environment
• At least 5 years in a management role
• Experience presenting/defending positions in audits or regulatory inspections
• Strong experience in virology within the biotechnology/pharmaceutical industry
• Commitment to staying current with advancements in the field

Skills

• Regulatory compliance and inspection leadership
• Viral safety program development and management
• Molecular assay development and NGS assay implementation
• GMP operations and viral clearance strategies
• Cross-functional project leadership

Education

• PhD in virology or related field preferred; relevant biopharmaceutical virology experience may substitute for advanced degree

Additional Requirements

• Travel: Not specified as essential
• Physical demands: Not specified as essential