Director Virology

Role Summary

Director Virology – lead and own the viral safety program for a bulk biopharmaceutical manufacturing facility, ensuring compliance with domestic and international regulations and driving the effectiveness of viral control strategies. The role involves collaboration with regulatory authorities and shaping the safety and compliance of a cutting-edge biopharmaceutical manufacturing environment.

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 related field (optional consideration for relevant biopharmaceutical virology experience 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; familiarity with domestic and international viral safety regulations
• Ability to lead and participate in cross-functional project teams

Skills

• Viral safety program development and management
• Viral detection, containment, and decontamination protocols
• GMP regulatory compliance and surveillance
• Laboratory management and oversight of virology development labs
• Molecular assays and next-generation sequencing (NGS) for adventitious agent testing
• Regulatory inspection preparation and defense

Education

• PhD in virology or related field (preferred)