Associate Director Virology

About the role

This is primarily a technical role responsible for ownership and disposition of an effective viral safety program for a bulk biopharmaceutical manufacturing facility. The individual will assess the current status, develop a robust program and enact improvements based on industry best practices and regulatory concerns. Additionally, this person will act as a senior management advisor for all virology related matters. Location: Rensselaer, New York, United States.

Responsibilities

• Evaluating and establishing viral control strategy and implementing remediation efforts where necessary.
• Reviewing procedures and protocols for viral detection, containment and decontamination.
• Interfacing with Regulatory Authorities and maintaining an up-to-date awareness of regulatory issues related to viral control.
• Providing scientific oversight for the virology program and report management.
• Developing a broad understanding of virological subtleties with respect to the biotechnological processes and staying current with technical and professional literature.
• Developing and approving test protocols.
• Approving and performing investigations and remediation plans.
• Playing an integral part in investigating and troubleshooting equipment, testing and process abnormalities related to virology.
• Leading investigations related to virological abnormalities.
• Participating in laboratory investigations to ensure effective root-cause analysis and corrective action plans determination.

Requirements

• PhD in virology or related field preferred; will consider substituting relevant experience in biopharmaceutical virology in lieu of advanced degree.
• Minimum 10 years in GMP biopharmaceutical/pharmaceutical environment.
• Experience participating in regulatory inspections, presenting/defending positions in audits or regulatory inspections.

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

Pay

Salary Range (annually): $147,800.00 - $241,200.00

Schedule

Monday–Friday, 8:00 am–4:30 pm