Manager Quality Assurance, Microbiology (Drug Product)

About the role

Manage direct reports, including performance management
Foster collaborative relationships across Regeneron departments
Observe microbial/aseptic practices in classified areas; provide feedback and improvement recommendations
Maintain current expertise in microbiological practices per industry and Regeneron standards
Analyze Environmental Monitoring (EM) data and guide trending efforts
Review microbial control documents (SOPs, validation/qualification docs, protocols, technical documents, training materials)
Provide technical expertise on contamination investigations—root-cause analysis, corrective actions, product impact, and remediation
Conduct facility walkthroughs for inspection readiness
Serve as microbiology subject matter expert for contract manufacturing operation (CMO) quality audits, contributing to audit reports
Develop microbial/aseptic training content, including simulated production scenarios and presentations on processes, expectations, and regulatory requirements

Responsibilities

• Manage direct reports, including performance management
• Foster collaborative relationships across Regeneron departments
• Observe microbial/aseptic practices in classified areas; provide feedback and improvement recommendations
• Maintain current expertise in microbiological practices per industry and Regeneron standards
• Analyze Environmental Monitoring (EM) data and guide trending efforts
• Review microbial control documents (SOPs, validation/qualification docs, protocols, technical documents, training materials)
• Provide technical expertise on contamination investigations—root-cause analysis, corrective actions, product impact, and remediation
• Conduct facility walkthroughs for inspection readiness
• Serve as microbiology subject matter expert for contract manufacturing operation (CMO) quality audits, contributing to audit reports
• Develop microbial/aseptic training content, including simulated production scenarios and presentations on processes, expectations, and regulatory requirements

Requirements

• BS/BA in Life Sciences or related field; or equivalent combination of education and experience
• Associate Manager QA Microbiology: 6+ years of relevant experience
• Manager QA Microbiology: 7+ years of relevant experience
• Sr. Manager QA Microbiology: 8+ years of relevant experience
• Previously people leadership/supervisory experience

Qualifications

• BS/BA in Life Sciences or related field; or equivalent combination of education and experience
• Associate Manager QA Microbiology: 6+ years of relevant experience
• Manager QA Microbiology: 7+ years of relevant experience
• Sr. Manager QA Microbiology: 8+ years of relevant experience
• Previously people leadership/supervisory experience

Skills

• Strong knowledge of microbiological practices and industry standards
• Experience in microbial control activities for drug development and commercialization
• Excellent analytical and problem-solving skills
• Effective communication and collaboration skills
• Ability to lead and mentor a team
• Proficiency in regulatory compliance and auditing

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 (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

Pay

$92,200.00 - $206,100.00 annually

Schedule

Monday-Friday, 8am-4:30pm

Location

Rensselaer, New York, United States