Director, QA Microbiology (Drug Product Manufacturing)
Regeneron
5 months ago
On-site
East Greenbush, NY
Operations
Director QA Microbiology
Responsibilities:
- Own and elevate the site-wide bioburden control and sterility assurance program; execute targeted remediation to sustain control.
- Maintain alignment with evolving industry and regulatory standards for microbial control; pilot and deploy new monitoring technologies within the IOPS system.
- Strengthen environmental monitoring SOPs and validation for fitness for purpose and regulatory conformance.
- Trend and interpret bioburden and environmental monitoring (EM) data; escalate and explain excursions; drive cross-functional actions and brief senior leadership.
- Build a value-added microbiology program aligned with quality, regulatory, and legal requirements.
- Define microbiology KPIs and dashboards; lead continuous improvement.
- Embed quality tools and formal risk management (e.g., FMEA, HACCP, fault tree analysis) across program elements.
- Proactively update strategies, procedures, and controls to remain compliant and effective.
- Make timely, science-based decisions to protect patient safety; communicate risk, rationale, and outcomes.
- Resolve complex technical challenges while harmonizing with global regulatory standards to support reliable product release.
- Serve as the drug product site’s microbiology authority and primary interface to regulators and internal/corporate partners.
- Translate program vision into executable action plans with clear owners, timelines, and success metrics.
- Ensure transparency of the Microbiological Control Strategy and engage the organization in execution.
- Lead, develop, and upskill managers and specialists; allocate resources based on priorities, risk, and business needs.
- Set high performance standards, coach teams, and enforce accountability.
Qualifications/Required:
- Bachelor’s degree in microbiology, medical technology, biology, or related field.
- Director experience in pharmaceutical/biotech industry:
- Associate Director: 10+ years
- Director: 12+ years
Preferred/Role May Be For You If You Have:
- Comprehensive knowledge of microbiological expectations across drug development, pharmaceutical technology, and drug manufacturing; knowledge of CMC and GMP; strong understanding of drug laws, global regulations, and guidelines.
- Experience building quality culture and quality management capabilities.
- Comprehensive knowledge/experience with CMC content for submissions (IND, BLA, CBE, PAS) and equivalent European submissions.
- Ability to think and operate in a rapidly evolving/ambiguous environment; strong leadership and written/oral communication.
- Intellect for quality risk identification, mitigation, and management.
Application instructions:
- Apply now to take your first step toward living the Regeneron Way.
Responsibilities:
- Own and elevate the site-wide bioburden control and sterility assurance program; execute targeted remediation to sustain control.
- Maintain alignment with evolving industry and regulatory standards for microbial control; pilot and deploy new monitoring technologies within the IOPS system.
- Strengthen environmental monitoring SOPs and validation for fitness for purpose and regulatory conformance.
- Trend and interpret bioburden and environmental monitoring (EM) data; escalate and explain excursions; drive cross-functional actions and brief senior leadership.
- Build a value-added microbiology program aligned with quality, regulatory, and legal requirements.
- Define microbiology KPIs and dashboards; lead continuous improvement.
- Embed quality tools and formal risk management (e.g., FMEA, HACCP, fault tree analysis) across program elements.
- Proactively update strategies, procedures, and controls to remain compliant and effective.
- Make timely, science-based decisions to protect patient safety; communicate risk, rationale, and outcomes.
- Resolve complex technical challenges while harmonizing with global regulatory standards to support reliable product release.
- Serve as the drug product site’s microbiology authority and primary interface to regulators and internal/corporate partners.
- Translate program vision into executable action plans with clear owners, timelines, and success metrics.
- Ensure transparency of the Microbiological Control Strategy and engage the organization in execution.
- Lead, develop, and upskill managers and specialists; allocate resources based on priorities, risk, and business needs.
- Set high performance standards, coach teams, and enforce accountability.
Qualifications/Required:
- Bachelor’s degree in microbiology, medical technology, biology, or related field.
- Director experience in pharmaceutical/biotech industry:
- Associate Director: 10+ years
- Director: 12+ years
Preferred/Role May Be For You If You Have:
- Comprehensive knowledge of microbiological expectations across drug development, pharmaceutical technology, and drug manufacturing; knowledge of CMC and GMP; strong understanding of drug laws, global regulations, and guidelines.
- Experience building quality culture and quality management capabilities.
- Comprehensive knowledge/experience with CMC content for submissions (IND, BLA, CBE, PAS) and equivalent European submissions.
- Ability to think and operate in a rapidly evolving/ambiguous environment; strong leadership and written/oral communication.
- Intellect for quality risk identification, mitigation, and management.
Application instructions:
- Apply now to take your first step toward living the Regeneron Way.