Director, QA Microbiology (Drug Product Manufacturing)

Regeneron Pharmaceuticals • Rensselaer, NY

2d • Onsite

About The Position

We are currently looking to fill a Director QA Microbiology position. This position drive the continuous improvement of contamination control and sterility assurance programs at Regeneron’s Drug Product Fill/Finish site. This role strengthens practices and procedures that safeguard product sterility, assesses and implements new technologies to enhance patient safety, and maintains a robust facility bioburden and sterility strategy, including remediation when needed. The position also supports inspection readiness, presents on microbiology topics during partner and regulatory inspections, and contributes to the goal of zero regulatory observations. In this role, a typical day might include the following: 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 to ensure fitness for purpose and regulatory conformance. Trend and interpret bioburden and EM data, escalate and explain excursions, and drive cross-functional actions; brief senior leadership on impact and status. Build a value-added microbiology program anchored in sound science and aligned with applicable quality, regulatory, and legal requirements. Define meaningful microbiology KPIs and dashboards to monitor performance and lead continuous improvement. Embed quality tools and formal risk management (e.g., FMEA, HACCP, fault tree analysis) across program elements to inform decisions. Anticipate changing expectations and proactively update strategies, procedures, and controls to remain compliant and effective. Make timely, science-based decisions that protect patient safety; communicate risk, rationale, and outcomes transparently. Resolve complex technical challenges while harmonizing with global regulatory standards to enable reliable product release and supply continuity. Decide with confidence under pressure and influence internal and external partners to achieve acceptable outcomes. Serve as the drug product site’s microbiology authority and primary interface to regulators, internal teams, and corporate partners on microbiological topics. Translate program vision and business strategy into executable action plans with clear owners, timelines, and success metrics. Ensure transparency of the Microbiological Control Strategy and engage the organization in its execution. Lead, develop, and upskill a team of managers and specialists to actively add value to various workstreams within the internal fill finish workstreams. Allocate resources in line with program priorities, risk, and business needs. Set high performance standards, coach teams, and enforce accountability to meet microbiological and organizational objectives This role may be for you if you: Comprehensive knowledge of microbiological expectations throughout drug development process, pharmaceutical technology, drug manufacturing processes and related issues, drug laws, global regulations, and guidelines, particularly CMC and GMP. Experience building up a quality culture and quality management capabilities. Comprehensive knowledge and experience in CMC section content for investigational and marketed product submissions (IND, BLA, CBE, PAS) for FDA and equivalent submissions for Europe. A sense of passion and commitment for delivering things as quickly and efficiently as possible. The ability to think and operate in a rapidly evolving and ambiguous environment. Ability to articulate and execute concepts for developing and ensuring the highest quality throughout the network (internal and external). Intellect for quality risk identification, mitigation, and management. Strong leadership and communication skills —written and oral. Experience with businesses in different phases of the business lifecycle and the quality and validation issues associated with these phases.

Requirements

• Comprehensive knowledge of microbiological expectations throughout drug development process, pharmaceutical technology, drug manufacturing processes and related issues, drug laws, global regulations, and guidelines, particularly CMC and GMP.
• Experience building up a quality culture and quality management capabilities.
• Comprehensive knowledge and experience in CMC section content for investigational and marketed product submissions (IND, BLA, CBE, PAS) for FDA and equivalent submissions for Europe.
• A sense of passion and commitment for delivering things as quickly and efficiently as possible.
• The ability to think and operate in a rapidly evolving and ambiguous environment.
• Ability to articulate and execute concepts for developing and ensuring the highest quality throughout the network (internal and external).
• Intellect for quality risk identification, mitigation, and management.
• Strong leadership and communication skills —written and oral.
• Experience with businesses in different phases of the business lifecycle and the quality and validation issues associated with these phases.
• To be considered for this role you must hold a Bachelor’s degree in microbiology, medical technology, biology or related field and the following amount of related experience in the pharmaceutical or biotech industries, for each level: Associate Director – 10+ years Director – 12+ years

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 to ensure fitness for purpose and regulatory conformance.
• Trend and interpret bioburden and EM data, escalate and explain excursions, and drive cross-functional actions; brief senior leadership on impact and status.
• Build a value-added microbiology program anchored in sound science and aligned with applicable quality, regulatory, and legal requirements.
• Define meaningful microbiology KPIs and dashboards to monitor performance and lead continuous improvement.
• Embed quality tools and formal risk management (e.g., FMEA, HACCP, fault tree analysis) across program elements to inform decisions.
• Anticipate changing expectations and proactively update strategies, procedures, and controls to remain compliant and effective.
• Make timely, science-based decisions that protect patient safety; communicate risk, rationale, and outcomes transparently.
• Resolve complex technical challenges while harmonizing with global regulatory standards to enable reliable product release and supply continuity.
• Decide with confidence under pressure and influence internal and external partners to achieve acceptable outcomes.
• Serve as the drug product site’s microbiology authority and primary interface to regulators, internal teams, and corporate partners on microbiological topics.
• Translate program vision and business strategy into executable action plans with clear owners, timelines, and success metrics.
• Ensure transparency of the Microbiological Control Strategy and engage the organization in its execution.
• Lead, develop, and upskill a team of managers and specialists to actively add value to various workstreams within the internal fill finish workstreams.
• Allocate resources in line with program priorities, risk, and business needs.
• Set high performance standards, coach teams, and enforce accountability to meet microbiological and organizational objectives

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Director