Sr Director, Microbiology

Responsibilities

• Establish and execute enterprise microbiology strategy aligned with business objectives
• Develop global governance for microbiology and sterility assurance across manufacturing sites
• Define microbiological standards and policies for consistent implementation
• Advise senior leadership on microbiological risks and regulatory expectations
• Oversee enterprise contamination control strategies under EU GMP Annex 1
• Lead microbial risk assessments and contamination investigations
• Collaborate across functions to improve manufacturing robustness and contamination prevention

Qualifications

• Bachelor's degree with 14+ years of experience, or an advanced degree (PhD, MS) with 12+ years in Microbiology or a related field
• 12+ years of progressive experience in pharmaceutical microbiology and sterility assurance
• Extensive experience with global sterile manufacturing and aseptic processing
• Expertise in global GMP regulations, including FDA, EMA, and ICH guidelines
• Success leading regulatory inspections and executive interactions with health authorities

Pay

$221,000 – $286,000 annually

Schedule

Remote - US based candidates only, no visa sponsorship available

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans
• Paid time off and eligibility for a discretionary annual bonus
• Discretionary stock-based long-term incentives
• Comprehensive benefits package that supports employee well-being