Senior Director, Microbiology

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $221k - $286k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1987

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Gilead Sciences is a leading biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapeutics for patients with life-threatening diseases. The company is highly recognized for its contributions in virology, particularly HIV and hepatitis, and is actively expanding its therapeutic reach into fields like oncology and inflammation. Gilead has a strong pipeline of medicines, with over 25 products available globally and 50 clinical programs. Known for its commitment to health equity, the company also actively funds HIV research and causes. Gilead's dedication to scientific innovation and health equity aims to tackle the world's most pressing health challenges, improving patient lives globally.

📋 Description

• Establish and execute the enterprise microbiology and sterility assurance strategy aligned with corporate quality, manufacturing, and business objectives • Develop and maintain the global governance framework for microbiology, contamination control, and sterility assurance programs across manufacturing sites and external manufacturing partners • Define global microbiological and sterility assurance standards, technical policies, procedures, and best practices • Serve as executive subject matter expert and advisor to senior leadership on microbiological risk, contamination control, sterility assurance, and regulatory expectations • Drive enterprise initiatives focused on operational excellence, scientific innovation, and digital transformation • Provide strategic oversight of enterprise Contamination Control Strategies in accordance with EU GMP Annex 1 and global regulatory expectations • Oversee cleanroom design, classification, qualification, airflow visualization, HVAC systems, personnel qualification, gowning programs, material and personnel flows, and contamination prevention • Ensure scientifically justified, risk-based, globally harmonized environmental monitoring, utility monitoring, aseptic process simulation, and contamination control programs • Lead enterprise microbial risk assessments and contamination investigations • Provide strategic oversight of microbiology laboratory operations, including environmental monitoring, sterility testing, bioburden testing, bacterial endotoxin testing, microbial identification, mycoplasma testing, antimicrobial effectiveness testing, rapid microbiological methods, method validation and verification, and method lifecycle management • Ensure laboratory programs maintain scientific integrity, data integrity, and regulatory compliance while promoting automation, analytics, and emerging technologies • Ensure compliance with FDA, EMA, MHRA, WHO, PIC/S, ICH, ISO, USP, EP, and other global regulatory requirements • Provide executive oversight for deviations, investigations, CAPAs, change controls, quality risk assessments, validation strategies, and technical justifications • Represent the organization during regulatory inspections, customer audits, due diligence activities, and health authority inspections • Support regulatory submissions, product filings, agency responses, and post-market commitments with microbiological expertise • Monitor evolving regulatory expectations and implement improvements across the enterprise • Lead scientific evaluations of microbiological events, contamination investigations, environmental monitoring excursions, sterility and aseptic processing simulation failures, utility excursions, and product impact assessments • Establish microbial trending strategies using statistical analysis and predictive analytics • Collaborate with Global Manufacturing, Quality Operations, Facilities, Engineering, Validation, Technical Development, Supply Chain, Procurement, and Regulatory Affairs • Support facility design and expansion projects, technology transfers, new product introductions, manufacturing robustness, supplier microbiological controls, and contamination prevention across the product lifecycle • Lead a global microbiology organization focused on scientific excellence, operational performance, and continuous improvement • Develop technical capability through mentorship, coaching, succession planning, training programs, and technical development • Foster quality, accountability, innovation, and inspection readiness • Lead matrixed global teams and influence technical decision-making across business units and manufacturing sites

🎯 Requirements

• Bachelor’s degree with 14+ years of experience or PhD, MS, or equivalent advanced degree with 12+ years of experience in Microbiology, Molecular Biology, Biological Sciences, or related scientific discipline • Minimum of 12+ years of progressive experience in pharmaceutical microbiology, sterility assurance, or contamination control within regulated pharmaceutical, biologics, biotechnology, or medical device environments • Extensive experience supporting global sterile manufacturing operations and aseptic processing • Expertise in FDA, EMA, MHRA, WHO, and other global GMP regulations • Expertise in EU GMP Annex 1 • Expertise in USP microbiology chapters • Expertise in ICH Quality Guidelines • Expertise in ISO microbiological standards • Expertise in Quality Risk Management (ICH Q9) • Expertise in Pharmaceutical Quality Systems (ICH Q10) • Expertise in aseptic processing • Expertise in Contamination Control Strategy development • Proven success leading regulatory inspections and executive interactions with global health authorities • Demonstrated leadership with large, complex, global matrixed organizations • Executive leadership experience desired • Experience implementing Rapid Microbiological Methods and microbiology laboratory automation preferred • Experience supporting ATMPs, cell and gene therapy, vaccines, biologics, or combination products preferred • Board certification or professional certification through recognized microbiology or quality organizations preferred • Experience implementing digital laboratory platforms, predictive analytics, and data visualization tools preferred • Lean, Six Sigma, Operational Excellence, or equivalent continuous improvement training preferred

🏖️ Benefits

• Discretionary annual bonus • Discretionary stock-based long-term incentives • Paid time off • Company-sponsored medical insurance • Company-sponsored dental insurance • Company-sponsored vision insurance • Company-sponsored life insurance