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Rapid Micro Biosystems

Posted 4 months ago

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Director, Microbiology

LexingtonOn-siteFull-time

AI Summary

The Director, Microbiology leads microbiology strategy, laboratory operations, and new product development for the Growth Direct System, driving innovation and ensuring regulatory compliance.

About this role

Winning the race to bring new healthcare products safely to a waiting world drives Rapid Micro Biosystems (RMB) to combine today’s innovative technologies as never before. Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come. The sky’s the limit.

Careers at RMB are fast-moving, with the high growth you’d expect from a world leader in microbiology automation. Advancement at RMB affords an opportunity to achieve your personal goals and develop your passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills. You’ll do more, learn more, and have the ability to make a profound impact on our business.

The Director, Microbiology provides strategic and operational leadership for microbiology research, new product development (NPD), and applications services supporting the Growth Direct® System and its applications.
This role is responsible for leading microbiology-driven innovation, overseeing laboratory operations, directing technical strategy for product development programs, and serving as a pharmaceutical microbiology subject matter expert (SME). The position partners cross-functionally with Engineering, Product Management, Operations, Quality, and Commercial teams to deliver validated, compliant, and market-ready solutions.
The Director ensures scientific rigor, regulatory compliance (GLP/GMP), portfolio prioritization, budget stewardship, and talent development while aligning microbiology initiatives with company growth objectives and customer needs.

Job Responsibilities

  • Leads microbiology strategy for new product development initiatives, including sterility testing, environmental monitoring, bioburden, and experimental applications for the Growth Direct® System.
  • Oversees day-to-day operations of the R&D microbiology laboratory, including resource planning, workflow optimization, equipment management, and budget control.
  • Directs experimental design, validation studies, and feasibility programs within GLP/GMP frameworks.
  • Provides technical leadership for growth media formulation, scale-up, and manufacturing validation.
  • Serves as a microbiology SME for cross-functional product development teams, supporting design requirements, design verification, risk assessments, and regulatory submissions.
  • Manages laboratory personnel, including hiring, performance management, mentoring, and career development.
  • Ensures compliance with safety protocols, quality systems, and laboratory best practices.
  • Oversees demo laboratory operations and customer application projects, supporting commercial growth and key account strategies.
  • Partners with Quality and Manufacturing teams to align best practices and ensure scalable, compliant solutions.
  • Reviews and approves complex technical reports, validation protocols, and study results.
  • Leads technical investigations, root cause analyses, and risk-based decision-making related to customer support activities.
  • Supports global customer engagements, technical presentations, and strategic account initiatives.
  • Drives continuous improvement initiatives focused on efficiency, cost optimization, and scientific advancement.
  • Manages laboratory inventory, capital planning, and instrument asset utilization.
  • Completes special strategic projects including competitive analysis, statistical studies, and product feasibility assessments.

    • Education

  • Bachelor’s degree in microbiology or related life science discipline required. Master’s degree preferred.

    • Work Experience

  • 10+ years of progressive experience in pharmaceutical, biotech, CRO, CDMO, or regulated laboratory environments, including leadership experience in GLP/GMP settings.

    • Technical Experience

  • Sterility testing, bioburden, and environmental monitoring
  • Rapid microbiological methods
  • Growth media formulation and validation
  • Method validation and regulatory compliance
  • Product development lifecycle in regulated environments

    • Leadership and Business Competencies

  • Portfolio prioritization and cross-functional program leadership
  • Budget management and capital planning
  • Talent development and performance management
  • Strategic thinking aligned to commercial objectives
  • Strong analytical and risk-based decision-making skills

    • Skills

    BioburdenEnvironmental MonitoringGLPGMPGrowth Media FormulationMethod ValidationProduct Development LifecycleRapid Microbiological MethodsRegulatory ComplianceSterility Testing

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