Microbiology Manager

RK PHARMA INCTown of Orangetown, NY
Onsite

About The Position

This role is a leadership position responsible for establishing, managing, and continuously improving microbiology operations within a GMP environment. The position plays a critical role in building systems, supporting growth projects, and maintaining a state of control across microbiology, validation, and quality documentation. This role will be well-suited for an experienced microbiology leader who enjoys building programs, mentoring teams, and working cross-functionally in developing or expanding facilities. We want to be transparent: this role is best suited for someone comfortable working in a growing organization, where systems are being strengthened and built thoughtfully, rather than one that already has every structure in place.

Requirements

  • Advanced degree in Microbiology or a related scientific discipline
  • Significant experience leading microbiology operations in a GMP pharmaceutical environment
  • Strong background in microbiological testing, environmental monitoring, validation, and compliance
  • Experience establishing or strengthening microbiology quality systems
  • Comfort working in growing or evolving organizations
  • Strong documentation, audit, and regulatory readiness experience
  • Collaborative leadership style with a focus on steady execution

Nice To Haves

  • Experience supporting new facility start-ups or expansions
  • Experience leading microbiology functions across multiple sites
  • Hands-on background combined with leadership responsibilities

Responsibilities

  • Lead day-to-day microbiology operations in compliance with GMP requirements
  • Establish, implement, and maintain microbiology quality systems, SOPs, and documentation
  • Support validation and qualification activities including IQ, OQ, PQ for microbiology labs and production areas
  • Oversee environmental monitoring, water systems, sterility assurance, and contamination control programs
  • Support audit readiness, inspections, and regulatory interactions
  • Collaborate with Quality Assurance, Manufacturing, Validation, and Engineering teams
  • Support new projects, expansions, and technology implementation
  • Manage and mentor microbiology staff and contractors
  • Work with external vendors and service providers for calibration, validation, and testing activities

Benefits

  • A leadership role with real impact on systems and culture
  • The opportunity to shape microbiology operations and quality infrastructure
  • A respectful, collaborative working environment
  • Clear expectations and support from senior leadership
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