Microbiology Manager in Pearl River, New York at RK PHARMA INC

Who We Are

RK Pharma is a pharmaceutical organization focused on developing and manufacturing high-quality, affordable drug products through disciplined execution and strong internal collaboration. We operate in regulated environments where quality, consistency, and sound judgment matter every day.

We value people who do careful work, build strong systems, and take pride in establishing processes that hold up over time — not just during inspections.

About the Role

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.

Key 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

What We’re Looking For

Required

• 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

Preferred

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

Important Context (Please Read Carefully)

RK Pharma is a growing organization. While this role offers meaningful leadership scope and impact, candidates should be comfortable with no relocation support at this time, evolving organizational structures, and a deliberate pace of growth focused on long-term stability rather than short-term incentives.

We believe in being honest upfront so that this role works well for both the individual and the organization.

How We Work

At RK Pharma, quality comes before speed. We value clear communication, early escalation, and disciplined decision-making. Leaders here are expected to build calm, reliable systems and support teams without creating unnecessary urgency or hierarchy.

People who are successful here tend to be steady, thoughtful, and confident in building strong foundations.

What We Offer

• 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

Equal Opportunity Employer
RK Pharma is an equal opportunity employer committed to fair, consistent, and respectful hiring practices.