Director of Operations

Flow Control GroupNorthampton, MA

About The Position

As Director of Operations, you will lead and oversee all operational, strategic, and financial aspects of Purity One. This is a hands-on leadership role requiring a seasoned professional with deep experience in life sciences or biopharmaceutical manufacturing. You will ensure operational excellence, foster a high-performance team, and drive sustainable business growth.

Requirements

  • Industry Experience: Extensive (typically 7–10+ years) leadership in life sciences, biotech, or pharmaceutical manufacturing with cleanroom or single-use solution environments.
  • Hands-On Leadership: A leader with proven ability to be deeply involved in daily operations, able to troubleshoot, motivate, and inspire teams.
  • Regulatory Knowledge: Solid understanding of ISO 13485, GMP, cleanroom standards, and quality systems.
  • Operational Excellence: Experience implementing lean manufacturing or continuous improvement methodologies.
  • Commercial Acumen: Strong analytical skills, financial insight, and customer-focused sensibility.
  • Communication & Culture: Excellent interpersonal and communication skills to foster alignment, teamwork, and high performance.
  • Education: Bachelor's degree in Engineering, Life Sciences, Operations, or related field; advanced degree preferred.
  • Leadership Track Record: Demonstrated success in managing multi-disciplinary teams and operational budgets.
  • Compliance Expertise: Familiarity with quality systems and certifications relevant to biopharma manufacturing.

Nice To Haves

  • Lean or Six Sigma certification
  • Cleanroom management experience

Responsibilities

  • Operational Leadership: Direct all aspects of cleanroom manufacturing, assembly, supply chain, and quality operations to uphold Purity One’s standards of precision and GMP compliance.
  • Strategic Planning: Develop and execute business strategies to achieve financial targets, expand capabilities, and increase market penetration—especially in life sciences and biotech sectors.
  • People & Team Management: Lead, mentor, and empower cross-functional teams (production, quality, engineering, supply chain) to promote accountability, efficiency, and collaboration.
  • Quality & Compliance: Safeguard strict adherence to ISO 13485, cleanroom protocols, and regulatory standards.
  • Supplier & Customer Engagement: Nurture strategic supplier relationships and direct customer interactions to optimize responsiveness and solution delivery.
  • Continuous Improvement: Implement lean workflows, operational excellence initiatives, and data-driven KPIs (quality, throughput, cost) to support scalable growth.
  • Financial Oversight: Manage budgeting, cost control, profitability, and resource allocation to optimize ROI.
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