Director of Operations
Purity One™, Inc. · Northampton, MA · 1 wk ago
ManagementFull-time
Key Responsibilities
- Direct all aspects of cleanroom manufacturing, assembly, supply chain, and quality operations to uphold Purity One’s standards of precision and GMP compliance.
- Develop and execute business strategies to achieve financial targets, expand capabilities, and increase market penetration—especially in life sciences and biotech sectors.
- Lead, mentor, and empower cross-functional teams (production, quality, engineering, supply chain) to promote accountability, efficiency, and collaboration.
- Safeguard strict adherence to ISO 13485, cleanroom protocols, and regulatory standards.
- Nurture strategic supplier relationships and direct customer interactions to optimize responsiveness and solution delivery.
- Implement lean workflows, operational excellence initiatives, and data-driven KPIs (quality, throughput, cost) to support scalable growth.
- Manage budgeting, cost control, profitability, and resource allocation to optimize ROI.
Ideal Candidate Profile
- Extensive (typically 7–10+ years) leadership in life sciences, biotech, or pharmaceutical manufacturing with cleanroom or single-use solution environments.
- A leader with proven ability to be deeply involved in daily operations, able to troubleshoot, motivate, and inspire teams.
- Solid understanding of ISO 13485, GMP, cleanroom standards, and quality systems.
- Experience implementing lean manufacturing or continuous improvement methodologies.
- Strong analytical skills, financial insight, and customer-focused sensibility.
- Excellent interpersonal and communication skills to foster alignment, teamwork, and high performance.
Qualifications & Education
- Bachelor's degree in Engineering, Life Sciences, Operations, or related field; advanced degree preferred.
- Demonstrated success in managing multi-disciplinary teams and operational budgets.
- Familiarity with quality systems and certifications relevant to biopharma manufacturing.
- Preferred: Lean or Six Sigma certification; cleanroom management experience.