Metrology Manager

Role Summary

The Metrology Manager will be responsible for developing and leading Denali’s site-wide metrology and calibration program to support GMP manufacturing, utilities, and laboratories. This individual will ensure that all critical instruments and equipment are calibrated, traceable, and maintained in compliance with FDA, EMA, and ISO regulations. This is a key leadership role in a growing facility, responsible for building systems, processes, and a culture of excellence and reliability. The role requires a strong technical foundation in instrumentation and calibration, combined with experience managing people and programs in a GMP environment.

Responsibilities

• Establish and lead the site‚Äôs calibration program, ensuring it aligns with Denali‚Äôs Quality Systems and global GMP standards. Develop calibration and preventative maintenance schedules, methods, and documentation to ensure accuracy and compliance.
• Oversee internal and external calibration service providers, ensuring adherence to Denali‚Äôs procedures and timelines.
• Maintain the site‚Äôs calibration maintenance management system (CMMS) to ensure complete traceability and data integrity.
• Ensure all calibration activities comply with applicable regulatory standards (21 CFR Parts 210, 211, 820; ISO 17025; EU GMP Annex 1). Support internal and external audits, including FDA, EMA, and partner inspections.
• Investigate calibration out-of-tolerance (OOT) conditions, perform root cause analysis, and drive CAPA implementation.
• Collaborate with Quality Assurance and Validation to support change control, risk assessments, and qualification activities.
• Supervise and mentor a team of calibration technicians and/or engineers.
• Develop training plans to ensure technical proficiency and GMP awareness.
• Build a high-performance team culture centered on safety, accountability, and continuous improvement.
• Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.
• Partner with Facilities, Engineering, Manufacturing, and Quality to ensure equipment readiness and reliability. Provide metrology expertise for new equipment installations, commissioning, and qualification (IQ/OQ/PQ). Participate in process improvement initiatives and technical investigations across the facility.

Qualifications

• Bachelor‚Äôs degree in Engineering, Instrumentation, Metrology, or a related technical field required.
• Significant calibration or instrumentation experience in a GMP-regulated biopharmaceutical or medical device environment.
• 3+ years in a leadership or supervisory capacity.
• Experience implementing and maintaining calibration programs during site startup or facility expansion preferred.
• Strong understanding of calibration standards, instrumentation principles, and metrology best practices.
• Experience with computerized calibration management systems (e.g., Blue Mountain, ProCal, Maximo).
• Familiarity with bioprocess equipment (bioreactors, temperature controlled units, CIP/SIP systems, autoclaves, utility systems).
• Knowledge of relevant regulatory standards and audit expectations.

Skills

• Strong communication, organization, and problem-solving skills.
• Ability to thrive in a fast-paced, startup-like environment with evolving processes and priorities.
• Integrity, collaboration, and scientific rigor.

Education

• Bachelor‚Äôs degree in Engineering, Instrumentation, Metrology, or a related technical field.

Additional Requirements

• Role is on-site Monday-Friday at Denali‚Äôs Salt Lake City GMP Manufacturing Facility.
• May require off-hours or weekend work to support production and qualification schedules.