Metrology Lab Lead - Calibration & Compliance

Bora Pharmaceuticals; Maple Grove (MN); On-site; USD 88,000 - 115,000; Full time

Benefits offered by this job

Salary & incentives

Health insurance

Retirement plan

Paid time off

Professional development

Wellness programs

Employee assistance

Job summary

Bora Pharmaceuticals, a premier CDMO, seeks a Metrology Supervisor to lead the Calibration and Instrumentation group. You will ensure calibration, qualification, maintenance, and compliance of laboratory and manufacturing equipment.

You will provide strategic direction and mentorship to the team to uphold cGMP standards. The role involves coordinating with Quality and senior management, managing calibration data reviews, and driving process improvements.

Qualifications

• Bachelor's degree with minimum 5 years' pharma industry experience OR Master's degree with minimum 3 years' experience in pharma.
• Analytical chemistry knowledge.
• Experience working in a laboratory environment, preferably pharma.
• Leadership experience preferred.
• Experience with metrology preferred.

Responsibilities

• Provides leadership to the Metrology team, including staff development and coaching.
• Demonstrates mentoring and professional development for direct reports.
• Maintains strong communication within Bora and across the organization.
• Maintains effective written and verbal communication in meetings and via documentation.
• Serves as subject matter expert for instrumentation and cGMP compliance.
• Plans instrument/equipment, maintenance and calibration activities to support end users.
• Develops, implements and monitors SOPs and calibration procedures; ensures cGMP compliance.
• Communicates calibration results and deviations to Quality and senior management.
• Coordinates with outside vendors and 3rd party labs for calibration results.
• Evaluates Metrology systems and processes; drives efficiency and cost savings.
• Participates in FDA, customer and internal audits and responds to deficiencies.
• Reviews departmental budget and approves expenditures as necessary.

Skills

Analytical chemistry knowledge

Leadership

Metrology experience

Education

Bachelor's degree in chemistry or engineering or related science with 12 credits chemistry

Master's degree in chemistry or engineering

Job description

Bora Pharmaceuticals, a premier CDMO, seeks a Metrology Supervisor to lead the Calibration and Instrumentation group. You will ensure calibration, qualification, maintenance, and compliance of laboratory and manufacturing equipment.

You will provide strategic direction and mentorship to the team to uphold cGMP standards. The role involves coordinating with Quality and senior management, managing calibration data reviews, and driving process improvements.