About Bora:
Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from First‑in‑Human through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purpose‑built for commercialization. Our inspection‑proven, bi‑coastal U.S. manufacturing platform and integrated development center provide the infrastructure, regulatory discipline, and operational precision required for sustained global market supply.
Job Summary:
The Senior Manager, Metrology provides strategic and operational leadership for the site calibration and metrology program at Bora Biologics. This role is accountable for establishing, maintaining, and continuously improving a compliant, reliable, and efficient calibration program supporting manufacturing equipment, laboratory instrumentation, and utility systems. The position serves as the business and system owner for BMRAM and ensures calibration activities and associated records meet cGMP, quality, safety, and applicable regulatory requirements. The Senior Manager provides leadership and technical oversight for calibration employees and contractors and ensures appropriate staffing, training, scheduling, and performance of the function. The role provides oversight of instrumentation lifecycle activities and partners with equipment owners to maintain the compliant state of calibrated assets. This position collaborates closely with Facilities, Engineering, Quality, Manufacturing, and other stakeholders to ensure instrumentation reliability and support site operational objectives.
Essential Functions:
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Provide leadership and technical oversight of the site calibration program, establishing standards, procedures, and best practices to ensure calibration activities are performed in accordance with cGMP requirements, approved procedures, quality standards, and applicable regulatory requirements.
• Manage, motivate, and mentor calibration staff; organize and prioritize workload, ensure appropriate training, promote teamwork, and drive achievement of productivity goals and continuous improvement.
• Serve as business and system owner for BMRAM, ensuring data integrity, timely and accurate entry of calibration records, appropriate management and notification of Out of Tolerance conditions, approval of calibration activities, monitoring and reporting of due and overdue activities, and ongoing system administration in partnership with IT.
• Coordinate and schedule calibration and preventive maintenance activities for manufacturing equipment, laboratory instrumentation, and utility systems.
• Provide technical and operational oversight of calibration contractors and service providers, ensuring personnel are appropriately qualified and work is performed in accordance with approved procedures, quality requirements, contractual expectations, and established budgets.
• Support procurement, setup, and lifecycle management of instrumentation and partner with internal instrument owners to ensure Equipment/Instrument Master Files are generated and maintained.
• Lead the investigation and resolution of complex calibration and instrumentation issues, including cross-functional problems and Out of Tolerance conditions, and identify appropriate corrective and preventive actions to minimize recurrence and operational impact.
• Implement continuous improvement and operational excellence methods and tools to improve the efficiency and effectiveness of calibration operations.
• Collaborate effectively with Facilities, Engineering, Quality, Manufacturing, and other internal customers to ensure proper functionality of instrumentation and support projects, policies, and procedures.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of…