Senior Calibration Technician

Ask Bio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease.

Ask Bio’s gene therapy platform includes Pro
10, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

Our vision:
Pioneering science to create transformative molecular medicines.

Our mission:
Lead innovative science and drive clinical outcomes to transform people's lives.

Our principles:

Advance innovative science by pushing boundaries.

Bring transformative therapeutics to patients in need.

Provide an environment for employees to reach their fullest potential.

Our values:

Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.

Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.

Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.

Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.

Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.

Position Summary The Sr. Calibration Technician performs advanced calibration, testing, troubleshooting, and maintenance of precision instruments and equipment supporting manufacturing, research, and quality control operations. This experienced individual-contributor role provides technical guidance to other technicians, develops calibration procedures, and collaborates with Quality, Validation, Engineering, and Operations teams to maintain accurate, compliant, and reliable instrumentation.

This is an onsite position based in RTP, NC. The position will report to the Manager, Calibration and Instrumentation.

Job Responsibilities Advanced Calibration:
Perform and oversee calibration of critical instruments and systems (e.g., temperature controllers, pressure transducers, pH meters, analytical balances, bioreactors, and HVAC systems) to ensure accuracy and compliance with pharmaceutical standards

Team Leadership:
Train, and mentor calibration technicians (Levels I and II), ensuring consistent execution of calibration procedures and adherence to Good Manufacturing Practices (GMP)
Regulatory Compliance:
Ensure all calibration activities comply with FDA regulations (21 CFR Part 11), GMP, ISO 17025, and other relevant standards, maintaining audit-ready documentation

Procedure Development:
Develop, validate, and update calibration procedures and protocols, ensuring alignment with USP, ICH guidelines, and manufacturer specifications

Troubleshooting and Maintenance:
Diagnose and resolve complex issues with process and laboratory equipment, performing or overseeing repairs to maintain compliance and operational efficiency

Documentation and Reporting:
Maintain detailed calibration records, generate Certificates of Calibration, and ensure documentation meets regulatory requirements for audits and inspections

Quality Assurance:
Verify calibration results against standards, investigate out-of-tolerance conditions, and implement corrective actions to ensure product quality and compliance

Calibration Program Management:
Develop and manage calibration schedules, prioritize tasks, and coordinate with operations and quality teams to minimize downtime in manufacturing and laboratory environments

Equipment Oversight:
Maintain and calibrate reference standards, manage calibration tools, and ensure proper storage and handling of equipment in cleanroom and controlled environments

Collaboration:

Partner with quality…