Manager, Calibration and Instrumentation

Asklepios BioPharmaceutical, Inc. (AskBio) • Durham, NC

7d

About The Position

AskBio 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. AskBio’s gene therapy platform includes Pro10™, 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.

Requirements

• Bachelor’s degree in facilities management or related field
• 6+ years’ experience in managing calibration and instrumentation teams
• 5+ years’ experience in GxP laboratories and facilities
• A proven track record of solving problems methodically and efficiently
• Ability to create clear process maps, work instructions, job plans and procedures
• Strong collaborative skills with the ability to influence across multiple departments

Nice To Haves

• Strong Operational Excellence foundation with applicable certifications (e.g., CMRP, Six-Sigma)
• Calibration and/ or Instrumentation Certification

Responsibilities

• Maintain and build upon a culture of safety and compliance by ensuring adherence to and continuous improvement of all related procedures and policies
• Manage quality records (Change Controls, SOPs, Deviations, CAPAs, Training) related to scientific facility and equipment operations, driving efforts to standardize quality operations within the team
• Accountable for the development, budget, and compliance of the site’s metrology and calibration program, managing the internal calibration team and contractors
• Collaborate with research teams to align facility services with team needs and support the development of SMEs within the team
• Create and control budget for calibration and instrument services
• Balance in-house work with contracted work by using sound financial analysis
• Manage, negotiate, and maintain vendor contracts, service level agreements (SLAs), and the budget for all scientific equipment, instruments, and related services
• Act as a Subject Matter Expert (SME) to optimize the CMMS configuration and workflows specifically for laboratory asset management and calibration activities
• Apply operational excellence principles to the management of assets from onboarding to retirement to drive value for AskBio

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 251-500 employees