Associate Director, Facilities Reliability

at  Asklepios BioPharmaceutical

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.
At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.
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.

About the role
Reporting to the Director of Facility Operations, the Associate Director of Facility Reliability will be responsible for ensuring that all facility operations adhere to the highest standards of quality and compliance with regulatory requirements. You will establish and oversee processes related to facility operations as they relate to equipment validation and management, regulatory compliance, and continuous improvement initiatives to maintain a safe and compliant working environment.

Responsibilities & Accountabilities

• Lead all aspects of personnel management for direct reports to include developing a staffing strategy that is consistent with overall organizational needs and objectives, recruitment of appropriate team members, performance management, development, and retention of team members.
• Manage, monitor, and develop streamlined preventive maintenance and calibration programs to ensure all activities are completed based on predetermined maintenance schedules. Maintain all records and reports according to GXP requirements.
• Position will act as Business administrator and owner of the Computerized Maintenance Management System (CMMS) for facility and lab environments. You will work closely with the facility and lab operations teams to develop, prioritize, and implement detailed maintenance schedules for all equipment and facilities, in addition to providing process summaries and process adherence KPIs for completed and scheduled maintenance activities.
• Business administrator and owner of other engineering business and compliance systems as required.
• Review, assign and oversee all equipment troubleshooting and on-demand repairs to support facility and laboratory activities. Work with staff to quickly identify and resolve issues to minimize downtime while maintaining compliance with SOPs and regulatory expectations.
• Development and reporting of KPIs for the Facilities and Engineering team.
• Develop asset records to ensure accuracy of equipment information, appropriate maintenance routine and spare parts assessment.
• Work with inter-departmental groups to develop, implement, and maintain Facility and Engineering programs to ensure proper control and organization. For example, Parts Inventory, Spare Key and Peer Review programs.
• Participate in client and regulatory audits, audit responses and follow-up corrective actions as required.
• Ensure equipment and facility maintenance and calibration records are always maintained according to audit-ready status.
• Develop, coordinate, and execute strategies related to equipment relocation, modification, and updates, ensuring GMP compliance by working with team leaders including validation, engineering, asset owners and quality assurance.
• Conduct weekly planning meetings with the planner scheduler, rescheduling and reassigning tasks as needed.
• Ensure the timely initiation and completion of facility deviations, change controls and CAPAs related to Facilities systems. Implement effective practices related to change control task management, investigation best practices, root cause analysis, and corrective actions to ensure high quality output of department-owned QMS records.
• Generate or revise SOPs as required for updated systems and procedures.
• Generate, revise, deliver, and/or assign training as needed.

About you

Requirements

• Bachelor’s degree in engineering (mechanical, electrical, or related field) and 7+ years’ relevant experience in facilities management position
• Strong technical knowledge of mechanical, electrical, plumbing, HVAC, building automation, and safety systems
• 2+ years’ prior leadership experience
• Strong understanding of laboratory safety protocols and compliance standards
• Excellent organizational and leadership skills to effectively manage a diverse team
• Proficiency in budget management and resource allocation
• Knowledge of scientific equipment and maintenance procedures
• Strong problem-solving ability and adaptability to address facility-related challenges
• Effective communication skills to interact with researchers, staff, and external partners
• Comfortable in a fast-paced, collaborative small-company environment, working with minimal direction and able to adjust workload based upon changing priorities

Preferred Skills & Experience

• MS/MBA degree and/or advanced technical certifications (PE, PMP, FMA, Lean Six Sigma)
• Building operations or facility management experience in the biotechnology or pharmaceutical industry. Instrumentation, metrology, and/or equipment and computer system validation experience
• Prior experience supporting laboratory and GXP facility operations with a proven track record for success in implementing Quality-based requirements into Facilities department processes. Experience within multiple quality phase environments (GMP, GLP, GCP, R&D, CLIA, etc.)

Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at
careers@askbio.com.
Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency

• Lead all aspects of personnel management for direct reports to include developing a staffing strategy that is consistent with overall organizational needs and objectives, recruitment of appropriate team members, performance management, development, and retention of team members.
• Manage, monitor, and develop streamlined preventive maintenance and calibration programs to ensure all activities are completed based on predetermined maintenance schedules. Maintain all records and reports according to GXP requirements.
• Position will act as Business administrator and owner of the Computerized Maintenance Management System (CMMS) for facility and lab environments. You will work closely with the facility and lab operations teams to develop, prioritize, and implement detailed maintenance schedules for all equipment and facilities, in addition to providing process summaries and process adherence KPIs for completed and scheduled maintenance activities.
• Business administrator and owner of other engineering business and compliance systems as required.
• Review, assign and oversee all equipment troubleshooting and on-demand repairs to support facility and laboratory activities. Work with staff to quickly identify and resolve issues to minimize downtime while maintaining compliance with SOPs and regulatory expectations.
• Development and reporting of KPIs for the Facilities and Engineering team.
• Develop asset records to ensure accuracy of equipment information, appropriate maintenance routine and spare parts assessment.
• Work with inter-departmental groups to develop, implement, and maintain Facility and Engineering programs to ensure proper control and organization. For example, Parts Inventory, Spare Key and Peer Review programs.
• Participate in client and regulatory audits, audit responses and follow-up corrective actions as required.
• Ensure equipment and facility maintenance and calibration records are always maintained according to audit-ready status.
• Develop, coordinate, and execute strategies related to equipment relocation, modification, and updates, ensuring GMP compliance by working with team leaders including validation, engineering, asset owners and quality assurance.
• Conduct weekly planning meetings with the planner scheduler, rescheduling and reassigning tasks as needed.
• Ensure the timely initiation and completion of facility deviations, change controls and CAPAs related to Facilities systems. Implement effective practices related to change control task management, investigation best practices, root cause analysis, and corrective actions to ensure high quality output of department-owned QMS records.
• Generate or revise SOPs as required for updated systems and procedures.
• Generate, revise, deliver, and/or assign training as needed