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Facilities Manager
Watertown, MA
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Description
Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases. Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery. LYR-210 is designed for surgically naïve patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial. These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year.


Our team is growing, and we are currently recruiting a Facilities Manager to join our dynamic team. This role presents a unique opportunity to leverage past experience and skills to the construction of a cutting-edge commercial GMP manufacturing facility from the ground up.


The Facilities Manager will be responsible for ensuring the functionality, safety, and efficiency of Lyra’s facilities, equipment, and utilities, in particular of our new GMP pharmaceutical manufacturing facility. They will manage the seamless operation, maintenance, and compliance of all facility-related systems and procedures, maintenance program of all equipment, direct building projects, manage vendor relationships, support commissioning & qualification activities, oversee budgets, and ensure facility-wide compliance with safety and regulatory standards.


Responsibilities

  • Oversee day-to-day operations and maintenance of the manufacturing facility, including equipment, utilities, and infrastructure to ensure systems are running reliably, efficiently and in compliance with current Good Manufacturing Practices (cGMP)
  • Develop and implement preventative maintenance programs for critical equipment and utilities. Write and execute maintenance job plans for routine or scheduled maintenance tasks on various equipment to ensure that maintenance tasks are performed consistently and efficiently, reducing downtime and improving the reliability and longevity of our equipment
  • Coordinate with internal teams and external contractors to ensure smooth execution of facility-related capital projects and renovations
  • Manage budgeting and forecasting for facility operations, ensuring cost-effectiveness and efficiency
  • Ensure compliance with safety, health, and environmental regulations, and maintain documentation as required. Write and execute emergency preparedness plans
  • Establish and maintain relationships with building owners, external contractors, service providers, and suppliers to ensure high-quality services. Negotiate contracts and service agreements as needed for technical suitability and cost-effectiveness
  • Establish and implement facility policies, SOPs, and best practices
  • Collaborate with cross-functional teams to support manufacturing goals and objectives
  • Respond promptly to emergency situations or disruptions, coordinating repairs and minimizing downtime
  • Support commissioning and qualification activities related to the construction of a new commercial manufacturing site
  • Support the development, implementation, and operation of various Facilities related computer systems such as Enterprise Asset Management (EAM) system, Computerized Maintenance Management System (CMMS), Computerized Calibration Management System (CCMS), Building Management System (BMS), and Environmental Management System (EMS)
Requirements
  • Bachelor’s degree in Facilities Management, Engineering, or related field
  • A minimum of 5 years' experience in facilities management, preferably in the biotech, medical device, or pharmaceutical industry
  • Strong understanding of GMP and safety regulations related to a manufacturing facility
  • Proven ability to manage budgets and resources effectively
  • Excellent project management skills, with the ability to handle multiple projects simultaneously
  • Strong communication and leadership skills
  • Exceptional problem-solving skills, adaptability, and an ability to work under pressure

At Lyra, we value creativity, leadership, and collaboration.  The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable.  We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team.  For consideration, please submit cover letter and CV.

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