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. For more information, please visit www.lyratherapeutics.com and follow us on LinkedIn and Twitter.

Our team is growing and we are currently seeking a hands-on Facilities Director to oversee all activities related to facilities, maintenance, calibration and safety. The successful candidate must have 15 or more years’ previous experience in supporting a biotechnology/medical device start-up environment with laboratory and GMP manufacturing cleanroom areas.  The ideal candidate will thrive in a fast-paced environment, and be motivated by the opportunity to learn new technologies.

Responsibilities

• Develop and own a strategic facilities plan, proactively addressing future space constraints and operational challenges, and managing transitions to future locations
• Assist with lab design and GMP manufacturing plant design, and liaise with the architecture and construction firms. Manage planning and execution of capital investments in facility infrastructure and equipment
• Lead the design, installation, maintenance and operation of Facilities systems and procedures, including GMP and non-GMP utilities, waste systems, and HVAC
• Build and manage equipment maintenance, metrology, security access, and pest control programs
• Direct and manage employees and contracted services as needed 
• Full responsibility for the safe, clean, compliant and efficient operation of the GMP manufacturing facility systems 
• Manage comprehensive Environmental, Health & Safety programs and processes, including hazardous materials management
• Support facility CAPEX and OPEX budgeting, and resource prioritization
• Develop scope of projects, user requirements, specifications, create requests for proposals (RFP’s), evaluate statement of work and cost proposals, contracts, project management requirements
• Coordinate the development, implementation, and preservation of key standard operating procedures and policies appropriate for a GMP drug/device combination product 
• Participate in company risk management processes, develop, and implement business continuity planning for plant, laboratory and office (including any evolution of COVID-19 plans in collaboration with the Leadership Team)
• Maintain local and state government documentation requirements relating to facilities and operations, ensure compliance with all applicable health and safety laws and regulations, Maintain all pertinent permitting

• Bachelor’s degree in sciences, engineering, or business administration or equivalent experience
• Minimum 15 years’ experience in Biotech/Pharma, including 8+ years in GMP Facilities management, with a technical background preferred (mechanical engineering, mechanical engineering technology, or scientific operations)
• Previous management experience with strong leadership skills and a focus on talent development and team building
• Demonstrated knowledge of regulations concerning pharmaceutical facilities, chemical labs and chemicals handling
• Hands-on experience with maintenance of plant equipment
• Exceptional time management skills and ability to manage multiple projects simultaneously
• Clear written communication and sound judgment
• Ability to prioritize work, organize and handle multiple projects simultaneously, and interface with colleagues, internal and external clients, and staff at all levels
• Must be proficient with computers (e.g. MS Office and video-conferencing) and ability to learn specialty software (e.g. BMS).  Ability to own IT systems a plus

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.

Please visit www.lyratx.com for more information.