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.

Lyra Therapeutics is recruiting an Associate Director/Director of Quality Control (QC). Reporting to the Associate VP of QC, the Associate Director/Director of QC will be responsible for oversight of raw material testing, sampling and inspection as well as developing a raw materials strategy, determining raw material requirements and incoming testing approaches, and aligning with external CMO/CTOs. The individual will be responsible for maintaining and tracking testing samples, backups, retains as well as overseeing the inventory of laboratory chemicals and critical reagent supplies across both the Watertown and Waltham facilities. This position will also be responsible for overseeing the Environmental Monitoring (EM) program (sampling, testing, trending), management of stability as well as overall trending of test data. The position will interact with Supply Chain, Quality Assurance, Manufacturing, Development, and external CMO/CTLs.  

Responsibilities

• Oversee raw material testing, sampling and inspection
• Develop/Implement Raw Material strategy and policies
• Develop/Implement sample receipt and retain management procedures
• Implement and manage critical reagent/control procedures
• Oversee the Environmental Monitoring program (including sampling, testing and trending)
• Manage the stability program (including study implementation, pull schedule and trending)
• Determine incoming testing requirements for compendial and non-compendial materials
• Assist in managing supplier issues and participate in vendor audits
• Collaborate with 3rd party/ external contract testing labs to onboard materials, methods, and on external quality investigations as applicable
• Participate/lead clinical and phase appropriate method tech transfer for raw materials
• Provide technical and operational expertise for training and developing staff, assisting in troubleshooting, and performing investigations for out of specification results
• Recruit and develop a high performing team with diverse backgrounds and talents. Coach direct reports to evaluate and execute continuous improvement, develop their skill sets, and creates an environment of continuous learning, improvement, and innovation
• Conduct investigations when necessary with cross-functional groups
• Ensure that all Quality Control activities are conducted in accordance with current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements
• Author revisions to SOPs for managerial review and approval and drafts new documentation where appropriate
• Maintain and communicate team performance metrics, setting high expectations for team performance
• Drive staff schedules to meet workflow demands and monitors expenditures to prevent budget overruns 
• Author and review IND/NDA Module 3 sections
• Maintain productive relationships with outsourced testing partners, actively managing all contracted activities

• BS or MS degree in Chemistry, Biochemistry, Microbiology, Biology or other related field with 10+ years of GMP experience within Raw Materials and Quality Control
• Demonstrate knowledge of USP, EP, JP monographs 
• Demonstrate knowledge of cGMP/ICH/FDA/EU regulations
• Proven ability to demonstrate a strong initiative and scientific leadership
• Collaborative team player who fosters open communication and builds relationships with stakeholders 
• Self-directed individual who can work with limited direction in a fast-paced environment
• A professional communicator with strong analytical and organizational skills and a positive attitude
• Excellent project management and organizational skills with the ability to work on multiple projects with varying complexity and timelines
• Strong knowledge of statistical software and principles
• Strong knowledge of cGMPs and Quality Systems and a background in data integrity
• Knowledge of Laboratory Information Management Systems (LIMS)
• Limited travel (10%) 
• Flexibility with scheduling requirements-may include shifts, overtime, weekends, and holiday coverage, including during adverse weather conditions

At Lyra, we value creativity, leadership, and collaboration.  The company sees significant expansion opportunities for our platform, and looks 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.