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 Quality team is growing and we are currently seeking a Manager/Senior Manager of GMP QA Operations to play a pivotal role in ensuring the quality and compliance of our manufacturing processes as we progress toward commercialization. Reporting to the Sr. Director, QA Operations, the Manager will oversee a team responsible for overseeing manufacturing, batch record release, investigations, deviations, CAPAs, and change controls within our GMP operations.

Responsibilities

Manufacturing Oversight:

• Lead and oversee GMP manufacturing activities, ensuring compliance with regulatory requirements and internal quality standards
• Collaborate with cross-functional teams to streamline manufacturing processes and maintain product quality
• Provide leadership and guidance to the manufacturing team to ensure compliance with GMP (Good Manufacturing Practices) regulations
• Provide GMP guidance to third-party vendors to ensure product meets Lyra Therapeutics quality expectations and compliance of products with cGMP
• With limited guidance, support and/or lead continual improvement initiatives in order to realize operating efficiencies in support of product release
• With limited guidance, help and support the QP audit process for approval of assigned product and batches outside USA

Batch Record Release:

• Manage the batch record review and release process to ensure timely and compliant release of clinical batches
• Review batch records for accuracy and completeness and address any discrepancies or deviations

Investigations, Deviations & Change Control:

• Lead investigations into manufacturing discrepancies, deviations, and non-conformities, ensuring thorough root cause analysis and effective corrective and preventive actions (CAPAs)
• Develop and implement corrective and preventive actions (CAPAs) to prevent recurrence of issues
• Assess the impact of changes on product quality and regulatory requirements

Quality Assurance Leadership:

• Provide guidance, mentorship, and leadership to the QA Operations team
• Foster a culture of continuous improvement and commitment to quality
• Collaborate cross-functionally with R&D, Manufacturing, Regulatory Affairs, and other departments to facilitate effective communication and resolution of quality-related issues

Continuous Improvement:

• Identify opportunities for process improvements and efficiencies within the QA Operations function, driving continuous improvement initiatives

• Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred
• Minimum of 8 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry
• Strong understanding of GMP regulations and quality standards.  Experience with Combination products a plus
• Previous experience in a leadership or managerial role
• Excellent communication, problem-solving, and decision-making skills
• Ability to work effectively in a fast-paced, dynamic environment
• Detail-oriented with a commitment to quality and compliance

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.