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 a Vice President of Analytical Development and Quality Control (AD/QC). Reporting to the Chief Technology Officer, the VP of AD/QC will define and shape strategies for the internal and external AD/QC network, ensuring a high level of cGMP compliance as well as the quality, safety, and efficacy of Lyra’s clinical and anticipated commercial stage products.  The applicant will lead the development and implementation of robust analytical methods, QC testing and control strategies, stability programs, and associated regulatory compliance activities.  The applicant will oversee development of appropriate in- vs. out-sourcing strategies as the lead program, LYR-210, advances through Phase 3 clinical development towards licensure and commercialization.  

Responsibilities

• Provide strategic direction and vision for the AD/QC department, aligning it with the overall company objectives and regulatory requirements
• Collaborate with other functions (e.g. R&D, Manufacturing, Quality Assurance, and Regulatory Affairs) to develop and implement appropriate control strategies for all stages of product development and manufacturing
• Collaborate with other departments to implement quality and process improvement initiatives
• Oversee the development, validation, and implementation of appropriate analytical methods for the analysis of raw materials, intermediates, and finished products
• Ensure that all Quality Control activities are conducted in accordance with current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements
• Author and review IND/NDA Module 3 sections, with primary responsibility for Characterization/Impurities, Analytical Methods/Validation, Batch Analysis, Specifications, and Stability
• Stay abreast of evolving regulatory requirements related to analytical development and Quality Control in the pharmaceutical industry
• Manage and develop a team of skilled professionals, providing mentorship and fostering a culture of excellence and innovation
• Maintain productive relationships with outsourced testing partners, actively managing all contracted activities
• Allocate internal and external resources efficiently to meet project timelines and departmental objectives
• Develop and monitor Key Performance Indicators (KPIs) for the AD/QC department
• Prepare and present regular reports to management on quality-related metrics and compliance status

• An advanced degree (MS or PhD) in Chemistry or a related discipline is preferred
• Extensive experience (15+ years) in the pharmaceutical industry, with a strong background in the AD and QC functions, phase-appropriate requirements, and at least 10 years of experience in a managerial role
• Proven track record of successful collaboration with key stakeholder functions (e.g. R&D, Manufacturing, Quality Assurance, and Regulatory Affairs)
• Experience with the buildout of internal testing laboratories as well as the management of external testing laboratories.  
• In-depth knowledge of current regulatory requirements and guidelines for pharmaceutical Analytical Development and Quality Control (cGMP, ICH, FDA, EMA, etc.)
• Direct experience as a lead author of relevant Module 3 sections and supporting regulatory authority inspections.
• Experience with computerized systems (e.g. LIMS) and their associated compliance requirements
• Strong problem-solving and decision-making skills with the ability to navigate complex challenges in a regulated environment.
• Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization
• The position is based in the Boston area, supporting Lyra’s development site in Watertown, MA and commercial manufacturing site in Waltham, MA.  The ability to travel approximately 10 % of the time is required

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.