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 the Quality Control & Analytical Development team is recruiting for a highly organized and experienced QC and Analytical Scientist. The principal responsibilities of this role are to oversee or perform analytical testing in support of GMP drug product manufacturing (release and stability), review and approve test results, develop procedures and infrastructure to establish in-house GMP testing capabilities and coordinate logistics for the testing of critical samples.  This individual will also develop, validate and troubleshoot analytical methods, as well as  perform testing to support process development and R&D activities.

The person in this role will have extensive interactions with internal stakeholders and external contract labs, and must maintain good working relationships in order to be successful.  Previous experience working in a GMP, Quality Control, or highly regulated environment is strongly preferred. The QC/Analytical Scientist will work on-site in our Watertown headquarters (moving to Waltham in 2024).

Responsibilities

• Perform or oversee Quality Control compliant testing of GMP drug product and raw materials in-house or at external contract labs
• Develop procedures and infrastructure to establish and enhance in-house GMP testing capabilities
• Analyze and interpret data generated and record data in a GMP compliant manner
• Write study protocols, test methods and technical reports, and take part in laboratory investigations, as needed
• Operate, maintain, calibrate and troubleshoot laboratory equipment and analytical methods. Participate in budget planning for capital equipment.
• Review/approve analytical data or author protocols and reports as required 
• Continuously strive to improve processes and procedures, while ensuring strict compliance to Quality requirements and regulations

• BS or MS Degree in chemistry or related scientific discipline 
• 5+ years of experience across more than one of the following areas: Analytical/QC testing, establishing/maintaining GMP testing environment, analytical method validation and transfer, raw material qualification;  level of position may be commensurate with experience
• Proficient with analytical instrumentation such as HPLC, UV, GC, GPC & FTIR with the aptitude to be trained on additional analytical equipment; experience in validating analytical methods
• Strong general laboratory and organizational skills, attention to detail, effective communication skills, both oral and written
• Experience in GMP pharmaceutical or other regulated industry, as well as knowledge of regulatory requirements (e.g., US, EU, USP) and prior experience supporting regulatory agency inspections strongly preferred
• Competency with common software programs (Word, Excel, Outlook, PowerPoint), with demonstrated expertise in creating and using spreadsheets
• Must work independently with a demonstrated ability to prioritize, manage and coordinate multiple parallel activities and thrive in a dynamic, fast paced environment

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 CV.