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 Manufacturing Technicians to support production of drug products. The ideal candidate will be adaptable and motivated by the opportunity to learn new technologies and have proven success in a dynamic and fast-paced environment.

Responsibilities

• Manufacture drug products in cleanroom environment
• Follow all relevant SOPs, batch records, and work instructions
• Adhere to Good Documentation Practices, Good Manufacturing Practices, and Lyra standards when executing all assignments including, but not limited to batch records, lab notebooks, and logbooks
• Work alongside the engineering and QA/QC departments to troubleshoot and solve various production related issues
• Mentor and train employees with less experience on Good Manufacturing Practices and manufacturing steps
• Perform solution preparation for chemical processes, fixture setup, spray-coating, packaging, heating/drying, and microscope visual inspection activities
• Setup and operate equipment, monitor performance, and report any abnormal equipment or product conditions.
• Maintain work area and equipment in a clean, safe, and orderly condition
• Perform routine testing of product/WIP to produce reliable and precise data to support product development while following strict methodology
• Assist in performing required process capability studies, equipment installation/operational qualifications, process validation, and analysis of test data

• Associate’s degree or Bachelor’s degree in Science or Engineering
• 5 to 10 years of related industrial experience in medical device or biotech manufacturing
• Experience with polymeric spray coatings and working knowledge of spray coating technology is a plus
• Proficient with basic lab skills and lab equipment with the ability to safely work with chemicals and solvents
• Work under the direction of supervisors and management. Provide on the floor supervision when needed. Ability to take direction, work independently and with a team, lead on the floor problem solving, manage time, and effectively interact with various groups and personnel
• Ability to adhere to GDP/GMP practices
• Be flexible and work within a small team without strictly defined roles in order to assure complete functional coverage.
• Solid skills in Microsoft Office (Word and Excel)
• Demonstrated commitment to safety
• Available to work 40 hours per week; weekly schedule may change per project demands

At Lyra, we value creativity, leadership, and collaboration. The company sees significant expansion opportunities for our platform and are looking for people who are driven to succeed, innovative, and adaptable. We offer competitive compensation and benefit package with opportunities to join a fast-paced, high performing team. For consideration, please submit a cover letter and CV.