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 Quality Control (QC) Analyst I/II. Reporting to the Director of QC Operations, the QC Analyst I/II will be responsible for sampling/testing/trending of Environmental Monitoring, sampling/inspection/testing of raw materials, management of stability as well as overall trending of test data and aligning with external CMO/CTOs. The individual will also 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. The position will interact with Supply Chain, Quality Assurance, Manufacturing, Development, and external CMO/CTLs.
- Perform routine Environmental Monitoring and utilities testing in accordance with SOPs and cGMP guidelinesPerform in-process testing such as Bioburden, Endotoxin and mechanical limits, as well as routine QC sampling, inspection and testing of raw materials
- Perform microbial limits and identifying and trending microorganisms
- Participate/lead clinical and phase appropriate method tech transfer for raw materials
- Perform QC sample receipt for internal testing, outside laboratory testing, login, processing, shipment, tracking, distribution of test results, and closure
- Assist in the review of QC data and provide summaries to management as needed
- Report out-of-specification or out-of-trend results in a timely manner to ensure appropriate actions are taken
- Performance of QC general laboratory equipment calibration and maintenance, laboratory housekeeping and preparation of the laboratory for audits; act as back up for QC instrument maintenance and calibrationAuthor and conduct periodic review to QC documents, including SOPs, protocols and forms
- 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
- Ensure that all Quality Control activities are conducted in accordance with current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements
- Assist QC Management, as needed, in the completion of OOS, deviations, change controls and CAPAs
- Utilize a range of electronic systems such as LIMS and document/equipment management software
- Collaborate with internal departments and teams to support QC testing, change controls, and CAPAs
- Actively promote safety rules and awareness. Reports and takes initiative to correct safety & environmental hazards. Always demonstrate good safety practices including the appropriate use of protective equipment
- Train on and maintain knowledge of current regulatory requirements and relevant internal procedures
- Work on special projects as needed and contribute towards continuous improvement activities as assigned
- BA/BS or MS degree in Chemistry, Biochemistry, Microbiology, Biology or other related field with 1-4 years of GMP experience within Quality Control
- Demonstrate knowledge of USP, EP, JP monographs
- Demonstrate knowledge of cGMP/ICH/FDA/EU regulations
- Excellent written and verbal communication skills
- Ability to work under supervision and/or function independently, exercise good judgement and work in a fast-paced team-based environment
- Collaborative team player who fosters open communication and builds relationships with stakeholders
- Strong analytical, organization, and communication skills with a positive attitude
- Strong knowledge of cGMPs and Quality Systems
- Knowledge of Laboratory Information Management Systems (LIMS)
- Some non-routine travel may be required
- Flexibility with scheduling requirements-may include shifts, overtime, weekends, and holiday coverage, including during adverse weather conditions
- Must be able to lift 50 lbs.
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.