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 a Manufacturing Supervisor to ensure the effective use of material, equipment, and personnel in producing quality production, meeting build schedules, providing direction and assistance to work group in order to meet assigned objectives. Reporting to the Manufacturing Operations Manager, this position works closely with manufacturing operators and technicians to ensure uninterrupted supply of products to customers and trial sites.
- Author/revise SOPs, batch records (paper or electronic), deviations, investigations, and training materials to support continuous improvement of manufacturing processes for a combination pharmaceutical, medical device product
- Collaborate with manufacturing personnel to identify opportunities for operational process improvements employing 5S and other Lean Principles
- Work closely with MSAT, Regulatory, Quality Control, and Quality Assurance groups as needed to ensure compliance with GMP regulations and data integrity
- Facilitate cross functional meetings and discussions to gain alignment and resolve issues
- Train Manufacturing Supervisors and Manufacturing Technicians/Operators on document revisions
- Support MSAT/Engineering on the writing and execution of validation plans
- Review completed batch records as needed to support production supervisors
- Assure operations and practices comply with established procedures and according to cGMP
- Acquire technical expertise on regulatory requirements as it relates to manufacturing
- Establish and foster strong collaborative relationships with internal and external partners and service providers
- Bachelor's Degree in an Engineering, Science, Statistics, Math, IT (Software Dev, Engineer), Data Scientist or related fields
- Minimum of 3 years of experience in pharmaceutical or medical device manufacturing or similar regulated industry with prior exposure to FDA 21 CFR 210/211, FDA 21 CFR 820, or ISO 13485 requirements
- Preferred experience with bioresorbable polymers, device manufacturing, validations, and scale up
- Strong technical writing and computer skills
- Strong project management and communication skills, including experience presenting in front of multidisciplinary stakeholders
- Ability to work effectively in a collaborative team environment
- Proven ability to execute and follow-through to completion
- Be a champion of a highly collaborative, transparent, data driven, and a ‘make it happen’ culture
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.