Lyra Therapeutics (Nasdaq: LYRA) is a clinical-stage company pioneering a new therapeutic approach to treat debilitating ear, nose and throat (ENT) diseases that impact the lives of millions of people. Our goal is to transform the ENT treatment paradigm by providing effective front-line solutions for physicians and new treatment options for their patients. In a Phase 1 study, the company observed a rapid, clinically meaningful and durable improvement in symptom score, with 90% of Chronic Rhinosinusitis (CRS) patients having improved symptoms at 24 weeks. A positive Phase 2 study readout of LYR-210 for the treatment of chronic rhinosinusitis with and without nasal polypsis was recently announced and LYR-220 is expected in the clinic next year. Headquartered in the Boston area, Lyra Therapeutics was founded by George Whitesides and Robert Langer, academic luminaries in the fields of chemistry, materials science and biotechnology.
Our team is growing, and we are currently seeking a Production Lead/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 Senior Director of Internal Manufacturing, this position works closely with the Lyra team to ensure uninterrupted supply of product to customers and trial sites.
Key Areas of Responsibility:
- Direct the work activities of production staff members in the manufacture of drug product
- Facilitate the hourly workforce by setting clear expectations on production output, EHS compliance, and quality workmanship
- Develop production schedules in conjunction with process development and supply chain; monitor performance and report status
- Drive implementation of production related quality documentation including but not limited to Batch Records, Change Controls, Deviations and CAPAs to ensure quality and production goals are met
- Ensure that production staff is appropriately trained to meet daily responsibilities
- Run daily manufacturing meetings to foster communication and continuous improvement
- Implement GMP and Lean Practices; establish routine improvement sessions
- Manage production staff, including performance management, development and training
- Bachelor's degree; technical training preferred
- 5+ years of experience as a Manufacturing Lead/Supervisor or related position in operations (Process Engineering, Supply Chain Management, Facilities Management)
- 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
- Supervisory experience including creating work schedules and setting production goals
- Professional communicator both orally (in person and on the phone) and in writing via email and reports
- Strong computer skills and the ability to read and understand drawings, Quality System Regulations and SOPs
- Use of various assembly tools, including microscopes and calipers; able to learn other roles for supplemental coverage when needed
- Demonstrated knowledge of LEAN manufacturing, and quality practices
- Detail oriented with the skills to keep accurate records to the standard necessary to meet pharmaceutical quality standards
- Ability to prioritize workload and demonstrate sound judgment in normal work and emergency situations; thrives in a dynamic, fast paced environment
- Able to work with scientists and engineers; can understand technical topics, problem solve and research errors
- Creative and self-motivated with a strong code of personal ethics
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. For consideration, please submit cover letter and CV.