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.
We are currently hiring a Manager, CMC, responsible for the management of Lyra’s CMC related activities. This hands-on position is a key leadership role that requires technical leadership to support CMC aspects of technology development, documentation transfer and manufacturing.
- Lead the CMC aspects of technology transfer and external manufacturing and product/process development activities for drug/device combination products from clinical development through commercialization
- Manage all aspects of supply chain activities including vendor selection and evaluation, and clinical trial material supply
- Prepare specifications for drug substances and drug products for clinical use and interface with clinical centers to ensure that compounds are stored, administered, and destroyed in accordance and compliance with appropriate regulatory procedures
- Establish and foster strong collaborative relationships with internal and external partners and service providers
- Establish and maintain detailed project plans; define risks and recommend contingency plans as required
- Set a vision and strategy for the CMC organization to include compliant and robust “Quality by Design” capabilities
- Work closely with technical consultants and eventually develop a strong multifunctional team(s) to deliver high quality supply performance to meet key targets of clinical development plan
- Work collaboratively with the science, engineering and clinical teams as well as business development to meet the current and future needs of the programs
- Lead and coach team to drive high performance culture that accommodates rapid and dynamic growth
- Write and/or review CMC sections of regulatory documents and submissions