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.
Our team is growing, and we are currently seeking a Manufacturing Operations Manager 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 VP, Manufacturing, this position works closely with the Lyra team to ensure uninterrupted supply of products to customers and trial sites.
- Oversee and manage manufacturing activities
- Review, train, and develop Manufacturing Supervisors and Manufacturing Technicians; lead and coach team to drive high performance culture that accommodates rapid and dynamic growthPrepare documentation associated with the job duties
- Assure operations and practices comply with established procedures and according to cGMP
- Acquire technical expertise on the function and control of equipment and techniques related to job function, and regulatory requirements
- Support evaluation, specification, installation, and validation of new manufacturing equipment
- Establish and foster strong collaborative relationships with internal and external partners and service providers
- Establish and maintain detailed manufacturing schedules; define risks and recommend contingency plans as required
- Set goals for the supply chain to include capabilities to support both clinical and commercial supply
- 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 and begin commercial production
- Work collaboratively with the science, engineering, and clinical teams as well as business development to meet the current and future needs of the programs
- BS Degree in Engineering, Chemistry or Biotechnology is required preferred or extensive technical knowledge relating to Lyra’s products
- 3 - 5 years’ experience in technology transfer, supervisory leadership of pharmaceutical manufacturing
- Experience leading and direction tactical decision making adjusting to issues and schedule changes
- 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
- Knowledgeable in polymer chemistry, medical devices, and sterile products
- Experience with bioresorbable polymers, device manufacturing, validations and scale up
- Strong project management, leadership, and communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders
- Strong computer skills and the ability to read and understand drawings, Quality System Regulations and SOPs
- Proven ability to mentor and coach more junior team members and develop a strong scientific team
- 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, ‘make it happen’ culture
- 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.