Senior/Principal Process Development Engineer
Watertown, MA Process Development
Job Type
Full-time
Description

  

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 looking for a hands-on and energetic Senior Process Development Engineer to work on the design and development of the process to manufacture a novel transmucosal therapeutic system. The successful candidate must have previous experience in the development of processes to support the commercialization of medical device products,  thrive in a fast-paced start-up environment, be adaptable to work on several aspects of product and process development and be motivated by the opportunity to learn new technologies. 


Key Areas of Responsibility:

  • Develop manufacturing processes to support clinical studies and the commercialization of Lyra’s products
  • Use Design of Experiments (DOE) and statistical analysis to establish robust process specifications for the validation of manufacturing processes
  • Drive continuous improvement initiatives, including lean manufacturing, risk assessments, and cost/benefit analysis
  • Manage external suppliers to evaluate,  select and validate raw materials and equipment
  • Identify new technologies to support the commercialization of new products
  • Evaluate the performance of equipment and processes to optimize their efficiency
  • Lead investigations, deviations, and CAPAs to address manufacturing problems and deficiencies to ensure product quality.
  • Prepare and executes technical protocols to evaluate new processes and process changes.  Summarizes results in Technical Reports
  • Prepare manufacturing procedures and work instructions for new equipment and processes.
  • Perform process/product risk assessments (dFMEA, pFMEA, QbD) and prepares reports according to company procedures
  • Support the preparation of regulatory submissions, scientific/engineering papers, grant applications, invention disclosures, and patents
  • Execute timelines and milestones as part of project planning
  • Collaborate with Quality to ensure compliance to appropriate ISO/FDA regulations for the design and manufacture of human use products
  • May manage junior Engineers 
Requirements

  

  • B.S. (M.S./Ph.D. a plus) degree in an Engineering or Scientific field with 8 or more years’ of industry experience in the development of manufacturing processes for the commercialization of medical devices or combination products
  • Experience taking one or more products to commercial launch
  • Areas of expertise:manufacturing  process development, in-procss and finished goods test method development, statistical analysis
  • Knowledge and experience in biomedical test method development,  process validation, and execution
  • Experience and working knowledge of the U.S. and International standards governing the design, development and manufacture of drug products and medical devices
  • Ability to work on multiple projects simultaneously, prioritize assignments, and adapt in a fast-paced environment
  • Excellent written and verbal communication skills
  • Collaborative team player who enjoys working in a highly dynamic, cross-disciplinary environment
  • Must be able to analyze / synthesize data and communicate issues, findings, processes and ideas in a clear, concise, technically-proficient manner

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.