Director, Process Development Engineering
Description

Lyra Therapeutics, Inc. is a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches. Lyra's XTreo™ platform is comprised of a biocompatible mesh scaffold, an engineered elastomeric matrix and a versatile polymer-drug complex. The company's current pipeline of therapeutics target tissues deep in the ear, nose and throat passages and are designed to deliver continuous drug therapy for up to six months following a single non-invasive, in-office administration. Lyra's lead product candidate, LYR-210, has initiated a Phase 3 clinical trial for the treatment of chronic rhinosinusitis (CRS) as an alternative to primary sinus surgery. Lyra's second product candidate, LYR-220, is entering Phase 3 clinical development and is designed to be an alternative to revision CRS sinus surgery and post-surgical medical management.  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 Director, Process Development Engineering to work on the design, development and scale-up of the process to manufacture a novel transmucosal therapeutic system.  The successful candidate must have previous experience in the scale-up 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 development and be motivated by the opportunity to learn new technologies. 


Responsibilities

  • Identify and design technology to scale-up process to support commercial volumes
  • 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 to 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 to address manufacturing problems and deficiencies to ensure product quality.
  • Prepare and executes technical protocols to evaluate new processes and process changes.  Summarize results in Technical Reports
  • Prepare manufacturing procedures and work instructions for new equipment and processes
  • Perform process/product risk assessments and prepare 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 Engineering Technicians
Requirements
  • B.S. (M.S./Ph.D. a plus) degree in an Engineering or Scientific field with 10+ or more years’ of industry experience in the development of manufacturing processes for the commercialization of medical devices or combination products
  • Experience taking products to commercial launch
  • Areas of expertise:  manufacturing process development, mfg equipment design and troubleshooting in-process 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.

Please visit www.lyratx.com for more information.