Director, CMC Project Management
Description

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.


This new director-level position within the CMC department will coordinate multi-disciplinary projects in product development, process development, materials, supply chain, analytical, validation, and manufacturing of our LYR-210 and LYR-220 drug/device combination products. Reporting to the Vice President of CMC, the Project Manager will have high visibility and impact across the organization and is key to guiding startup and validation of a new commercial manufacturing facility in Waltham MA, development of market applications, and coordination of technical operations for successful product launch.


Responsibilities

  • Project Planning and Execution: Develop comprehensive project plans, including timelines, deliverables, resources, and milestones. Actively monitor progress to ensure adherence to plans and communicate potential delays and issues. Ensure project data and decisions are tracked and reported appropriately
  • Project Leadership: Contribute to strategic planning, preparation of budgets, and provide guidance to project teams. Foster cross-functional collaboration and data-driven decision-making. Organize and run efficient productive meetings as needed, including agendas, materials, and minutes
  • Cross-Functional Collaboration: Work closely with across functional teams, including product development, regulatory affairs, manufacturing, quality assurance, quality control, facilities, MSAT, and validation to align project objectives and ensure seamless coordination between departments
  • Resource Management: Coordinate efficient resource utilization, and proactively identify and communicate resource constraints
  • Risk Management: Proactively anticipate project risks, propose solutions, develop contingency plans, and implement mitigations
  • Stakeholder Communication: Regularly communicate project status, updates, and milestones to stakeholders, including senior management, team members, and key external partners. Support development of executive presentations that communicate plans, progress, decisions, and risks
Requirements
  • Bachelor's degree in a scientific discipline, pharmaceuticals, or a related field
  • Proven experience as a Project Manager 5+ years and at least 10 years in the pharmaceutical or medical device industries
  • A track record of successfully managing complex projects from initiation to completion is essential
  • Strong project management skills, including project planning, risk management, and resource allocation
  • In-depth knowledge of pharmaceutical CMC development, including regulatory and manufacturing aspects. Experience with startup of a commercial GMP manufacturing facility is a strong plus
  • Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders at all levels of the organization
  • Demonstrated leadership capabilities, with the ability to motivate and inspire cross-functional teams
  • Proficiency in project management methodologies, tools and software, including Smartsheet and MS Project
  • Experience in defining and tracking budgets is a plus
  • PMP certification (Project Management Professional) is a plus

At Lyra, we value creativity, leadership, and collaboration. The company sees significant expansion opportunities for our platform, and looks for people who are driven to persevere, adapt, innovate to help us succeed.  For consideration, please submit a cover letter and CV.