Director/Associate Director, CMC
Job Type
Full-time
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 currently hiring a Director/Associate Director, 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. 


Responsibilities

  • 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
  • Perform risk assessments of manufacturing process scale-up and use Quality by Design (QbD) principles to define the design space and develop overall control strategy
  • Formulate drug substance development strategy to ensure product quality, facilitate regulatory approvals and achieve operational flexibility of supply chain
  • 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
  • Manage all aspects of supply chain activities including vendor selection and evaluation, and clinical trial material supply
  • Proven ability to mentor and coach more junior team members and develop a strong scientific team
  • Be a champion of a highly collaborative, transparent, data driven, ‘make it happen’ culture
  • 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
Requirements
  • BS Degree in Engineering, Chemistry or Biotechnology is required; an advanced degree (MS, PhD, PharmD) is preferred
  • Minimum of 10 years’ experience in drug product development as well as technology transfer and pharmaceutical contract manufacturing
  • Experience in drug substance development, formulation development, process development, clinical and commercial cGMP production including process validation experiments, preapproval inspections, and commercial manufacturing
  • Knowledgeable in combination products, polymer chemistry, medical devices, and sterile products
  • Strong analytical skills and problem-solving skills with a track record of identifying and implementing novel solutions
  • Proven leadership and communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders

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.