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. For more information, please visit www.lyratherapeutics.com and follow us on LinkedIn and Twitter.
Lyra Therapeutics is seeking a talented, independent, and highly motivated Clinical Supply Chain Senior Manager with expertise in supply chain management to join our Operations Team. This role will be responsible for day-to-day activities related to managing the supply of Clinical Trial Material (CTM) through all stages of clinical development including packaging, labeling and distribution. This role will support and advise Clinical Operations, Regulatory, Quality and clinical sites on all aspects of CTM and comparator products as applicable. This position will report to the Senior Director of Manufacturing.
- Support clinical supply activities for on-going and new clinical trials including demand forecasting, trial monitoring, resupply planning, IRT set-up, distribution activities
- Candidate will be very hands on with day-to-day operations and be also involved in strategic decisions in clinical supply chain
- Design and execute packaging and labeling campaigns including but not limited to; timeline management, documentation approval, and coordination with contract packaging, labeling and distribution providers
- Review clinical protocols and design appropriate supply chain strategy for new studies.
- Ensure on time startup of new studies by having supplies available as required
- Ensure continuous supply of clinical trial material for ongoing studies within the US and ex-US locations
- Provide appropriate information to stakeholders on the status of clinical supplies
- Effectively coordinate activities with the broad Technical Operations team to align Drug Product and SHAM bulk manufacturing plans and execution with clinical supply plans
- Drive timelines of requested bulk manufacturing, packaging, labeling and final release to meet forecasted demand
- Drive resolution of logistics issues, including but not limited to supply chain services, inventory control, import-export, shipment of products and third-party warehousing
- Manage activities, such as expiry extensions, returns and temperature excursions
- Manage Lyra’s relationship with contract packaging, labeling, and distribution providers
- Establish and maintain process with Accounts Payable and Legal to effectively manage on-time approvals of purchase orders, change orders and invoices of Contract Development and Manufacturing Organizations (CDMO)
- Work collaboratively and transparently with partners, Clinical Operations, Pharmaceutical Sciences, Quality Assurance and Regulatory Affairs
- BS degree with 5-7 years’ experience in a Supply Chain Planning role in a Biotechnology or Pharmaceutical environment including at least 1 year that is Clinical Supply specific
- Excellent project management, organizational and communication skills
- Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials
- Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient
- Experience managing contract packaging and labeling organizations (strongly preferred)
- Project Management Professional certification is a plus
- Thorough understanding of regulatory requirements for clinical supply distribution in US, and EU including testing and labeling requirements is a plus
- Experience working with QP, IRTs, depots with global CTM distribution
- Periodic travel to Lyra and partner sites (approximately 20% of time), including some international sites, in accordance with applicable COVID-related travel guidelines
- Strong computer skills (Word, Excel, Outlook, PowerPoint, Smartsheet/MS Project), with demonstrated expertise in creating and using spreadsheets for material planning
- Attention to detail with excellent problem-solving ability
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.