Liquidia Corporation · 1 month ago
Manager, Clinical Supply Chain
Morrisville, NC
Full-time
Hybrid
Senior Level
7+ years expLiquidia Corporation is dedicated to the discovery and development of novel therapies for patients and healthcare providers. The Manager, Clinical Supply Chain is responsible for managing drug supply activities, overseeing supply plans, and ensuring the continuous supply of clinical trial materials while minimizing waste and risk. This role involves collaboration with internal stakeholders and external partners to enhance the clinical supply chain processes.
BiopharmaBiotechnologyHealth CareNanotechnologyTherapeutics
Hiring Manager
Brian Duggan
Responsibilities
Represent the Clinical Supply Chain on Clinical Study Teams (CST) and provide a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC)
Working with Clinical Operations, interpret clinical study protocols to understand clinical supply needs and demand requirements and ensure alignment with study teams to supply plans and timelines
Create supply and inventory plans and develop production schedules for clinical trial materials
Monitor schedule adherence of production schedules and make course corrections if needed
Manage GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability
Manage the relationship and oversee daily activities for FG label & pack CMOs and distribution vendors
Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure
Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s)
Coordinate review and approval of labels with stakeholders (e.g. Regulatory, Clinical Operations, CRO) and CMOs
Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system. Serve as unblinded drug supply manager when required
Coordinate and track bulk shipments to CMOs, depots, and vendors. Maintain and track import licenses
Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
Lead cross functional projects and process improvements related to drug supply
Assist in the creation of Standard Operating Procedures
Manage change controls for Clinical Supply Chain
Work with Regulatory to provide to support IND or other regulatory submissions
All other duties as assigned
Qualification
Required
BS degree in life science or technical discipline
At least 7+ years progressive experience in Supply Chain preferably within the biotech, pharmaceutical, CRO, industry
Experience with supporting a multi-country, double-blinded study is required
Experience working with QP and working knowledge of global regulations for investigational medicinal products, such as Annex 13 and the EU CTR & CTD
Experience with understanding and development of user requirements, acceptance testing, and utilization of IRT/RTSM, depots and global IP distribution
Experience managing the logistics of domestic and international shipments in support of clinical production
Demonstrates ability to champion, inspire, collaboratively create, and execute sound business processes
Strong management and organizational skills and detail orientation with an ability to prioritize, enable, and accelerate multiple programs and projects while simultaneously delivering against the activities of daily operations
Ability to thrive in a multidisciplinary team environment is essential for success, with a strong ability to build relationships
Proven agility and success in a dynamic company / business environment where change is frequent and rapid understanding and alignment is paramount
Computer skills including Microsoft Office Suite products and working knowledge of various operational software systems including IRT software
Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials
Excellent project management and communication skills, with particular emphasis on negotiating and problem solving
Preferred
A degree in Supply Chain Management or certification preferred
Benefits
Medical
Dental
Vision
STD
LTD
401(k) Savings Retirement Plan
ESPP
Unlimited Paid Time Off
Company
Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company focused on the development and commercialization of products in pulmonary hypertension and other applications of its PRINT® Technology.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$533.4MKey Investors
HealthCare Royalty PartnersPatient Square CapitalSilicon Valley Bank
2025-06-23Post Ipo Debt· $50M
2024-09-11Post Ipo Equity· $67.5M
2024-01-04Post Ipo Equity· $75M
Leadership Team
Roger Jeffs
Chief Executive Officer
Mike Kaseta
Chief Financial Officer
Recent News
2026-01-07
New Enterprise Associates
2026-01-06
Company data provided by crunchbase