Liquidia Corporation
Clinical Supply Chain Associate
Liquidia Corporation, Morrisville, North Carolina, United States, 27560
Clinical Supply Chain Associate
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Clinical Supply Chain Associate
role at
Liquidia Corporation .
Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary arterial hypertension (PAH). We will continue to combine our proprietary, innovative PRINT Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.
Job Summary The Clinical Supply Chain Associate will support drug supply activities related to planning, label development, label & pack, and distribution for one or more clinical programs. Actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste. Has a working knowledge of clinical supply best practices, IRT systems, as well as experience working within a cGMP environment.
Job Responsibilities
Assist the Clinical Supply Chain Manager in supporting Clinical Study Teams (CST) and providing service to internal stakeholders (e.g., Clinical Operations, Regulatory, Quality, CMC).
Help interpret clinical study protocols to understand supply needs and assist in aligning supply plans and timelines.
Support the creation and maintenance of supply and inventory plans for clinical trial materials.
Monitor production schedules and inventory under supervision, report discrepancies or issues to the Manager.
Assist in managing GMP inventory, preparing inventory reports, and tracking drug accountability.
Support relationships and daily activities with label & pack CMOs and distribution vendors as directed.
Help investigate exceptions and support implementation of corrective actions under guidance.
Assist in ensuring label text and proofs meet applicable rules, regulations, and study protocols.
Coordinate review and approval of labels with stakeholders and CMOs as assigned.
Support IRT user acceptance testing and ongoing supply activities in the system.
Help coordinate and track shipments to CMOs, depots, and vendors; assist with import license tracking.
Contribute to supply strategies to maximize efficiency and minimize waste, under supervision.
Participate in cross-functional projects and process improvements related to drug supply as assigned.
Assist in the creation of Standard Operating Procedures.
Support change controls for Clinical Supply Chain as directed.
Work with Regulatory to provide documentation for IND or other regulatory submissions as needed.
All other duties as assigned.
Job Requirements Education and Experience
BS degree in life science or technical discipline. A degree in Supply Chain Management or certification is preferred.
At least 3+ years experience in Clinical Supply Chain preferably within the biotech, pharmaceutical, CRO industry.
Familiarity with clinical trials and supply chain processes is required.
Basic understanding of global regulations for investigational medicinal products is a plus.
Experience or coursework related to logistics, inventory management, or pharmaceutical materials is desirable.
Knowledge, Skills, and Abilities
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.
Compensation and Benefits Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!
Equal Opportunity Employment Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
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Clinical Supply Chain Associate
role at
Liquidia Corporation .
Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary arterial hypertension (PAH). We will continue to combine our proprietary, innovative PRINT Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.
Job Summary The Clinical Supply Chain Associate will support drug supply activities related to planning, label development, label & pack, and distribution for one or more clinical programs. Actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste. Has a working knowledge of clinical supply best practices, IRT systems, as well as experience working within a cGMP environment.
Job Responsibilities
Assist the Clinical Supply Chain Manager in supporting Clinical Study Teams (CST) and providing service to internal stakeholders (e.g., Clinical Operations, Regulatory, Quality, CMC).
Help interpret clinical study protocols to understand supply needs and assist in aligning supply plans and timelines.
Support the creation and maintenance of supply and inventory plans for clinical trial materials.
Monitor production schedules and inventory under supervision, report discrepancies or issues to the Manager.
Assist in managing GMP inventory, preparing inventory reports, and tracking drug accountability.
Support relationships and daily activities with label & pack CMOs and distribution vendors as directed.
Help investigate exceptions and support implementation of corrective actions under guidance.
Assist in ensuring label text and proofs meet applicable rules, regulations, and study protocols.
Coordinate review and approval of labels with stakeholders and CMOs as assigned.
Support IRT user acceptance testing and ongoing supply activities in the system.
Help coordinate and track shipments to CMOs, depots, and vendors; assist with import license tracking.
Contribute to supply strategies to maximize efficiency and minimize waste, under supervision.
Participate in cross-functional projects and process improvements related to drug supply as assigned.
Assist in the creation of Standard Operating Procedures.
Support change controls for Clinical Supply Chain as directed.
Work with Regulatory to provide documentation for IND or other regulatory submissions as needed.
All other duties as assigned.
Job Requirements Education and Experience
BS degree in life science or technical discipline. A degree in Supply Chain Management or certification is preferred.
At least 3+ years experience in Clinical Supply Chain preferably within the biotech, pharmaceutical, CRO industry.
Familiarity with clinical trials and supply chain processes is required.
Basic understanding of global regulations for investigational medicinal products is a plus.
Experience or coursework related to logistics, inventory management, or pharmaceutical materials is desirable.
Knowledge, Skills, and Abilities
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.
Compensation and Benefits Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!
Equal Opportunity Employment Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
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