Senior Clinical Supplies Manager page is loaded
Senior Clinical Supplies Manager
Apply locations Bathgate, United Kingdom time type Full time posted on Posted 2 Days Ago time left to apply End Date: February 28, 2025 (3 days left to apply) job requisition id R919518
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
We are looking to recruit a Senior Clinical Supplies Manager (CSM) to join our team supporting our Clinical Supplies network globally.
The Senior Clinical Supplies Manager (CSM) should demonstrate expertise in performing the activities required to provide leadership and support in the planning, development, and execution of clinical trial supply chain activities and have the ability to drive cross-functional deliverables and manage activities of multiple supply partners and functions (e.g., packaging and distribution, depots, logistics). This role is instrumental in timely planning, accurate forecasting and in managing investigational supplies for all phases of clinical trials. The position requires flexibility, teamwork, attention to detail, and the ability to respond rapidly to issues as they arise.
The Role
* Understand and translate clinical study protocol requirements into demand for drug product and ancillary supplies within a clinical study.
* Use simulation tools and supply chain expertise to provide decision support for the design of optimized, lean supply chains for individual studies or programs.
* Create study drug projections and supply plans for clinical trial supply needs throughout the life of the study including multiple drug campaigns and appropriate drug strategies.
* Work with IRT in the creation of system specifications (URS) associated with supply algorithms.
* Update clinical supply demand forecasts as new information becomes available (Excel and available forecasting tools).
* Act as the Un-blinded Study Drug Manager in testing of IRT system (UAT) and throughout the life of the study.
* Monitor and oversee Warehouse and Depot drug levels within IRT throughout the study.
* Coordinate with the client and packager to forecast, plan and schedule packaging campaigns and drive timeline to the desired deliverable.
* Manage drug supply quantities for distribution to designated Warehouses and Depots throughout the study.
* Establish reports within IRT (blinded/unblinded) that will be required to monitor/track drug usage and drug forecasting throughout project life.
The Candidate
* Bachelor's degree in a science, supply chain or related discipline.
* Extensive, proven relevant industry experience in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle.
* Experience in supply tracking requirements and systems.
* Experience in the use of forecasting tools.
* Global logistics experience/understanding related to supply chains, import/export and drug depots, comparator or co-therapy product sourcing and project management.
* Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR).
* Strong knowledge in IRT technology as it relates to supply chain management.
* Experience of using MS Office programs, with a particular aptitude for MS Project and Excel.
Position Benefits
* Annual Salary
* Pension
* Bonus
* Life Assurance
* Bupa Healthcare
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
About Us
Catalent = Catalyst + Talent
Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!
personal initiative. dynamic pace. meaningful work.
Catalent is the perfect place to grow your career if…
* You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
* You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!
* You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
* You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
* You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!
* See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.
#J-18808-Ljbffr