Senior Clinical Supplies Manager

☞ Catalent Pharma Solutions

View: 104

Update day: 01-06-2024

Location: Bathgate Scotland

Category: Executive management Production / Operation

Industry: Biotechnology Research Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

Remote working

Due to business growth, we have an exciting new opportunity for a Senior Clinical Supplies Manager to join our team. With nearly 25 years of experience, our Bathgate location in Scotland, UK is an integral part of Catalent’s European clinical supply services network. This 141,000 sq. ft. facility has a comprehensive range of capabilities to support sponsors’ studies throughout the UK, Europe and beyond, including clinical supply management, FastChain® demand-led supply, clinical-scale commercial packaging, and QP release services.

This position will report to the CSM Regional Manager and will be a remote based role. As a Senior Clinical Supplies Manager, you will have to perform the activities required to provide leadership and support in the planning, development, and execution of clinical supply chain activities and have the ability to drive cross-functional deliverables and manage activities of supply partners and functions (e.g. packaging and distribution, depots, logistics).

The Senior Clinical Supplies Manager is instrumental in timely planning, accurate forecasting and managing investigational supplies for all phases of clinical trials. The position requires flexibility, teamwork, attention to detail and rapid response to issues as they arise

The Role

  • Understand and translate clinical study protocol requirements into demand for drug product within a clinical study
  • Use simulation tools and supply chain expertise to provide decisions in support of the design of optimized, lean supply chains for individual studies or programs
  • Create initial study drug projections and supply plans for clinical supply needs throughout life of study including multiple drug campaigns and appropriate drug strategies
  • Assist in re-forecasting clinical supplies as a result of strategy changes occurring during the study (enrolment per country, number of sites per country, addition of new countries, etc.) to determine and anticipate the impact on supply forecasts and supply plans
  • Assist in creating a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug
  • Provide input to IRT specification design. Recommend IRT threshold levels and optimize as required to make efficient use of clinical supplies while avoiding stock outs at study sites
  • Works with IRT in creation of system specifications (URS) associated with supply algorithms
  • Act as Unblinded Study Drug Manager in testing of IRT system (UAT) and throughout life of the study
  • Monitor and oversee Warehouse and Depot drug levels within IRT throughout study.
  • Establish reports within IRT (blinded / unblinded) that will be required to monitor/track drug usage and drug forecasting throughout project life
  • Manage drug supply quantities for distribution to designated Warehouses and Depots throughout study

The Candidate

  • Bachelor’s degree in a science, supply chain or related discipline
  • Relevant industry experience with experience in clinical supply management and sound knowledge of the complete clinical supplies life cycle
  • Experience in supply tracking requirements and systems
  • 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), EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP).

Position Benefits

  • Annual Salary
  • Remote based role
  • 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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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.
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Deadline: 16-07-2024

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