Clinical Supply Chain Pharmacy Specialist
|Job Title:||Clinical Supply Chain Pharmacy Specialist|
|Salary:||£TBD on application plus benefits including bonus|
|Contact Name:||Alex Butcher|
|Job Published:||September 25, 2020 09:31|
You will join a leading Biopharmaceutical company who develop and manufacture a wide range of life-changing vaccine treatments and diagnostic kits. They have developed an innovative approach to immunotherapy over several decades and are in an exciting phase of expansion across Europe and the USA. This is a genuinely exciting, varied opportunity for an ambitious, confident individual with strong communication skills and positive energy.
Working in close partnership with various departments (including Clinical Development, Clinical Science, Clinical Operations, Project Management, CMC, Regulatory Affairs, QA and QC), you will be the primary point of contact for all matters related to the supply of clinical trial material. Products are manufactured on the Worthing site under strict sterile conditions, and you will be responsible for overseeing the supply of investigational products, companion diagnostics and ancillary supplies to meet the requirements of the patients, investigators and business objectives.
As Clinical Supply Chain Manager, your role will include:
• Translating clinical trial protocols and study plans into a comprehensive clinical supply strategy
• Forecasting the amount of clinical trial material required
• Developing a pharmacy manual to support investigational teams at study sites to prepare accurate doses of the investigational product
• Collaborating with the Principal Data Manager and Biostatistician in building a new randomisation and trial supply system (RTSM)
• Leading the clinical trial supply vendor selection process
• Liaising with the Early Phase Project Manager to ensure supply chain logistics are consistent with requirements for transfer of materials, e.g. requirements for cold chain, product shelf-life and interpretation of study protocols
• Liaising with Head of QA to identify and resolve any quality related issues in clinical supply chain
• Providing strategic input for future projects in terms of improvement in Clinical Supply Chain management
• Systems and Change Management, integrating processes with all operational departments
Full details will be provided on application.
Skills and Experience
The successful candidate will ideally have a background as a Pharmacist or Pharmacy Technician, with experience that has included clinical supply chain management and supply chain logistics. You will need to have worked in a clinical trial-related setting, whether in a CTS organisation, a Pharma company or another environment related to clinical supply, forecasting and stock inventory management. You will need to demonstrate an understanding of ICH, EMEA, MHRA and FDA guidelines, and quality management systems in a clinical setting. We are looking for an astute, versatile individual who has formed and developed collaborative partnerships with 3rd party vendors and has experience of vendor selection and management. You must be able to demonstrate the ability to learn, listen actively to others, and build mutually beneficial relationships.
Get similar jobs like these by email
By submitting your details you agree to our T&C's
Highly competitive salary & benefits
Clinical Project Manager - Innovative Biotech
£50000 - £65000 per annum, Benefits: bonus, share option scheme, pension, life insurance, 25 days holiday
c£55K plus bonus, shares and benefits
Project Manager - Cell & Gene Therapies
£0 - £60000 per annum, Benefits: bonus, pension, life insurance, health insurance 28 days holiday
Director of Viral Vector Manufacturing