Reference Number: JO-2002-445283
Senior Manager: Clinical Supplies
Rate: £45,000 – 50,000
Job Type: Permanent
Senior Manager: Clinical Supplies Leading UK Biotech
Location: South Cambridge
Salary: 45,000-50,000 + 10% Bonus and outstanding benefits package
If you are inspired by developing your career in a stimulating environment where you can make a profound difference to the healthcare of patients, my client can offer exceptional careers for exceptional people. Based on an established Bioscience campus in Cambridge, you will have the opportunity to work with smarter science, unique technologies and highly experienced scientific leaders.
Manage clinical supplies packaging, labelling, storage & distribution operations in-line with clinical trial requirements.
Work with CMO partners, clinical operations and clinical site representatives to determine packaging configurations.
Collaborate with medical, clinical operations and CMO partner(s) to lead forecasting including drug demand & supply planning, overages, tracking of usage etc.
In collaboration with analytical services and CMO partners develop and manage storage and shelf-life strategy including oversight of expiry extensions/relabelling exercises as required.
Manage depot stocks, import licences, and importer of record via liaison with CMO partner(s) and clinical CRO(s).
Work with clinical operations, drug product development and clinical site representatives to define processes for dose preparation, labelling and delivery at site.
Significant experience of Clinical Supplies management
Proven track record of managing CMOs to ensure optimal delivery to time, cost & quality.
Experience in maintaining CMC documentation within a QMS and/or eTFM.
Exceptional communication, organizational skills & project management skills.
Knowledge of cGMP/cGCP and related regulatory guidelines governing the manufacture and clinical trial use of biologics
Can you see yourself being part of a company that celebrates diversity and believes that better thinking and decisions come from wider experience? If the answer is yes and you have a desire to be an integral part of a dynamic team, we would be keen to hear from you.
In the first instance, please send your CV to Drew Jones: firstname.lastname@example.org. We endeavour to come back to you within 24 hours of CV submission.