We are seeking an enthusiastic, flexible and experienced Cryostorage Operational Lead to join our dynamic team and manage the day-to-day operations of our cryostorage facility.

The successful applicant will be responsible for the operational management of the cryostorage facility. This includes client management for samples and materials stored at the facility.   

The post holder is one of the deputy (Person Designate) to the HTA Designated Individual. They will assume day to day responsibility for all samples stored under the HTA licence.

They are responsible for managing material storage, ensuring that adequate space is always available to meet the business, clients, and regulatory requirements.

The post holder maintains all aspects of quality relating to material storage, and for the oversight of temperature monitoring systems. 

In addition, the Cryostorage Operational Lead is responsible for the day to day management of the facility working closely with the Facilities Team. 

The Company:

hVIVO is a dynamic and pioneering global player in the pharmaceutical early phase research sector. We conduct human challenge studies offering services to both pharmaceutical and biotechnology companies using a range of different clinical trial methodologies. The end goal of our clinical trials is to potentially eradicate common illnesses like the common cold and flu completely – or at least make treatment of them as easy and effective as possible.

The hVIVO Laboratory function undertakes sample processing and analysis for all clinical trials conducted at hVIVO. The Laboratory Team has a diverse work stream including internal studies, clinical trials and standalone projects. The laboratory team also performs bespoke assay development and validation work as well as collaborating with strategic partners.

The successful applicant will be required to carry out the following responsibilities, activities and duties:

• Act as Person Designate, supporting the Designated Individual for HTA Licence.
• Oversee temperature monitoring systems across sites.
• Ensure complete and accurate inventory of all material stored at the facility.
• Liaise with clients and couriers to arrange shipments, packaging and temperature monitoring requirements.
• Ensure compliance with shipment regulations i.e. Controlled Drugs and Cat A Dangerous Goods. 
• Prepare shipment documentation including Customs Invoices, DG notes or Controlled Drug Export Licences.
• Prepare, pack, ship and unpack shipments to and from the facility, this includes completion of the relevant paperwork and discrepancy investigation, as well as checking shipment temperature data loggers.
• Proactively manage storage space and material storage timelines if required. Create plans for material usage and/or destruction at the end of storage life.

Bachelor's degree in relevant field is desirable.

Expert in use of sample and inventory management software.

Understanding of HTA regulations.

Strong organisational skills.

Prior experience working with GxP guidelines.

Prior epxerience in managing facilities is desirable.

Prior experience as HTA Designated Individual or Person Designate is desitable.