Jason at CK Science is recruiting for an Associate Director of Supply Chain & Logistics to oversee the implementation and execution of Supply Chain and Logistics Operations to support commercialization of our client's products. Such activities will include the design and implementation of integrated processes and procedures for the coordinated accession, manufacture, storage and distribution of the company's cryopreserved autologous, hematopoietic stem cell-based gene therapy products and starting materials.
Since conception in 2015 the company has grown into a leading global, fully integrated commercial-stage company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies. With over 100 people globally, based across three locations in the US & UK, it is a fast paced, start up environment that is privately held and was named a Fierce 15 Company by FierceBiotech in 2016.
You will design and implement processes and procedures to ensure effective and compliant clinical and commercial supply chain operations whilst leading coordination with Technical Operations, Clinical and Commercial Departments. You will be responsible for scheduling the harvest, packaging and collection of patient samples, the delivery of critical raw materials to the designated manufacturing location, the manufacture and release of autologous gene therapy product, the packaging, collection and on time delivery of the autologous gene therapy product from the manufacturing facility to the designated hospital/clinical center for the scheduled patient administration and the administration of the autologous gene therapy product to the patient.
You will oversee service agreements/contracts and manage logistics for the packaging, collection, tracking and cold chain delivery of autologous bone marrow, cryopreserved autologous, hematopoietic stem cell-based gene therapy and peripheral blood product harvests. You will also ensure that Import/Export documentation is available, collaborate with Quality Assurance and other relevant departments, conduct the investigation, reporting and closure of deviations and associated CAPAs, develop Key Performance Indicators for supply chain activities, trend data and provide recommendations for improvements and cost reduction to senior management.
Based in London this role is offered on a full time permanent basis and the position comes with a comprehensive compensation package tailored around you.
It is essential that you have experience in clinical and commercial supply chain management preferably with cell and gene therapy products. You will hold a proven track record of supply chain planning, materials/inventory management, and business process facilitation, including experience with supplying global clinical trials and commercialization, the management of vendors for Cold Chain Storage, Packaging, Tracking and Distribution and experience importing and exporting human cell and gene therapy products for use in clinical trials. Cell and gene therapy product experience is a plus but you will need an in-depth knowledge of import and export requirements and of FDA, EMA, GMP, GCP and ICH regulatory requirements.
The ideal candidate will have experience working within the rare disease field in combination with cold chain supply.
If successful you will be working in partnership with the world's leading research centres to harness the life-giving potential of gene therapy and striving to make the company the leader in gene therapy for primary immune deficiencies and inherited metabolic disorders. If you are passionate about transforming the lives of patients with rare disorders this is the right place for you.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST42992 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Jason Johal
- Phone: 01438 723 500
- Reference: ST42992
- Posted: 2nd August 2018
- Expires: 30th August 2018