Do you have a leadership background from a GMP environment, manufacturing biologics, steriles or ATMP products? Do you have a scientific background that includes cell biology / iPSCs?
We are looking for a highly ambitious, energetic, commercially savvy individual who has set up and / or managed a Production team, to join a pioneering cell therapy organisation in Cambridge. This is a genuinely unique opportunity which will involve building a modern GMP facility, recruiting a production team and working with internal and external partners to ensure efficiency and compliance. Candidates will be considered from other cell therapy organisations, as well as GMP-certified academic / hospital ATMP production facilities.
This is a newly-created permanent position, with a salary up to £65,000 (plus excellent benefits) depending on experience. Your work will be a mixture of site-based and home-based, and you will be tasked with managing a range of projects to scale up production capabilities, working with external production partners in the interim while setting up the internal processes needed to manage manufacturing in-house.
Reporting to the Head of Quality, your role will include:
Leading, inspiring and growing a team of dedicated scientists to establish a state-of-the-art Production team to support manufacturing capabilities.
Promoting a proactive, continual improvement cultureand systems to maintain high standards of service and good practice.
Operational and strategic responsibility for the running of the production team.
Driving innovation relating to human iPSC culture, automation and manufacture.
Working in closecollaboration with other Department Heads (Research, Genetic engineering, iPSC platform, Production, Product Management, Commercial and Clinical translation) to meet scientific, new product launch and clinical objectives.
Liaising with external bodies, collaborators and customers on any Production-related matters.
Working with internal stakeholders (Product Management, Business Development teams etc) to schedule, resource and execute production activities and ensure efficient capacity utilisation.
Engaging with the academic and industry scientific community to promote and diversify the company’s Manufacturing activities.
Providing scientific leadership in the development of production processes, including transfer into GMP, leading route cause analysis and in the development of SOPs.
Supporting the delivery of production projects by overseeing their planning, execution and analysis of results.
Coaching and mentoring of junior members of the team by providing intellectual and practical support and ensure group training needs are met.
Establishing, monitoring and reporting key performance data to the Head of Manufacturing e.g. production schedules, group capacity, progress against targets and failure rates.
Benefits:
In addition to a generous basic salary, the company offers the following benefits package:
30 days holiday
5% match contributory pension - after three months
Private healthcare - with Vitality (the highest level of cover you can get) after three months
Life assurance
Cycle to work scheme
Electric car scheme - coming in soon
Skills and Experience Required:
Strong experience of running production activities for either biologics, steriles or ATMP products
Life science qualification – ideally a PhD related to stem cells
Detailed knowledge of GMP
Excellent communication skills and ability to work with people at all levels
Proactive, driven, pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
Full details will be provided on application. This is a permanent role in Cambridge, Cambridgeshire, and you will have a mix of home-based and site-based work.