Fujifilm Diosynth Biotechnologies is investing £400M to introduce a new, state-of-the-art biomanufacturing facility. Known internally as ‘Project Borealis’, this biomanufacturing facility will provide additional Cell Culture cGMP manufacturing capacity to the existing Billingham, UK campus and is expected to become operational in 2025. For Project Borealis, there are 2 phases to the role; in phase 1 the successful applicant will join the Borealis project team and contribute to the set up of the facility, participating in preparation activities to ensure Borealis is operationally ready for December 2025. We are a dynamic global company and our focus is to combine technical leadership in cell culture, microbial fermentation and gene therapies with world class cGMP manufacturing facilities to advance tomorrow’s medicines. With sites in Billingham & Wilton UK, Hillerod Denmark, North Carolina and Texas USA, the size and breadth of our business will open up huge opportunities for you, whether you want to move to a different role in the UK, relocate, or progress and take on more responsibility. Our teams are proud to partner with innovative companies reimagining what’s possible in biopharmaceuticals. Every day at FDB is a day for improvement, each challenge is an opportunity for growth, and every moment is a chance to evolve together. During phase 1 the role will be day shifts Monday – Friday. Once the facility 'goes live' in phase 2, the Lead Production Technologist role will be responsible for leading a team in either USP and/or DSP processing, ensuring batch activities are completed on time in a safe and compliant manner whilst supporting other members of the team with troubleshooting, training and acting as first point of call for any process deviations. During phase 2 the successful applicant will step onto working shifts with their designated team. Principal Accountabilities 1. Demonstrate ownership and leadership within the manufacturing environment by ensuring relevant EHS and GMP standards are continually maintained. The job holder will lead by example and demonstrate the ability to challenge and change unacceptable practices to continually improve ways of working in manufacturing. 2. Has extensive knowledge of the manufacturing process and operation of associated production equipment, acts as the primary manufacturing contact throughout the lifecycle of Technology Transfer and process execution (GMP preparation, manufacture and batch disposition). 3. Collaborates within programme teams to create all documentation required to execute a manufacturing process, ensures processes transferred to the manufacturing facility are designed to operate safely and compliantly. 4. Creates, monitors, executes, adjusts, and communicates manufacturing plans and co-ordinates associated production team resource to achieve manufacturing schedule targets. 5. Provides appropriate decision making and assessment of impact on product quality through a thorough understanding of the theoretical concepts and principles relating to cGMP manufacture. 6. Leads process related investigations in collaboration with development and engineering teams to establish the root cause of failures. Degree in biology, biochemistry, microbiology or other related subject NVQ in Plant Process Operation Grade C or above for GCSE English and Maths Experience of working in a GMP environment or regulated environment Minimum 2 years’ experience co-ordinating resource to support day to day activities to achieve business objectives. At FDB, your passion – your Genki – is your power and we empower you to define what Genki means to you. When you join us, we will train, develop and support you to become the best you can possibly be. We offer a structured new starter induction programme as well as on-going development training. In addition to this, we offer: Competitive salary plus company bonus scheme 35 days of holiday, plus bank holidays. Salary Sacrifice scheme offering, healthcare, bikes, dental etc. Generous pension scheme Free parking and electric charging points Closing date 10th January 2024 JD - Lead Production Technologist Lead Production Technologist PS