FUJIFILM Diosynth Biotechnologies
Fujifilm Diosynth Biotechnologies is investing £400M to introduce a new, state-of-the-art biomanufacturing facility. This biomanufacturing facility will provide additional Cell Culture and Viral Gene Therapy cGMP manufacturing capacity to the existing Billingham, UK campus and is expected to become operational in 2025.
We are a trusted CDMO partner for life. At FUJIFILM Diosynth Biotechnologies (FDB), we encourage you to discover what inspires you every day, to follow your passion and your power – what we call Genki.
The work we do has the potential to transform people’s lives and to impact where it matters most. Each day is an opportunity to push the boundaries of your potential, so join us and become part of a fast-growing global company, united by Genki.
About Us
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.
Role & Responsibilities
Initially the job role will be acting as QA on the implementation of the new manufacturing facility, working on implementing new systems, processes and procedures, once the manufacturing facility is live and operational it will be transitioning to a business as usual role proving QA oversite on the manufacture of GMP products to ensure compliance throughout the process life cycle.
- Manage the compliant delivery of designated elements of the business Sales and Operations Plan (S&OP).
- Build and maintain good working relationships with key stakeholder functions and any other departments/individuals as required.
- Evaluation of recommendations and make final decisions, but where appropriate identify escalation requirements with further recommendation to senior management.
- Identification, assessment and mitigation of risk with escalation of high residual risk.
- Ensure self and team (including line reports) have no overdue training, or site actions. Support other QA teams and other functions within area of direct influence, in completion of site actions.
- Manage, motivate, train, and coach, any direct reports to ensure assigned Quality Assurance (QA) and personnel development objectives are achieved within agreed time-scales. Identify potential candidates for succession plans.
- Able to coach/train personnel of non-QA roles, in the application of GMP Principles including the underlying rational of those principles.
- Demonstrate Subject Matter Expertise (SME) in more than one QA System
Qualifications and Experience
- Chemistry/Microbiology/Biochemistry degree or a related subject or equivalent experience
- A minimum of 5 years’ experience in a GMP/GLP environment
- Applied Knowledge and proficiency of QA systems: (for example
- Events/Deviations, CAPA’s, change control)
- Demonstrate a sound knowledge of how the principles and practices of GMP are applied to areas of responsibility.
- Demonstrate capability to deliver change and continuous improvement objectives.
- Experience in line management
Why work with us?
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 30 August 2024
PS - QA Associate Manager
JD - QA Associate Manager