Responsibilities:
You will ensure that the knowledge of setting up GMP manufacturing operations for cell and gene therapy processes are transferred to clients and implemented into their onboarding programs. You will provide Client Support, Cross Site support as well as Operations Support:
Client Support & Cross Site Support (similar duties as below at another site)
- Provide operational/manufacturing support to new clients during On Boarding in accordance with the principles of client model. This could include a “secondment” into the client team for a pre-defined duration to support the client with activities related to accelerating their On Boarding project timelines and RFT licensure, such as:
- Support GMP activity for the manufacture of ATMP’s to facilitate technology transfer, equipment set-up / qualification and process qualification.
- Perform ATMP manufacturing for clinical trials and ensure all manufacturing activities are undertaken in accordance with production requirements and GMP regulatory and quality standards.
- Assist in the generation of GMP documentation including BMRs, equipment SOPs, Logbooks, User Requirement Specifications, IOQ & PQ protocols, Change Controls, Non-Conformances and Risk Assessments.
- Lead activities related to developing Processes/Module layout supporting collaborators.
- Generate SOPs for client activities related to processes specific to the shared areas / responsibilities across site, such as material management and material transfer processes, people and waste flows.
- Create training assessments and support training of client staff in the company’s processes.
- Provide subject matter expertise in Waste Management and HPV systems (generators and chambers – operation and troubleshooting).
- Support the technical upskilling of the Technical Services team in operational improvements using tools such as RCS, 5 Why’s, process mapping and operational processes such as production Waste Management and HPV systems.
- Facilitate the delivery of process improvements through the application and use of OE tools.
- Facilitate the proactive review of existing SOPs/Policy documents
Experience:
- Manufacturing experience in a Pharmaceutical / Biotechnology or other highly regulated environment, with extensive knowledge of current GMP rules and applicable regulatory guidelines.
- Experience in the manufacture of Biological Products is essential, with a knowledge of Up Stream or Down Stream processes and technology preferred
- Minimum 3-5 years’ experience in a scientific laboratory role.
- Minimum of 3 years’ experience working in a regulated environment (GLP/GCLP/GMP).
- Experience in viral vector or cell-based manufacturing environment is preferred.
- Experience of working in a Grade B/C cleanroom production environment.
- Understanding of GMP, ATMP, and EUTCD regulations.
Knowledge / Skills / Competencies:
- Excellent planning, organisational and time management skills.
- Good communication and presentation skills.
- Self-motivated with strong initiative and drive.
- Good working knowledge of Environmental, Health & Safety regulations and Quality Systems.
- Good working knowledge of Lean Manufacturing principles.
- Ability to prioritise effectively and work to tight deadlines.
- Ability to problem solve and make informed decisions.
- Excellent technical writing skills and a high level of attention to detail.
- Ability to build strong relationships with key stakeholders (senior management, collaborators, peer group).
- Excellent team player.
- Personal drive to help push the sector to be a commercial success.
- Willingness to travel. Must be flexible to travel between locations, as required, to support business needs.
Education / Qualifications:
- Science degree or equivalent in Biology, Chemistry, Microbiology or other Life Science Biotechnology / Pharmaceutical sector related subject.
Company Overview:
The company’s aim is to advance the cell & gene therapy sector to make the UK the place to commercialise these life changing therapies. They have the capabilities to take a therapy from the discovery phases, across the translational gap to the clinic and then through clinical trials to launch. Using their R&D expertise to achieve this along with their drive for innovation and continuously adopting the latest and most effective approaches. To completement their R&D efforts they have world class clinical operations, regulatory, health economics and market access expertise. Added to this they have developed a unique and highly successful GMP manufacturing facility based in Stevenage where collaborators can manufacture their therapies for clinical trial and commercial use.
They have a strong culture that is focused on collaborative and innovative working to deliver these life changing therapies to patients. As a company they offer excellent career development opportunities through their L&D programme that not only gives you the skills to advance your career but creates opportunities to take the step forwards to utilise them in a new position. Added to this they are continuing to expand as the demand for their expertise increases and they explore new areas of the sector.