The purpose of this role is to support the Goods Manufacturing Practice (GMP) operations of the CGT Catapult Stevenage Manufacturing Innovation Centre (S-MIC). Reporting to the Operations Lead, this is a hands-on role responsible for executing the day-to-day tasks associated with managing, maintaining, and continually improving the operational processes at the CGT Catapult S-MIC, ensuring they comply with the standards and expectations of regulatory authorities, internal policies/procedures and key stakeholders and Collaborators.
- Be the first point of contact between CGT Catapult and Collaborators for operational queries.
- Provide operational oversight within the facility, ensuring that operational procedures and policies are complied with.
- Provide oversight to activities undertaken by the contract cleaning services provider, ensuring that cleaning in all GMP areas comply with quality standards and is executed in adherence to the schedule.
- Ensure operational equipment (e.g. VHP chambers and generators) and processes are maintained in a fit for purpose state.
- Take ownership of operational policies and procedures, ensuring they are fit for purpose and are maintained “in date”.
- Take ownership for ensuring facility logbooks are completed and maintained compliantly in accordance with GMP and data integrity principles.
- Take responsibility for the management of waste, including collection of Human Tissue Waste and Large Volume Liquid Waste, ensuring that waste is packaged, collected, and disposed in accordance with internal procedures.
- Take responsibility for the spills management process at the S-MIC, including being a member of the spills team.
- Perform root cause investigations, GEMBA (observation) walks and reviews of existing processes and systems to drive improvement.
- Develop and deliver training on operational procedures.
- Take ownership for the scheduling of activities within the shared areas and modules. This will include scheduling the movement of material, equipment, product, waste and samples, cleaning and Environmental Monitoring within shared areas and modules to minimise disruption to Collaborators whilst ensuring that activities are executed compliantly.
- Work with Quality Control, Quality Assurance, Engineering, Warehouse personnel, Collaborators, suppliers, and services providers to assist in the maintenance of GMP complaint operations as required.
- Take ownership for developing and maintaining a set of Operational KPIs which enables the performance of the department to be measured and drives continuous improvement.
- Take ownership for managing Quality Records (Non-Conformances, Change Controls, CAPAs) and LIRs, ensuring that they are executed in a timely manner.
- Participate in self-inspections/internal audits involving operational areas, processes, and procedures.
- Support the Operations Lead in preparing and fronting external audits.
- Support the Warehouse team, with the management of inventory related to PPE and cleaning reagents, ensuring that there are no stock outs.
- Escalate risks to management in a timely manner.
- Undertake any other duties as required commensurate with the post.
- 3-5 years’ experience working in a (bio)pharmaceutical manufacturing environment operational role.
- Experience of scheduling in a production or equivalent environment.
- Experience of critically assessing own and others work practices and procedures and identifying and implementing any needed improvements.
Knowledge / Skills / Competencies:
- Highly motivated, pragmatic and practical to support the mission of the Cell and Gene Therapy Catapult to accelerate the development of a commercial cell and gene-based therapy industry in the UK.
- Desire to establish a high profile career within cell and gene sector and the personal drive to help push the sector to be a commercial success.
- Ambitious, collaborative, driven.
- Self-motivated, with a pragmatic and practical approach.
- Able to deliver excellent customer service in a cost-efficient way.
- Flexibility towards work assignments and new learnings.
- Ability to manage multiple and varied tasks, prioritising workload with attention to detail.
- Comfortable operating autonomously.
- High degree of accuracy and attention to detail.
- Good understanding of GMP and cleanroom operations.
- Working knowledge of Lean Manufacturing principles.
- Excellent interpersonal, written, and verbal communication skills.
- Constructively engage with colleagues at all levels across different departments.
- Ability to quickly establish credibility and build rapport and trust.
- Ability to evaluate complex situations and find solutions for them.
- A good team player with strong organisational skills.
- Ability to work well under pressure and to be able to use their initiative when completing tasks.
- Ability to manage multiple and varied tasks and prioritise.
- Proficient with IT systems and applications including MS Outlook, Word, Excel, and PowerPoint.
- A positive attitude towards learning, personal and professional development.
- Keeps up to date with professional knowledge, expertise and best practice.
- Willingness to travel.
Education / Qualifications:
- Bachelor’s degree in Life Sciences(desirable).