Operations Lead

The success and growth of the Cell and Gene Therapy Catapult Manufacturing Innovation Centre requires an Operations Lead to supervise operational activities and work with CGT Catapult’s Collaborators operational functions. The purpose of this role is to lead the CGT Catapult GMP technical services team responsible for operational processes and activities across the GMP shared areas of the facility. The Operations Lead will support the development of scheduling systems and tools across operational areas and will line manage the headcount associated with scheduling and planning for the manufacturing innovation centre. It is expected that the Operations Lead will take on a leading role in working with operational departments in developing and managing a continuous improvement program for the manufacturing innovation centre.

Key Accountabilities:

GMP Operations

• Manage & lead the GMP operations and scheduling team including recruitment and selection, motivation, training & development, appraisals and managing performance
• Manage quality records effectively, adhering to internal standards for investigation management and closure
• Manage the third party GMP cleaning service provider and ensure spend is managed according to internal budgets.
• Identify KPIs and build business cases to improve the processes and systems in the GMP shared areas
• Accountable for ensuring procedures across the GMP shared areas are compliant and tailored to business and collaborator needs
• Generate, review and approve GMP documentation such as Standard Operating Procedures
• Serve as out of hours On-call duty manager on a rotational base together with other senior personnel

Scheduling

• Develop robust scheduling systems and processes across all operational areas of the manufacturing innovation centre to support Collaborator organisations as manufacturing increases at scale
• Manage the scheduling function responsible for scheduling activities across the shared GMP areas, warehouse and supply chain and quality control
• Implementation and routine management of the resource planning/project tracking tool for the manufacturing innovation Centre

Continuous improvement

• Work with our Collaborators to identify areas of improvement across operational functions and implement identified changes in a compliant, timely and cost-efficient manner
• Support the Head of Operations in developing and implementing a continuous improvement strategy and governance structure for the manufacturing innovation centre
• Scope projects, develop and manage project plans, timelines, risks and issues and required stakeholders
• Develop detailed and well-defined project scope and pro-actively manage the scope through project delivery
• Provide support to the Business Development team, including activities such as scoping and of new projects that aim to grow the cell and gene therapy cluster in Stevenage

Experience:

• Proven experience of working within a pharmaceutical GMP environment preferably in cell and gene therapy
• Proven experience of working in an operational role in a manufacturing environment
• Experience of managing change and understanding of continuous improvement concepts i.e. LEAN, DMAIC and Six Sigma concepts would be desirable
• Experienced line manager
• Proven experience of managing projects within an operational environment
• Proven experience of looking critically at own and others work practices and procedures and identifying and implementing any needed improvements
• Proven experience of motivating teams, whilst training and acting as a role model for others

Knowledge / Skills / Competencies:

• Highly motivated, pragmatic and practical to support the mission of the Cell Therapy Catapult to accelerate the development of a commercial cell and gene therapy-based therapy industry in the UK Resilient and able to work well under pressure, able to prioritise a heavy workload and work both reactively and pro-actively
• A flexible approach to work assignments. An ability to manage multiple and varied tasks and to prioritise the workload whilst maintaining a strong focus on accuracy and attention to detail
• Excellent people skills with the ability to interact with a wide range of customer needs
• Strong influencing and leadership skills
• Keeps up to date with professional knowledge, expertise and best practice
• Ability to quickly establish credibility and build rapport and trust
• A good team player with a hands-on approach
• Able to evaluate complex situations and find solutions for them in a professional manner
• Flexible and pragmatic, able to learn quickly and respond flexibly to project needs and priorities
• Resilience, with the ability to work well under pressure, to work independently and to be able to take the initiative when completing tasks and work both reactively and pro-actively
• Project ownership and pride in its delivery
• Flexibility towards work assignments and new learning
• Ability to manage multiple and varied tasks and prioritise workload
• Comfortable operating autonomously
• Excellent interpersonal, written and verbal communication skills
• Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives and to respond to a wide range of customer and management needs
• Ambitious, collaborative, driven
• Willingness to travel, must be flexible to travel between locations as required

Education / Qualifications:

• MSc or BSc in a relevant biological or commercial discipline