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Operations Lead

The Operations Lead is responsible for providing leadership, supervision and oversight of day to day GMP facility operations processes and activities as well as supporting the Supply Chain and Operations Manager in safety and quality compliance, Collaborator relationship management, and process improvement across the GMP warehouse and operational areas of the CGT Catapult Manufacturing Innovation Centre (MIC) in Stevenage. Additionally, the Operations Lead will have visibility of operational oversight of the (e.g. Digital and Automation Testbed (DAT) labs) working closely with the Scale Enabling Technology (SET) group to realise the potential of this area of the facility. 
Leading the GMP Operations team, and deputising for the Supply Chain and Operations Manager as required, the Operations Lead will ensure standards within the CGT Catapult MIC GMP facility are maintained and will provide the operational interface between CGT Catapult and Collaborators, as well as work and collaborate with cross-functional teams within CGT Catapult to drive efficiency, optimise processes, and execute on operational strategy. 

Key Responsibilities

  • Manage and lead the GMP Operations team including recruitment and selection, motivation, training & development, appraisals and managing performance 
  • Deputising for the Supply Chain and Operations Manager as required  
  • Responsible for safety, quality compliance, and the operational processes and activities across the GMP shared areas of the MIC including oversight of pre-GMP spaces (e.g. DAT labs) 
  • Lead quality compliance and safety investigations, including root cause analysis and CAPA identification and implementation across GMP Warehouse and Operational areas 
  • As the key operational point of contact for Collaborators within the CGT Catapult MIC, build and maintain strong operational relationships and communication channels enabling efficient escalation and query resolution as required  
  • Enable the upskilling of team members in quality compliance investigation root cause analysis, problem solving techniques and safety assessments as appropriate 
  • Ensures GMP Operational team presence and CGT Catapult oversight within the CGT Catapult MIC 
  • Manage the third-party facility cleaning service and waste removal providers, ensuring compliance with associated regulations and standards and in accordance with internal budgets 
  • Feed into and support the Project and Planning team with scheduling and execution of GMP facility operations through accurate resource and capacity planning 
  • Support the Supply Chain and Operations Manager in KPI trending and data analysis to improve the processes and systems across GMP warehouse and operational areas 
  • Accountable for ensuring procedures across the GMP operational areas and pre-GMP spaces are compliant and tailored to business and Collaborator needs  
  • Work with Collaborators within the CGT Catapult MIC to identify areas of improvement across operational functions and implement identified changes in a compliant, timely and cost-efficient manner 
  • Generate, review and approve GMP and pre-GMP documentation such as Standard Operating Procedures  
  • Support the Supply Chain and Operations Manager in embedding and driving a strong safety, quality and continuous improvement mind-set across the GMP Operations teams 
  • Scope and lead change controls where required within area of accountability 
  • Support the Business Development team in scoping new business projects and opportunities for the CGT Catapult MIC 
The above is an outline of the tasks, responsibilities and outcome required of the role; the Operations Lead may be required to undertake other duties as reasonably required as the CGT Catapult MICs evolve under the dynamic CGT Catapult business strategy. 
Experience: 
  • Proven experience of working in an operational role in a GMP manufacturing environment, preferably within advanced therapy/biopharmaceutical industries 
  • Experienced line manager 
  • Demonstratable experience in managing safety in a GMP environment including authoring and approving associated risk assessments.  
  • Experience leading root cause analysis investigation and CAPA implementation in a GMP environment 
  • Experience of managing change within a GMP environment 
  • Demonstration of effective utilization of continuous improvement concepts i.e. LEAN, DMAIC and Six Sigma within a GMP environment 
  • Experience working with external clients and Collaborators 
  • Proven experience of managing projects, budgets and resources 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 

Skills, Knowledge and Expertise

  • Extensive working knowledge of GMP applying EU / MHRA, HTA, HFEA and/or FDA manufacturing regulatory requirements is essential  
  • 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 
  • Self-motivated with excellent interpersonal, communication and presentation skills and the ability to prioritise effectively and work to tight deadlines  
  • A “roll your sleeves up” hands-on attitude towards varying work assignments 
  • Resilient, with the ability to manage multiple and varied tasks and prioritise workload for self and others within a fast-paced professional environment, with a strong attention to detail 
  • Flexible and pragmatic, able to learn quickly and respond flexibly to project needs and priorities  
  • A good team player with a hands-on approach, and adaptable to new challenges 
  • Ability to work well under pressure, to work independently and to be able to take the initiative when completing tasks 
  • Comfortable operating autonomously once goals and objectives are set 
  • Ability to solve problems and make informed decisions 
  • Excellent technical writing skills and a high level of attention to detail 
  • Project ownership and pride in its delivery  
  • Having a passion for delivering excellent service in a cost-effective way  
  • Able to evaluate complex situations and find solutions for them in a professional manner  
  • Excellent people skills with the ability to interact with a wide range of customer needs and the ability to engage constructively with colleagues at all levels across different departments to deliver objectives  
  • Ability to quickly establish credibility and build rapport and trust  
  • A positive attitude towards learning, personal and professional development.  
  • Having current and up to date professional knowledge, expertise and best practice 
  • Willingness to travel. Whilst anticipated that this role will be based primarily at the CGT Catapult SMIC, the Operations Lead must be flexible to travel between locations as required to support the business strategy  
Education / Qualifications: 
  • Degree in a relevant pharmaceutical / biological discipline or relevant industry-based experience