Head of Operations

2 months ago

Darlington, United Kingdom Centre for Process Innovation Full time

**About **CPI**
CPI helps make great ideas and inventions a reality. We’re a team of intelligent people using advances in science and technology to solve the biggest global challenges in healthcare and sustainability.
Through our incredible people and innovation infrastructure, we collaborate with our partners in industry, academia, government, and the investment community to accelerate the development and commercialisation of innovative products.
From health technologies and pharmaceuticals to sustainable food and materials innovations, we turn the entrepreneurial spirit and radical thinking of our people and partners into incredible impact that makes our world a better place.

**Why this role is important for CPI’s work**
An exciting opportunity has arisen for a Head of Operations role at CPI’s National Biologics Manufacturing Centre (NBMC), based in Darlington.
The state-of-the-art Biologics and RNA manufacturing facility in Darlington is a key part of CPI’s organisation, housing a wide range of scientists and engineers tasked with innovating, de-risking, and delivering a broad spectrum of novel biological medicines in the UK.
You will be joining a lively, enthusiastic, and friendly team supporting the scientists and managers on-site working on a variety of biologic formats, from antibodies to viral vectors and RNA, leveraging your process expertise to deliver the best outcome for our partners. You will have the opportunity to develop your experience and career in a stimulating and forward-looking environment.
Reporting to the Director of Biologics & RNA Centre of Excellence, you will provide operational and technical leadership to the established Operations team members to work in full compliance with our licence to operate ensuring we maintain a safe, secure, and compliant organisation and facilities.
Through knowledge of Laboratories or Biologics and Pharma manufacture, you will offer innovative Facilities Management, Safety, and Validation solutions at business-unit level, contributing extensively to development and improvement activities.
You will be responsible for:
**Facilities Management**
- Manage and maintain the laboratories, utilities, and equipment used in them ensuring the availability of all facilities for all projects scheduled in line with project timelines and budgets
- Manage building maintenance, modification, and repair activities for Biologics in conjunction with our central support services (Facilities Management & CBRE).
- Ensure that the facility is kept in a state of compliance with statutory, ISO, and GMP regulatory requirements where needed.
- Liaise with Facilities Management (FM) & CBRE to manage works needed above and mitigate key risks associated with safety and compliance.
- Ensure that all necessary inspections, surveys, and assessments are carried out and that planned maintenance programmes are carried out in liaison with our contractors (FM & CBRE) - to include all critical utilities and systems (ie pressure systems and HAZOP)

Co-ordinate the local administration activities (ie BMS trending, alarms, instrument lists, control of work and work permits, document management, etc)
**Equipment Validation and Engineering Compliance**
- Manage all equipment validation in compliance with CPI engineering standards for new and or modified equipment (Process equipment and Laboratory equipment)
- Own and manage the operations Change Control process (C&M Process).

**Laboratory and plant safety**
- Own, maintain, and manage local Safety Incident management procedures and action plans
- Own, maintain, and manage local BCP and Incident management plans
- Establish and actively contribute to building a Safety Culture within Biologics through:

- Coaching and training staff
- Gemba
- 5S and housekeeping

Some key responsibilities of the role also include the following:

- Maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality, and best practice requirements.
- Provide coaching, feedback, and motivation to team members that enable individuals to meet their full potential. This includes providing strong managerial leadership, performance management, resource allocation, and long-term strategic planning to ensure the successful delivery of both current and future Biologics objectives
- To provide high-quality strategic and budgetary input into the CPI budgeting process.
- To provide the Business Unit Director and Executive Leadership team with operations and GMP technology advice and thought leadership.
- To form solid interdisciplinary links across teams to ensure a seamless incorporation of operations and GMP science technology knowledge and tools at the appropriate point in project development.
- To utilise own expert knowledge to assist in translating business unit strategy into practice through the delivery of plans to set and achieve team and business unit objecti

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