Head of Production

Job overview

An exceptional opportunity has arisen to provide Production leadership as Head of Production within the purpose built Medicines Manufacturing Centre (MMC). Based in Seaton Delaval, Northumberland, the MMC will produce sterile injectable medicinal products in line with MHRA Good Manufacturing Practice on behalf of the North East and North Cumbria Provider Collaborative. The post holder will act as Head of Production, you will provide strategic, professional and operational leadership for all pharmaceutical production activities at the centre. You will be responsible for establishing and maintaining safe, effective and efficient manufacturing operations that meet patient needs and comply with the requirements of Good Manufacturing Practice, the Medicines and Healthcare products Regulatory Agency and the centre’s pharmaceutical quality system.

This is a rare opportunity to lead production within a new NHS medicines manufacturing facility. You will shape the operating model, build and develop the production workforce, implement robust production systems and lead the transition from facility commissioning and validation into routine licensed manufacture.

Working closely with the Managing Director, Head of Quality and senior leadership team and regional partners, you will ensure the reliable manufacture and supply of high-quality medicines for patients throughout North East and North Cumbria.

Main duties of the job

The Head of Production will:

• Provide strategic and operational leadership for all pharmaceutical production activities within the Medicines Manufacturing Centre.
• Ensure that medicines are manufactured safely, consistently and in accordance with the product specification, MHRA specials manufacturing licence and applicable regulatory requirements.
• Lead the development, implementation and continuous improvement of production policies, procedures, standard operating procedures and manufacturing documentation.
• Establish a safe, compliant and high-performing aseptic production service.
• Support the commissioning, qualification and validation of the facility, cleanrooms, utilities, equipment, computerised systems and manufacturing processes.
• Lead production readiness activities and the transition from project delivery into routine operation.
• Develop capacity, demand and production plans that meet the requirements of NHS organisations across North East and North Cumbria.
• Lead the introduction, scale-up, validation and transfer of new products and manufacturing processes.
• Ensure that production activities comply with current Good Manufacturing Practice and relevant medicines legislation.
• Recruit, lead, develop and retain a competent multidisciplinary production workforce.
• Manage delegated budgets, workforce resources, equipment and production assets effectively.
• Represent the Medicines Manufacturing Centre during regulatory inspections, audits and assurance reviews.

Detailed job description and main responsibilities

• Responsible for the management of the Licensed Aseptic Manufacturing Services encompassing staff, resources, activity and information.
• In conjunction with the Head of Quality the Head of Production maintains the MHRA licence(s), liaises with regulatory authorities, receiving and assessing complex information that may affect manufacture of medicines.
• To utilise negotiating skills in discussion with Business Managers, Finance Director(s), workforce planning and ICS partners in regard to business and service development.
• To hold regular senior production management meetings to motivate senior staff and monitor /review:-- Personnel / staffing changes / training records and needs/ sickness /error reports- Health and Safety / Accident and Incident reports
• To attend the Quality Management Meeting, ensuring appropriate pharmaceutical quality systems are in place in all departments of the NENE Provider Collaborative Aseptic Hub.
• To liase with QC and QA personnel on a regular basis to ensure compliance with Good Manufacturing Practice.
• To represent the Hub, as required, attending National and Regional Meetings as required by NHSE, ICS and associated National Working Groups
• To provide information, when required, to nursing and medical staff on optimum formulations for stability of all products prepared in the NENC Aseptic Hub.
• To maintain awareness and knowledge of industry development and best practice.
• Ensuring that comprehensive and up-date selection of reference texts and journals is maintained.
• To maintain and further develop where appropriate links with relevant professional bodies and organisations e.g., Royal Pharmaceutical Society, MHRA, Department of Health and Social Care.