Head of Production

• 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.

• Responsible for the management of the Licensed Aseptic Manufacturing Servicesencompassing 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 andSocial Care.

Essential

• Masters degree in a scientific / engineering discipline or equivalent experience
• Registered Professional
• Post-graduate qualification in Pharmaceutical Manufacturing or equivalent experience

Desirable

• Postgraduate diploma in Pharmaceutical Technology and Quality Assurance
• Management qualification

Essential

• Advanced theoretical and practical knowledge, gained through training, of technical areas of pharmacy, including pharmaceutical manufacturing, preparation, procurement and contracting, auditing and unlicensed medicines.
• Good knowledge of MHRA Guide to Good Manufacturing Practice, and the British and European pharmacopoeial requirements for raw materials, intermediates and finished products.
• Evidence of successful team management
• Evidence of a leading role in an MHRA Regulatory inspection

Desirable

• Awareness of policies and procedures which impinge on role
• Budgetary planning / financial management experience
• Awareness Corporate and Clinical Governance; Control Assurance Standards within NHS.
• Detailed knowledge of the manufacture of parenteral nutrition, cytotoxic chemotherapy, intravenous additives, Homecare.
• Microbiology/formulation/product design, and the chemical, pharmaceutical and clinical properties of ingredients
• Expert Knowledge of gassing isolators
• Nationally recognised expert in pharmaceutical manufacture.
• Evidence of leading a successful previous pharmaceutical build.
• Evidence of awareness of the NHSE Aseptic Transformation process.