About this role
Job summary
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.
About us
We manage three major locality hospitals at North Tyneside, Wansbeck and Hexham, plus a number of smaller community hospitals and clinics from Tynemouth to Berwick on Tweed, covering one of the largest geographical areas of any NHS trust in the country. Leading in innovation and quality - opening a state of the art Northumbria Specialist Emergency Care Hospital, the first of its kind in England. Do you want to work in one of the best performing NHS organisations in England? Work in an organisation that supports its staff and focuses on staff experience as much as it does the experience of its patients? You can live and breathe in an area that has the cleanest air, cost effective living, great nightlife, some of the best schools with a wealth of history available on your doorstep. Sound too good to be true? Well it isn't, this is what you get when you work for Northumbria Healthcare, this is the Northumbria Way! Please read 'applicant guidance notes' before submitting your application.
Job description Job responsibilities
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.
Person Specification
Qualifications 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
Experience 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.
Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details Employer name Northumbria Healthcare NHS Foundation Trust
Address Northumbria Healthcare Manufacturing and Innovation Hub
Avenue Rd
Seaton Delaval, Whitley Bay
NE25 0QJ
United Kingdom
Employer's website https://www.northumbria.nhs.uk/ (Opens in a new tab)