Our client a leading Pharmaceutical manufacturer is looking to appoint a Head of Technical who will
take responsibility for the reliable, efficient and compliant operation of the Technical Department (Technical Manufacturing, Technical Packaging and Artwork), ensuring the routine GMP compliance and efficient operation. This is a really exciting time to join their business as they look to extend their portfolio and their premises making room for more manufacturing and packaging lines.Provide Subject Matter (SME) Expertise in Technology:
The position holder will ensure a scientific approach is taken in the development and change management of packaging materials, product formulation/manufacture/packaging and cleaning.
Technical Operational Effectiveness:
To provide oversight and direction on initiatives that guarantee effective artwork, packaging & manufacturing operations, e.g. Packaging & Manufacturing Batch Record generation, Supplier Management (selection, complaints etc., but excluding purchasing), determining scale of manufacture and campaign strategies, monitor process variables and determine control measures.
Operational Leadership:
To work with the operational leadership team to ensure a safe, complaint efficient and cost effective production operation.
EDCS Effectiveness:
Providing guidance, expertise and support for the strategic technology interface between EDCS Sites, Pharmaceutical Science Technology (PST), Third Party Operations (TPO) and Core Functional Units (CFU) during the development, registration and introduction of pharmaceutical products to ensure effective supply of existing products and successful execution of product launches. Ensure processes are aligned to global expectations.General Responsibilities ( Safety, Quality, Customer, Cost and Innovations
To ensure that operations conducted are performed in accordance with the requirements of Corporate Standards, Quality System, GMP and GDP Guidelines and Industry Standards. Duties are performed to ensure:A safe working environment is maintained for self and other employees, ensuring all near miss incidents and accidents are reported in accordance with procedures.The Quality of products manufactured and released is assured through adherence to all procedures.Opportunities to improve operations and reduce cost are identified and progressed through the continuous improvement and demand innovation initiatives.Philosophy of hhc is at the forefront of daily activities.All stakeholder and customer expectations are understood and met through communication.Performance is in line with personal and Eisai objectives with demonstrated behaviours and competencies.
This position has working relationships with the following:Work with other Operational Leadership Team (OLT) members in an efficient, collaborative and agile way to successfully manage operations on a rolling 12 months to ensure a quality product is provided to the patient when required.Support the Production Director and the Senior Leadership Team (SLT) in the development and delivery of long-term (> 1 year) strategic capital and headcount plans.Pharmaceutical Science Technology (PST) Group, Product Champions (PC) and 3rd Party Operations (TPO) during development, registration and introduction of pharmaceutical products globally; to ensure uninterrupted supply of existing products and successful product launches.Project Sponsors & Stakeholders; to ensure project achieve their objectives.Regulatory; to support Regulatory submissions and generation of filing documents.External parties/suppliers both Company and non Company to support all areas of the relevant element.Management and staff; to ensure a multi-discipline approach to problem solving, continuous improvement and project delivery.The global manufacturing network (Japan, USA and regional 3rd Party Operations); to establish global procedures, support tech. transfers and management of CMOs as required.
Departmental Management:Responsible for compliance to Health and Safety procedures in areas of responsibility by ensuring all activities undertaken by the group are done so in a safe manor with relevant risk assessments in place.Responsible for compliance to Good Manufacturing Practices in areas of responsibility. In conjunction with other functions, design, implement, monitor and maintain the Quality Management System.Key player in internal, customer and regulatory audits.Ensure approved technical standard operating procedures (SOPs) are implemented.Ensure that the required initial and continuing training of departmental personnel is carried out and adapted according to business need.Responsible for regular 1-1 meetings, coaching and review of development opportunities of all direct reports.Develop departmental budget (1 year) and headcount (2-5 year) business plans and to manage departmental expenditure within agreed budgets as well as actively contribute to the capital investment plan.Day to day co-ordination of your department including performance management, KPI’s and metrics management for projects, initiatives and tasks.Ensure Pre-audit Inspection readiness and Knowledge share.Technical & routine operational support of Manufacturing & Packaging operations, systems & process.In conjunction with other functions, identify and facilitate continuous improvement opportunities that result in cost savings and more efficient and compliant ways of working.Set cross functional objectives and lead cross functional teams to deliver change within the business.
Provide Subject Matter (SME) Expertise in Packaging, Material Science & Product Formulation:Development of the Technical capability of the Manufacturing & Packaging teams through technical leadership, guidance and mentoring.Plan and execute artwork development, changes and approval in accordance with registered requirements and local requirements.Planning and execution of process development, comparison and confirmation batches.Support of business development and commercial projects. Chair appropriate committees and provide sponsorship of projects.Define and lead development and execution of Process validation studies.Define and lead Site Cleaning Validation procedures in Manufacturing and Packaging.Define and manage packaging and product material changes.Write, review and contribute to module 3 regulatory filings for manufacturing process development and validation.Strategic Legislation review on Process and artwork related guidance to ensure that there is consolidated understanding of the requirements - Risk assessments, PV and CV, Continued Process verification and artwork.Investigation / root cause analysis for deviations, including Corrective Action & Preventative Action (CAPA) plans.Investigate new technologies that would support the future of EDCS’s business.Support compliant Critical Device Assessments and Lists for production equipment.Support the specification, selection, implementation and qualification of new equipment and technology into company.
Operational Effectiveness:Working cross functionally with the operational leadership team to lead the manufacturing and packaging operation. To ensure smooth and compliant operation of the packaging & manufacturing processes.To identify quality related trends and facilitate the implementation of corrective actions.Creation and change management of Packaging & Manufacturing Batch Records.Responsible for the management of manufacturing/packaging technical activities (change management, deviation investigation, corrective & preventative actions (CAPA) management, root cause analysis and complaint investigation).Contribute to the definition and delivery of Quality Risk Assessments.Support Supplier Relationship Management and issue resolution arising from technical and quality performance.
EDCS Effectiveness:Define Manufacturing & Packaging Performance Qualification & Process Validation procedures.Liaise with Global Functional groups to ensure knowledge share of best practice.Technical support and facilitation of affiliates, TPO & supply chain.
Skills and QualificationsExperience in leading and managing a team.Experience in pharmaceutical industry.Applicable science-based degree.Applicable technical knowledge and good technical writing ability.Project management experience desirable.Experience in and can apply change management models.Demonstrable familiarity of MHRA/EMA/FDA guidance
CompetenciesStrong at motivating and leading a team.Coaches and develops direct reports and others in team.Professional behaviour, self-aware and can build great team culture.Excellent communicator who can flex styles for differing target audiences.Can problem solve and remain calm under pressure.Great at prioritising and giving clear direction.Self develops ensuring they keep up to date with the times and changing technologies, helping to set long term vision.Strong influencer.Has a constant improvement mindset.
