Head of Technical

An exciting opportunity to join a growing pharmaceutical business that specialises in oncology and neurology. The Head of Technical 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.

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 in EML to ensure a safe, compliant, 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 EML processes are aligned to global expectations.

Main Responsibilities:

• To ensure that operations conducted are performed in accordance with the requirements of Corporate Standards, Quality System, GMP and GDP Guidelines and Industry Standards.
• A safe working environment is maintained for self and other employees, ensuring all near miss incidents and accidents are reported in accordance with procedures.
• Responsible for compliance to Good Manufacturing Practices in areas of responsibility.
• In conjunction with other EML functions, design, implement, monitor and maintain the Quality Management System for EML.
• 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.
• 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.
• 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.
• Define and lead development and execution of Process validation studies.
• Define and lead Site Cleaning Validation procedures in Manufacturing and Packaging.
• 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.
• 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).

Requirements and Qualifications:

• Experience 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.
• Strong influencer.
• Has a constant improvement mindset.

Please note this is a senior position, so it will require 15+ years of experience and someone willing to travel into the office on a hybrid basis.