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.

Key Responsibilities:

• Provide Subject Matter (SME) Expertise in Technology: Ensure a scientific approach is taken in the development and change management of packaging materials, product formulation/manufacture/packaging and cleaning.
• Technical Operational Effectiveness: Provide oversight and direction on initiatives that guarantee effective artwork, packaging & manufacturing operations, including Packaging & Manufacturing Batch Record generation, Supplier Management, determining scale of manufacture and campaign strategies, monitor process variables and determine control measures.
• Operational Leadership: Collaborate with the operational leadership team to ensure a safe, compliant, efficient and cost-effective production operation.
• EDCS Effectiveness: Provide 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.

Main Responsibilities:

• Ensure operations are performed in accordance with Corporate Standards, Quality System, GMP and GDP Guidelines and Industry Standards.
• Maintain a safe working environment for self and other employees, ensuring all near miss incidents and accidents are reported.
• Ensure compliance to Good Manufacturing Practices in areas of responsibility and design, implement, monitor and maintain the Quality Management System for EML.
• Act as a key player in internal, customer and regulatory audits.
• Ensure approved technical standard operating procedures (SOPs) are implemented.
• Ensure required training of departmental personnel is carried out and adapted according to business need.
• Conduct regular 1-1 meetings, coaching and review of development opportunities for all direct reports.
• Identify and progress opportunities to improve operations and reduce costs through continuous improvement initiatives.
• Develop departmental budget and headcount business plans, managing expenditure within agreed budgets.
• Coordinate daily departmental activities including performance management and KPI’s for projects and initiatives.
• 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.
• Conduct strategic legislation review on Process and artwork related guidance.
• Manage the creation and change management of Packaging & Manufacturing Batch Records.
• Manage manufacturing/packaging technical activities including change management, deviation investigation, and CAPA management.

Requirements and Qualifications:

• Experience in leading and managing a team.
• Experience in the pharmaceutical industry.
• Technical knowledge and good technical writing ability.
• Experience in applying change management models.
• Familiarity with MHRA/EMA/FDA guidance.
• Strong influencing skills.
• Constant improvement mindset.

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