Detailed job description and main responsibilities

To lead development and formulation of new and existing pharmaceutical products across all areas of Newcastle Specials to meet the needs of Trust patients and our customers and commercial partners.

• To include development of Sterile, Non Sterile and Aseptic Products
• The development of Investigational Medicinal Products
• The development of contract manufacturing opportunities
• Perform ongoing review and development of Newcastle Specials product range

To ensure concepts of Quality by Design (QbD) are applied throughout product and process development and improvement cycles

To ensure all aspects associated with Pharmaceutical Development, Quality Risk Management and Pharmaceutical Quality Systems are considered and applied throughout product development and translation to final product manufacture or preparation

To ensure all final products are manufactured/prepared in accordance with GMP, GDP, GCP and EL guidelines, relevant SOPs and other regulations

To develop New Product Introduction Strategy, the focus of which is to coordinate quality and production departments to enable timely introduction of new products

• identifying Target Product Profile (TPP), Target Product Quality Profile (TPQP)
• Identify Critical Quality Attributes for new products in development
• design and development of product and manufacturing processes
• co-ordinate assessment and management of risks and control strategy

To project manage and ensure that targets for each product in development are formally and consistently reported on using GANTT charts and other tools to identify milestones and identify and highlight areas that may introduce delay Newcastle Specials & Pharmacy Production Services corrective/preventive actions have been requested and documented effectively, including confirmation that actions have been undertaken to maintain target timeframes

To train Newcastle Specials and Pharmacy Production staff and others as required (either directly or indirectly) regarding GMP, GDP, , QA and regulatory requirements during new product development and implementation

To ensure that Regulatory audits are effectively executed and provide support and direction during the hosting of such audits as necessary

To assist the Assistant Chief Pharmacist –Production and Preparation in the implementation of quality, financial and development initiatives

To maximise at all times the utilisation of production staff, time and facilities identifying opportunities for production/process efficiencies

To evaluate and implement new equipment and technologies to improve
capability or efficiency of manufacturing methods

To deliver a comprehensive and responsive production / preparation service to the RVI and Freeman sites. (Includes Licensed Sterile and Non-sterile Manufacturing, Paediatric CIVA, Chemotherapy, Parenteral Nutrition, Homecare Services)

Job Scope

To undertake a key leadership role within the organisation, being visible and working closely with pharmacy business manager, senior production staff, quality assurance, quality control managers, and senior production pharmacist- clinical trials to lead new product development and introduction.  Work closely with business manager to evaluate feasibility of new product requests

Meets with clients to understand their requirements, defining project plans to ensure timely delivery of manufacturing and analytical requirements

Lead in the development, implementation and monitoring of practice through audit of National and local policies, protocols and guidelines

Prepare reports as required to demonstrate new product development progress and process improvement outcomes to increase portfolio of high quality pharmaceutical products for the needs of our patients and customers

Work closely with the Trust Quality Controller and Assistant Director of Pharmacy – Quality Assurance in the formal quality review of products and production processes

Leads on safe introduction of of prepared/ manufactured sterile and non-sterile medicines in defined unlicensed preparation and /or licensed manufacturing sections across two Trust sites, maintaining safe systems in accordance with Health & Safety and COSHH regulations

Contributes to stock control and reduction in wastage of medicines