Formulation & Product Development Manager

Job 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 improvecapability 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

Qualifications & Education

Essential

• Masters level qualification or equivalent qualification or equivalent experience in a relevant discipline
• Relevant experience of working in a licensed production unit and/ or unlicensed preparation unit
• Audit of services by external auditing organisation i.e., MHRA and / or Regional Quality Assurance Specialist
• Managing / training staff
• Extensive theoretical and practical experience of governance, audit and policy development in a range of settings to Masters level or equivalent
• Proven experience in a GMP/GDP/GCP environment and/or quality setting , including policy developments
• Experience of preparing for external inspection
• Experience of monitoring compliance with national risk management/quality standards
• Ability to work strategically

Desirable

• Experience as a senior Pharmacist or senior Pharmacy Technician
• Demonstrable staff management
• Policy design and implementation
• Trained in appraisal skills
• S/NVQ Level 3 in Pharmacy Services and approved underpinning knowledge e.g. BTEC in Pharmaceutical Science or equivalent recognised pharmacy technician qualification (post graduate level)
• Registered with GPhC or HCPC
• M Pharm (or equivalent) degree course and pre-registration
• Registered Pharmacist (MRPharmS)
• Clinical Diploma

Knowledge & Experience

Essential

• Microbiology/formulation/product design, and the chemical, pharmaceutical and clinical properties of ingredients
• Pharmaceutical Audit. MHRA/ Aseptic Dispensing
• Requirements for the provision of pharmacy production and / or preparation services
• Extensive practical and theoretical knowledge of Good Manufacturing Practice (Rules & Guidance for Pharmaceutical Manufacturers and Distributors) and Part 10 exemption
• Working practical and theoretical knowledge of Good Distribution Practice (Rules and Guidance for Pharmaceutical Distributors)
• Working practical and theoretical knowledge of Good Clinical Practice (Good Clinical Practice Guide)
• Working knowledge of isolator and/or laminar flow technology
• Application of health and safety and COSHH in pharmaceutical setting
• Requirements for training of all grades of technical and professional staff in the production setting

Desirable

• Experience in the preparation /Manufacture of non- sterile / sterile medicinal products under section 10 exemption / 'specials license'
• Clinical Pharmacy experience
• Working knowledge of sterilisers for pharmaceutical application/ WFI systems
• Validation/documentation/QA/drug administration equipment & methods/aseptic technique, contamination control and environmental monitoring

Skills & Abilities

Essential

• Excellent interpersonal and communication skills
• Organisation and planning skills
• Leadership and management skills
• Negotiation, persuasion and problem-solving skills
• Project management skills and knowledge
• Research and audit skills
• Broad IT skills
• Service improvement/change management skills
• Well-developed report writing and analytical and presentation skills
• Effective staff management skills
• Evidence of relevant continuous professional development
• Ability to lead meetings
• Counselling / mentoring
• Interviewing / appraisal
• Competency in using pharmacy computer systems
• Ability to manage change and meet deadlines
• Excellent communication skills

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).