Formulation & Product Dev...
Salary not available. View on company website.
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne
- Full time
- Permanent
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The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne
- Full time
- Temporary
Apply on company site
Posted 1 week ago, 13 Aug
Formulation & Product Development Manager
Salary not available. View on company website.
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne
- Onsite working
- Full time
- Permanent
Posted today, 23 Aug
Job ref: 9b599b1eb68643ebb9e0ff19397c5ad8
Full Job Description
We are looking for an enthusiastic and motivated individual to join our dedicated Pharmacy Production Team in the role of Formulation and Product Development Manager. Working between our production and quality control departments, you will lead development and formulation of new and existing pharmaceutical products. You will ensure concepts of Quality by Design are applied throughout product and process development and improvement cycles. You will work with our clients, customers and service users to introduce new pharmaceutical products and drive project delivery requirements to meet tight timelines., With excellent communication and organisational skills, you will lead implementation, development and formulation of new and existing pharmaceutical products to meet the needs of Trust patients, our customers and commercial partners.
You will ensure concepts of Quality by Design (QbD) are applied and that Quality Risk Management and Pharmaceutical Quality Systems are considered and applied through translation to final product manufacture or preparation. You will develop New Product Introduction Strategy, coordinating quality and production departments to enable timely introduction.
Identifying Target Product Profile (TPP), Target Product Quality Profile (TPQP),Critical Quality Attributes for new products in development, you will design and develop product and manufacturing processes, co-ordinate assessment and management of risks and control strategy.
Using GANTT charts/other tools you will project manage, reporting on progress against target, identify milestones and areas that may introduce delay and strategies to overcome., 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
Important note on completion of reference section of Application Form
All references from current and previous employers will be sought and must cover a minimum of 3 years employment. Therefore, when completing the reference section of your application form, please give the address, telephone number and work email address of each of your current/previous line managers that cover 3 years employment. Failure to complete this section may result in your application not being processed.
Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate. The method of payment is a salary deduction from your first month's pay.
Candidates who are shortlisted for interview will be contacted by e-mail. You should check your SPAM folders as well as your inbox. If you have not been contacted within 4 weeks of the closing date you should assume your application has been unsuccessful.
You will have Masters level qualification or equivalent qualification or equivalent experience in a relevant discipline, with a professional requirement for CPD and continuing education as required. with experience of managing organisational change in response to advancing regulatory standards.
Newcastle Hospitals NHS Foundation Trust is one of the busiest and largest NHS foundation trusts in the country, with around 15,000 staff and an annual budget of £1.6 billion.
We have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.
We're in the top five providers of specialised health services in the country, supporting people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders.
Our staff oversee around 6,500 patient contacts each day, delivering high standards of healthcare.
We are committed to promoting equality and diversity and recognise the benefit in providing an inclusive environment. We value and respect the diversity of our employees and aim to recruit a workforce which reflects the communities we serve, and is equipped to deliver the best service to our patients. We welcome all applications irrespective of people's race, disability, sex, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups.
Newcastle Hospitals are proud to be one of the exemplar organisations across the NHS on sustainability, with a long history of delivering Sustainable Healthcare in Newcastle (Shine) and the first healthcare organisation in the world to declare a climate emergency. Our strategy includes commitments to being Net Zero by 2030, for our direct carbon footprint, and Net Zero by 2040 for our footprint plus. Delivering these ambitions will not be possible without the help, support and action of every single member of our team.
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
Our staff oversee over 6,500 patient contacts every day, delivering high standards of healthcare from the following sites:
+ Freeman Hospital
+ Royal Victoria Infirmary (RVI)
+ Health Innovation Neighbourhood (on the former Newcastle General Hospital and Centre for Ageing and Vitality site)
+ Newcastle Dental Hospital
+ Newcastle Fertility Centre
+ Northern Centre for Cancer Care, North Cumbria
+ Northern Genetics Service
+ Cramlington Manor Walks
These include a range of flagship services which deliver cutting-edge care (supported by state-of-the-art diagnostic services in both radiology and pathology) and are a catalyst for innovation to support pioneering clinical practice in the NHS.
We also have offices at Regent Point in Gosforth and community sites.
Please see attached information on what Staff Benefits we have to offer at our Trust under 'Documents to download' or 'Supporting documents'.
For further information on The Newcastle upon Tyne Hospitals NHS Foundation Trust please visit: Careers | Newcastle Hospitals | NHS | Newcastle Hospitals and Newcastle Hospitals NHS Foundation Trust
You will ensure concepts of Quality by Design (QbD) are applied and that Quality Risk Management and Pharmaceutical Quality Systems are considered and applied through translation to final product manufacture or preparation. You will develop New Product Introduction Strategy, coordinating quality and production departments to enable timely introduction.
Identifying Target Product Profile (TPP), Target Product Quality Profile (TPQP),Critical Quality Attributes for new products in development, you will design and develop product and manufacturing processes, co-ordinate assessment and management of risks and control strategy.
Using GANTT charts/other tools you will project manage, reporting on progress against target, identify milestones and areas that may introduce delay and strategies to overcome., 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
Important note on completion of reference section of Application Form
All references from current and previous employers will be sought and must cover a minimum of 3 years employment. Therefore, when completing the reference section of your application form, please give the address, telephone number and work email address of each of your current/previous line managers that cover 3 years employment. Failure to complete this section may result in your application not being processed.
Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate. The method of payment is a salary deduction from your first month's pay.
Candidates who are shortlisted for interview will be contacted by e-mail. You should check your SPAM folders as well as your inbox. If you have not been contacted within 4 weeks of the closing date you should assume your application has been unsuccessful.
You will have Masters level qualification or equivalent qualification or equivalent experience in a relevant discipline, with a professional requirement for CPD and continuing education as required. with experience of managing organisational change in response to advancing regulatory standards.
Newcastle Hospitals NHS Foundation Trust is one of the busiest and largest NHS foundation trusts in the country, with around 15,000 staff and an annual budget of £1.6 billion.
We have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.
We're in the top five providers of specialised health services in the country, supporting people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders.
Our staff oversee around 6,500 patient contacts each day, delivering high standards of healthcare.
We are committed to promoting equality and diversity and recognise the benefit in providing an inclusive environment. We value and respect the diversity of our employees and aim to recruit a workforce which reflects the communities we serve, and is equipped to deliver the best service to our patients. We welcome all applications irrespective of people's race, disability, sex, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups.
Newcastle Hospitals are proud to be one of the exemplar organisations across the NHS on sustainability, with a long history of delivering Sustainable Healthcare in Newcastle (Shine) and the first healthcare organisation in the world to declare a climate emergency. Our strategy includes commitments to being Net Zero by 2030, for our direct carbon footprint, and Net Zero by 2040 for our footprint plus. Delivering these ambitions will not be possible without the help, support and action of every single member of our team.
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
Our staff oversee over 6,500 patient contacts every day, delivering high standards of healthcare from the following sites:
+ Freeman Hospital
+ Royal Victoria Infirmary (RVI)
+ Health Innovation Neighbourhood (on the former Newcastle General Hospital and Centre for Ageing and Vitality site)
+ Newcastle Dental Hospital
+ Newcastle Fertility Centre
+ Northern Centre for Cancer Care, North Cumbria
+ Northern Genetics Service
+ Cramlington Manor Walks
These include a range of flagship services which deliver cutting-edge care (supported by state-of-the-art diagnostic services in both radiology and pathology) and are a catalyst for innovation to support pioneering clinical practice in the NHS.
We also have offices at Regent Point in Gosforth and community sites.
Please see attached information on what Staff Benefits we have to offer at our Trust under 'Documents to download' or 'Supporting documents'.
For further information on The Newcastle upon Tyne Hospitals NHS Foundation Trust please visit: Careers | Newcastle Hospitals | NHS | Newcastle Hospitals and Newcastle Hospitals NHS Foundation Trust
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