Job summary
Calderdale & Huddersfield NHS Foundation Trust is a dynamic and successful organisation with a strong organisational and personal development focus. With over 5,500 employees and a turnover of £310 million, the Trust provides a comprehensive range of secondary care services to the people of Calderdale and Huddersfield and has an exceptional reputation for service delivery.
The Foundation Trust aims to design and implement services, policies and measures that meet the diverse needs of our service, population and workforce, ensuring that none are placed at a disadvantage over others.
Huddersfield Pharmacy Specials (HPS) is a NHS hosted Specials manufacturing unit.Our mission is to provide high quality, affordable specials throughout the UK to both Primary and Secondary Care. HPS manufactures a wide range of products including dermatological, oral and topical liquids, infusion fluids and ampoules. We also provide a bespoke medicines packaging and labeling service.
The facility has a MHRA Manufacturer (MIA) and "Specials" (MS) Licenses, a Wholesale Distribution Authorization (WDA(H)) and a Manufacturer License for Investigational Medicinal Products (Clinical Trials) (MIA(IMP)).
HPS is a semi-autonomous division reporting to the CHFT Board through its own Management Board.
Main duties of the job
The post holder will be required to work under the direction of The Head of R&D and Regulatory Affairs and a Senior Development Scientist and will follow work programs, carry out experimental work, generate and complete development protocols and reports in accordance with the principles of current Good Manufacturing Practice (cGMP) and Good Control Laboratory Practice (GCLP). The post holder will work closely with Formulation Scientists and be responsible for the development of analytical methods, stability testing of new products and validation of methods for use in quality Control (QC).
Major activities will include analytical and formulation development and subsequent new product introduction activities in Huddersfield Pharmacy Specials. HPS is a manufacturer of Unlicensed Medicines (Specials) and supplies products to the whole of the UK.
About us
We employ more than 6,500 staffwho deliver compassionate care from our two main hospitals,Calderdale Royal Hospital and Huddersfield Royal Infirmary as well as in community sites, healthcentres and in patients' homes. We also are incredibly proud to have almost 150 volunteers here at CHFT.
We provide a range of services including urgent and emergency care; medical; surgical; maternity; gynaecology; critical care; children's and young people's services; end of life care and outpatient and diagnostic imaging services.
We provide community health services, including sexual health services in Calderdale from Calderdale Royal and local health centres. These include Todmorden Health Centre and Broad Street Plaza.
We continue to modernise and invest in our health services to build on our strong reputation.Foundation trusts are public leaders in improving quality in health services. They are part of the NHS- yet decisions about what they do and how they do it are driven by independent boards. Boardslisten to their Council of Governors and respond to the needs of their members - patients, staff andthe local community.
Foundation trusts provide what the health service wants, yet are also free to invest quickly in thechanges to the local community needs, in striving to be the best, and in putting their patients first.
Job description
Job responsibilities
Main Tasks
New Product Development
- Develop appropriate, robust methods for the analysis of new pharmaceutical formulations.
- Analyse prototype and stability samples as required and report results in a timely manner.
- Ensure all development activities are in line with departmental procedures.
- Liaise with other members of the development and Quality Control to ensure availability of equipment and laboratory resources for development activities.
- Perform analysis of validation batches.
- Liaise with the Formulation Pharmacist to generate New Product specifications.
Analytical Duties
- Write and execute validation protocols and reports for transfer to QC, in compliance with ICH expectations.
- Liaise with QC staff to ensure effective technology transfer of new products into routine analysis.
- Assists with the completion of corrective and preventive actions arising from Quality Incidents within agreed time frames.
- Complies with Health and Safety and COSHH regulations within the section.
- Identify future equipment needs for the continuing development of HPS capabilities in analytical development.
- Ensures all testing undertaken is performed in accordance with laboratory specifications and standard operating procedures.
- Use Quality by Design principles in the design of new methods.
- Participate in the Personal Development Review Programme.
Other Duties
- Attend all mandatory training.
- Participate annually identifying, developing and agreeing your own development plan with your Line Manager using the Trust Appraisal.
- Comply with all Trust policies, procedures and protocols.
- Carry out duties with due regard to the Trusts Equal Opportunity Policy.
- Seek advice and support from Line Manager whenever necessary.
- Maintain professional conduct including appearance at all times.
- Handles and moves goods and equipment (maximum weight 25kg), transferring them between cages, trolleys, cupboards, work areas and shelving that are at different levels.
- Healthcare workers have an overriding duty of care to patients and are expected to comply fully with best practice standards. You have a responsibility to comply with Trust policies for personal and patient safety and for prevention of healthcare-associated infection (HCAI); this includes a requirement for rigorous and consistent compliance with Trust policies for hand hygiene including the naked below the elbow approach, use of personal protective equipment and safe disposal of sharps. Knowledge, skills and behaviour in the workplace should reflect this; at annual appraisal you will be asked about the application of practical measures known to be effective in reducing HCAI. The Trust has the responsibility of ensuring that adequate resources are available for you to discharge your responsibilities.
- Complies with Trust and departmental policies relating to security and patient confidentiality ensuring that procedures are carried out in accordance with safe systems of work and current legislation.
Job description
Job responsibilities
Main Tasks
New Product Development
- Develop appropriate, robust methods for the analysis of new pharmaceutical formulations.
- Analyse prototype and stability samples as required and report results in a timely manner.
- Ensure all development activities are in line with departmental procedures.
- Liaise with other members of the development and Quality Control to ensure availability of equipment and laboratory resources for development activities.
- Perform analysis of validation batches.
- Liaise with the Formulation Pharmacist to generate New Product specifications.
Analytical Duties
- Write and execute validation protocols and reports for transfer to QC, in compliance with ICH expectations.
- Liaise with QC staff to ensure effective technology transfer of new products into routine analysis.
- Assists with the completion of corrective and preventive actions arising from Quality Incidents within agreed time frames.
- Complies with Health and Safety and COSHH regulations within the section.
- Identify future equipment needs for the continuing development of HPS capabilities in analytical development.
- Ensures all testing undertaken is performed in accordance with laboratory specifications and standard operating procedures.
- Use Quality by Design principles in the design of new methods.
- Participate in the Personal Development Review Programme.
Other Duties
- Attend all mandatory training.
- Participate annually identifying, developing and agreeing your own development plan with your Line Manager using the Trust Appraisal.
- Comply with all Trust policies, procedures and protocols.
- Carry out duties with due regard to the Trusts Equal Opportunity Policy.
- Seek advice and support from Line Manager whenever necessary.
- Maintain professional conduct including appearance at all times.
- Handles and moves goods and equipment (maximum weight 25kg), transferring them between cages, trolleys, cupboards, work areas and shelving that are at different levels.
- Healthcare workers have an overriding duty of care to patients and are expected to comply fully with best practice standards. You have a responsibility to comply with Trust policies for personal and patient safety and for prevention of healthcare-associated infection (HCAI); this includes a requirement for rigorous and consistent compliance with Trust policies for hand hygiene including the naked below the elbow approach, use of personal protective equipment and safe disposal of sharps. Knowledge, skills and behaviour in the workplace should reflect this; at annual appraisal you will be asked about the application of practical measures known to be effective in reducing HCAI. The Trust has the responsibility of ensuring that adequate resources are available for you to discharge your responsibilities.
- Complies with Trust and departmental policies relating to security and patient confidentiality ensuring that procedures are carried out in accordance with safe systems of work and current legislation.
Person Specification
QUALIFICATIONS / TRAINING
Essential
- Degree in Chemistry, Pharmaceutical Sciences or equivalent scientific qualification.
Desirable
- MSc in Chemistry or other appropriate scientific discipline
KNOWLEDGE, EXPERIENCE & EXPERTISE
Essential
- QC stability analysis of pharmaceutical formulations by HPLC in a commercial laboratory.
- Ability to prepare scientific documentation for regulatory submissions
Desirable
- Knowledge of Clinical Trials and Medical Devices and Raw Materials analysis
SPECIAL KNOWLEDGE EXPERTISE
Essential
- Development of Analytical Methods. HPLC. GC. Validation to ICH guidelines
- Significant experience in Analytical Method development.
TRAINING
Essential
- To complete in house training program covering the principles of Good Manufacturing Practice, operation of various QC instrumentation, COSHH etc.
- Health and Safety Training
- Lifting and Handling Training
GENERAL
Essential
- Must be eligible to work in the UK.
- Ability to work in various locations throughout the network of services provided by Calderdale and Huddersfield NHS Foundation Trust.
Person Specification
QUALIFICATIONS / TRAINING
Essential
- Degree in Chemistry, Pharmaceutical Sciences or equivalent scientific qualification.
Desirable
- MSc in Chemistry or other appropriate scientific discipline
KNOWLEDGE, EXPERIENCE & EXPERTISE
Essential
- QC stability analysis of pharmaceutical formulations by HPLC in a commercial laboratory.
- Ability to prepare scientific documentation for regulatory submissions
Desirable
- Knowledge of Clinical Trials and Medical Devices and Raw Materials analysis
SPECIAL KNOWLEDGE EXPERTISE
Essential
- Development of Analytical Methods. HPLC. GC. Validation to ICH guidelines
- Significant experience in Analytical Method development.
TRAINING
Essential
- To complete in house training program covering the principles of Good Manufacturing Practice, operation of various QC instrumentation, COSHH etc.
- Health and Safety Training
- Lifting and Handling Training
GENERAL
Essential
- Must be eligible to work in the UK.
- Ability to work in various locations throughout the network of services provided by Calderdale and Huddersfield NHS Foundation Trust.
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.
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).
Additional information
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.
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).
Employer details
Employer name
Calderdale and Huddersfield NHS Foundation Trust
Address
NHS Huddersfield Pharmacy Specials
Gate 2 Acre Mill, School Street West
Huddersfield
HD3 3ET
Employer's website
https://www.cht.nhs.uk (Opens in a new tab)
