Job summary
An exciting opportunity has arisen for a highly motivated Senior GMP Scientist to join the Newcastle Advanced Therapies Team within the Pharmacy Directorate to join the Quality Control laboratory dedicated to supporting the testing of cell and tissue-based medicines and therapeutic tissues and cells manufactured at Newcastle Advanced Therapies.
The post holder will use their scientific and operational skills to lead and organise a small laboratory performing analysis across a spectrum of development stages, from technology transfer and method optimisation to validation and final product testing. The postholder will be responsible for compliance of the laboratory and its activities with the relevant regulatory bodies (MHRA and HTA) and will be integral to facilitating the development and delivery of novel therapies from research to clinical practice.
Due to the niche subject area, it is anticipated many applicants may not have directly relevant experience in the specific analytical methods therefore onsite training will be provided. Applicants will be expected to understand and have experience of analytical testing in GMP environments, including the processes which must be followed in the event of unexpected results. Knowledge of cell and tissue-based QC analysis will be advantageous.
- Interview Date Thursday, 11 July 2024
- 37 Hours 30 Minutes/Week
Main duties of the job
Lead the QC laboratory by providing technical and scientific expertise to:
Translate and develop QC assays from pre-GMP to GMP compliant assays.
Plan and execute validation/ qualification activities for tests and equipment.
Perform troubleshooting and out of specification investigations where required.
Ensure service continuity by devising and executing training plans for other staff.
Contribute to wider service delivery by:
Working closely with the Production and QA leads to ensure the day to day running of the unit.
Facilitate project delivery by leading on the QC aspects of new projects including gap analysis and tech transfer processes.
Assisting the senior management team in delivery of departmental operational objectives.
About us
Newcastle Hospitals NHS Foundation Trust is one of the busiest, largest and most successful teaching NHS foundation trusts in the country, with around 16,000 staff and an annual income of £1 billion.
We have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.
We're also proud to be the second largest provider of specialised services in the country. This means we support people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders.
Our staff oversee around 2 million patients 'contacts' each year, delivering high standards of healthcare.
Please see attached information on what Staff Benefits we have to offer at our Trust.
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, gender, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups.
Job description
Job responsibilities
- The post holder will lead the day-to-day operations and future development of a small QC laboratory including workload management, organisational planning, method development and capability and capacity planning.
- The post holder will support the production manager and QA manager in the day to day running of the wider GMP Manufacturing Facility and in the delivery of project work.
- The QC laboratory is part of our GMP Manufacturing Facility, and wider activity supporting advanced therapies within Pharmacy.
- The role is predominantly based at the Centre for Life but there will be a requirement to work some shifts (or parts of shifts) at the RVI to meet the needs of the service.
- The post holder will be responsible for Quality Control Testing performed within Newcastle Advanced Therapies and ensuring advanced therapy products are in line with QC requirements for relevant regulatory bodies.
- The post holder will be responsible for the development, implementation, and validation of quality control assays.
- The post holder is responsible for the provision of an effective service of a specialised section within Pharmacy, to internal colleagues, external clients, and other users of the service. This will involve using highly developed knowledge and organisational skills and the post holder will be the lead specialist in that field.
- To provide specialised scientific knowledge and to work as a member of the team to assess, plan and contribute to the provision of a specialised service.
- To operate, maintain and monitor the quality control laboratory and ensure testing, documentation and sample storage is performed in compliance with the principles of Good Manufacturing Practice (GMP).
- To develop, implement and validate assays.
- To participate in the development of internal policy and procedures and ensure work is performed in accordance with prescribed protocol.
- To ensure all quality tests are performed, results validated, and judgement used in determining further tests that may be required.
- To interpret laboratory results and apply these to ensure that stored and issued tissues meets prescribed standards.
- To ensure the maintenance of cleanroom equipment is performed, and prompt and appropriate action is taken to ensure continued running of the service.
- To liaise with service users, product experts and academics to ensure suitable and effective assays are developed and performed.
- To liaise with Quality Assurance, Production and service users and other departments both within and outside of the Trust to ensure workload is in accordance with capacity and advanced therapy products are processed, released, and delivered to the relevant location when required.
- To participate in the use and maintenance of the Quality Assurance System and investigate situations and instigate corrective and preventative action.
- To work in compliance with local health and safety rules to ensure a safe working environment. To adhere to department and Trust Health and Safety policies (including COSHH, Risk assessments and Standard Operating Procedures) and to report any non-compliances to the Department Health and Safety Officer.
- After suitable training and competency assessment the post holder will be required to participate in the on-call rota (to respond to emergency alarms and issues) as required to meet the needs of the department.
- The post holder will be required to work flexibly with the occasional need for a shift outside of usual working hours to accommodate a laboratory process.
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.
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 months pay.
You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy.
Job description
Job responsibilities
- The post holder will lead the day-to-day operations and future development of a small QC laboratory including workload management, organisational planning, method development and capability and capacity planning.
- The post holder will support the production manager and QA manager in the day to day running of the wider GMP Manufacturing Facility and in the delivery of project work.
- The QC laboratory is part of our GMP Manufacturing Facility, and wider activity supporting advanced therapies within Pharmacy.
- The role is predominantly based at the Centre for Life but there will be a requirement to work some shifts (or parts of shifts) at the RVI to meet the needs of the service.
- The post holder will be responsible for Quality Control Testing performed within Newcastle Advanced Therapies and ensuring advanced therapy products are in line with QC requirements for relevant regulatory bodies.
- The post holder will be responsible for the development, implementation, and validation of quality control assays.
- The post holder is responsible for the provision of an effective service of a specialised section within Pharmacy, to internal colleagues, external clients, and other users of the service. This will involve using highly developed knowledge and organisational skills and the post holder will be the lead specialist in that field.
- To provide specialised scientific knowledge and to work as a member of the team to assess, plan and contribute to the provision of a specialised service.
- To operate, maintain and monitor the quality control laboratory and ensure testing, documentation and sample storage is performed in compliance with the principles of Good Manufacturing Practice (GMP).
- To develop, implement and validate assays.
- To participate in the development of internal policy and procedures and ensure work is performed in accordance with prescribed protocol.
- To ensure all quality tests are performed, results validated, and judgement used in determining further tests that may be required.
- To interpret laboratory results and apply these to ensure that stored and issued tissues meets prescribed standards.
- To ensure the maintenance of cleanroom equipment is performed, and prompt and appropriate action is taken to ensure continued running of the service.
- To liaise with service users, product experts and academics to ensure suitable and effective assays are developed and performed.
- To liaise with Quality Assurance, Production and service users and other departments both within and outside of the Trust to ensure workload is in accordance with capacity and advanced therapy products are processed, released, and delivered to the relevant location when required.
- To participate in the use and maintenance of the Quality Assurance System and investigate situations and instigate corrective and preventative action.
- To work in compliance with local health and safety rules to ensure a safe working environment. To adhere to department and Trust Health and Safety policies (including COSHH, Risk assessments and Standard Operating Procedures) and to report any non-compliances to the Department Health and Safety Officer.
- After suitable training and competency assessment the post holder will be required to participate in the on-call rota (to respond to emergency alarms and issues) as required to meet the needs of the department.
- The post holder will be required to work flexibly with the occasional need for a shift outside of usual working hours to accommodate a laboratory process.
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.
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 months pay.
You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy.
Person Specification
Qualifications & Education
Essential
- BSc. in Biomedical Science, Pharmaceutical Science, or an equivalent qualification
- Appropriate professional registration or eligible for registration with a relevant professional body
- MSc or equivalent level of knowledge and experience
Knowledge & Experience
Essential
- Demonstrable experience in laboratory assay development and validation
- Extensive experience and in-depth knowledge of quality control requirements within a GMP laboratory and/or clinical department (e.g., sterility, potency, purity etc).
Desirable
- Previous experience in flow cytometry and or microscopy
- Laboratory management experience
- An understanding of the regulatory requirements as applied to advanced therapies
- Laboratory experience in a GMP facility involving cells, genes and/or tissues
- Experience of preparation of sterile products using aseptic techniques would be an advantage
- Significant laboratory experience in a research environment
- Previous experience in the production of advanced therapy products
Skills & Abilities
Desirable
- Keyboard and I.T related skills
Person Specification
Qualifications & Education
Essential
- BSc. in Biomedical Science, Pharmaceutical Science, or an equivalent qualification
- Appropriate professional registration or eligible for registration with a relevant professional body
- MSc or equivalent level of knowledge and experience
Knowledge & Experience
Essential
- Demonstrable experience in laboratory assay development and validation
- Extensive experience and in-depth knowledge of quality control requirements within a GMP laboratory and/or clinical department (e.g., sterility, potency, purity etc).
Desirable
- Previous experience in flow cytometry and or microscopy
- Laboratory management experience
- An understanding of the regulatory requirements as applied to advanced therapies
- Laboratory experience in a GMP facility involving cells, genes and/or tissues
- Experience of preparation of sterile products using aseptic techniques would be an advantage
- Significant laboratory experience in a research environment
- Previous experience in the production of advanced therapy products
Skills & Abilities
Desirable
- Keyboard and I.T related 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.
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).
