Job summary
An excellent opportunity has presented itself at GOSH, Zayed Centre for Research into Rare Disease (ZCR) in children for a Senior Quality Control Scientist in our Cell and Gene Therapy Service. We are proud of being part of a well renowned national centre of excellence in the provision of specialist children's health care, currently delivering the widest range of specialist care of any children's hospital in the UK.
The Cell and Gene Therapy Service manufactures life-saving therapies for paediatric patients under both our MHRA and HTA licences. We are expecting to soon manufacture within our new state of the art, purpose-built facility (ZCR), comprising of seven cGMP compliant laboratories and support services. Our manufacturing facilities are licensed by the MHRA to allow us to function within the terms of our MIA(IMP) and MS licences.
The Senior Quality Control Scientist plays a crucial role in ensuring the compliance of QC activities with internal SOPs, GMP principles, and regulatory requirements. They will oversee day-to-day Environmental Monitoring (EM) operations, provide microbiological expertise, conduct investigations, and implement corrective actions. The role involves maintaining QC documentation, participating in technology transfer and validation activities, and collaborating with internal and external stakeholders.
Please note previous applicants need not apply
Main duties of the job
The post holder will also contribute to the continuous improvement of QC processes, maintain compliance with licensing requirements, and support the safe and efficient provision of QC services within the service.
We are therefore seeking an experienced and qualified individual with a strong background in microbiology or a related scientific discipline. The ideal candidate will have hands-on experience with cleanroom environmental monitoring programs, aseptic techniques, and analytical QC testing of Advanced Therapy Medicinal Products (ATMPs). Knowledge of GMP regulations and experience in qualification/validation of QC test methods are essential. Strong communication, attention to detail, organisational skills, and the ability to work both independently and collaboratively are key attributes for this role. The candidate should demonstrate problem-solving abilities, a positive attitude, and a commitment to continuous professional development.
This is a fantastic opportunity to join our friendly and welcoming Quality team with its great diversity of skills and experience, we look forward to receiving your application.
For further information, please contact:
Shok Ping Lim (shokping.lim@gosh.nhs.uk)
Interview to take place week commencing 17/07/2023
About us
GOSH is committed to recruiting the best person for the job, based solely on their ability and individual merit as measured against the criteria for the role; through a process that is fair, open, consistent and free from bias and discrimination.We are committed to being a diverse and inclusive employer and foster a culture where all staff are valued, respected and acknowledged. All applicants will receive consideration for employment without regard to race, colour, national origin, religion, sexual orientation, gender, gender identity, age, disability status or length of time spent unemployed.We particularly welcome applications from BAME communities, people with disabilities and/or long-term health conditions and LGBT+ community members.We have policies and procedures in place to ensure that all applicants and employees are treated fairly and consistently. We are proud to be accredited as a Disability Confident Employer, a member of Business Disability Forum and a Stonewall Diversity Champion.We have active and Executive supported BAME, LGBT+ and Allies, Disability and Long-Term Health Conditions and Women's staff networks. Staff networks are employee-led groups formed around interests, issues and a common bond or background. Staff network members create a positive and inclusive work environment at Great Ormond Street Hospital by actively contributing to the Trust's mission, values and efforts specific to inclusion. All of our staff networks are open to any employee.
Job description
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience and knowledge required. For both documents please view the attachment/s below.
Job description
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience and knowledge required. For both documents please view the attachment/s below.
Person Specification
GOSH Culture and Values
Essential
- GOSH Always Values
- Knowledge and understanding of diverse backgrounds and perspectives
- Understanding of Diversity and Inclusion challenges in the workplace
- Demonstrable contribution to advancing Equality, Diversity and Inclusion in the Workplace
Academic/Professional qualification/Training
Essential
- BSc or equivalent in Microbiology, Biology or other related scientific discipline
Desirable
- MSc or equivalent in Microbiology, Biology or other related scientific discipline
Experience/Knowledge
Essential
- Experience of cleanroom environmental monitoring programmes and aseptic technique
- Experience of IPC and analytical QC testing of ATMP products
- Knowledge of GMP regulations, EP and USP testing, specifically in the context of sterile product manufacture
- Experience in qualification and validation of QC test methods
- Experience in investigation of OOS results and implementation of CAPAs
- IT competent (Word, Excel and Power Point)
Desirable
- Knowledge of Cell and Gene Therapy
- Experience of working in a licensed facility holding an MIA(IMP)
- Experience in QMS Management
- Experience of using Q-Pulse
Skills/Abilities
Essential
- Ability to communicate information effectively both orally and in writing
- Good attention to detail and accuracy
- Strong organisational skills and demonstrated ability to prioritise and meet deadlines
- Ability to work independently and as part of a team
- Good problem-solving skills
- Ability to self-motivate and a positive attitude
- Show initiative and provide support to other staff members
Person Specification
GOSH Culture and Values
Essential
- GOSH Always Values
- Knowledge and understanding of diverse backgrounds and perspectives
- Understanding of Diversity and Inclusion challenges in the workplace
- Demonstrable contribution to advancing Equality, Diversity and Inclusion in the Workplace
Academic/Professional qualification/Training
Essential
- BSc or equivalent in Microbiology, Biology or other related scientific discipline
Desirable
- MSc or equivalent in Microbiology, Biology or other related scientific discipline
Experience/Knowledge
Essential
- Experience of cleanroom environmental monitoring programmes and aseptic technique
- Experience of IPC and analytical QC testing of ATMP products
- Knowledge of GMP regulations, EP and USP testing, specifically in the context of sterile product manufacture
- Experience in qualification and validation of QC test methods
- Experience in investigation of OOS results and implementation of CAPAs
- IT competent (Word, Excel and Power Point)
Desirable
- Knowledge of Cell and Gene Therapy
- Experience of working in a licensed facility holding an MIA(IMP)
- Experience in QMS Management
- Experience of using Q-Pulse
Skills/Abilities
Essential
- Ability to communicate information effectively both orally and in writing
- Good attention to detail and accuracy
- Strong organisational skills and demonstrated ability to prioritise and meet deadlines
- Ability to work independently and as part of a team
- Good problem-solving skills
- Ability to self-motivate and a positive attitude
- Show initiative and provide support to other staff members
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
Great Ormond Street Hospital for Children NHS Foundation Trust
Address
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
Employer's website
https://www.gosh.nhs.uk/ (Opens in a new tab)
