Job summary
Senior Aseptic Services Pharmacist - ATMPs, Clinical Trials & CIVAS
Are you a skilled and motivated pharmacist looking to advance your career in aseptic services? We are seeking an enthusiasticSenior Aseptic Services Pharmacist to join our team at Guy's and St Thomas'. This role offers a unique opportunity to contribute to the aseptic preparation of Advanced Therapy Medicinal Products (ATMPs), clinical trials, and CIVAS while ensuring the highest standards of quality and regulatory compliance.
As a key member of our aseptic services team, you will bring experience as an authorised pharmacist with a strong understanding of operational, quality, and regulatory requirements within an aseptic preparation unit. Working closely with and deputizing for the Accountable Pharmacist, you will play a vital role in ensuring the correct preparation of both existing and novel products, as well as overseeing staff training and compliance.
This is an exciting time to join us, as we expand aseptic services across multiple sites. The successful candidate will have the opportunity to work flexibly across different locations, contributing their expertise to cutting-edge pharmaceutical developments. A solid grasp of contamination control, risk assessment, and regulatory frameworks will be key to excelling in this role.
If you're passionate about innovation in aseptic services and want to be part of a forward-thinking team, we'd love to hear from you!
Main duties of the job
- To be the deputy accountable pharmacist in the leadership and delivery of aseptic service for Guy's site aseptic preparation of advanced therapies, clinical trials and CIVAS. To work flexibly on either site in response to service review and changes.
- To be responsible for ensuring the requirements of the aseptic unit's quality management system are maintained as required by Quality Assurance of Aseptic Preparation Services (QAAPS) and other NHS guidance.
- To lead and be responsible for the set up and delivery of aseptic services to support new products and clinical trials for GSTT and commercial sponsored trials to ensure full manufacturing and clinical regulatory compliance.
About us
Guy's and St Thomas' is among the UK's busiest and most successful NHS Foundation Trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopedic, respiratory and cardiovascular services.
Guy's & St Thomas' Technical Services is a large licensed and section 10 manufacturing unit with a wide product portfolio, including terminally sterilised and non-sterile manufacturing, as well as a variety of extemporaneously prepared aseptic and non-sterile dosage forms.
Aseptic services are currently based on the Guy's and St Thomas' sites with new and upgraded facilities on the St Thomas' site and a recently recommissioned aseptic containment suite on the Guy's site.
Pharmacy Technical Services employs over 100 staff in multiple areas across the Guy's and St Thomas' sites.
Job description
Job responsibilities
Key areas of role performance - see job description for details:
Quality and Service management
Service evaluation and development
New products and clinical trials
Job description
Job responsibilities
Key areas of role performance - see job description for details:
Quality and Service management
Service evaluation and development
New products and clinical trials
Person Specification
Skills
Essential
- Demonstrated practical knowledge of GCP, GMP, QA as required to ensure compliance of aseptic preparation of medicines.
- Demonstrated ability to undertake risk and impact assessments, investigations, root cause analysis and developing action plans for out of specification results and process deviations within the context of an aseptic quality system
- Be able to demonstrate a practical understand of the requirements for an effective contamination control strategy for an aseptic preparation services and how this should be developed.
- Demonstrated knowledge of the validation requirements for pharmaceutical facilities, equipment and products.
- Demonstrated evidence of being able to manage change with production services
Experience
Essential
- Previous assessable experience of supervising operations and undertaking aseptic product release in an unlicensed aseptic unit with a comprehensive portfolio of aseptic products.
- Previous evaluated experience of managing the introduction, operation and audit of IMPs requiring aseptic preparation according to GMP and GCP
- Previous assessable experience of managing workload and capacity to ensure safe working levels
Desirable
- Experience of being audited by external bodies e.g. MHRA GMP inspections, Regional Quality EL audits
Qualifications
Essential
- Pharmacy degree or Masters degree in science based discipline
- Post-graduate qualification relevant to pharmaceutical manufacturing or portfolio that demonstrates the acquisition and use of an equivalent level of specialist pharmaceutical knowledge
Person Specification
Skills
Essential
- Demonstrated practical knowledge of GCP, GMP, QA as required to ensure compliance of aseptic preparation of medicines.
- Demonstrated ability to undertake risk and impact assessments, investigations, root cause analysis and developing action plans for out of specification results and process deviations within the context of an aseptic quality system
- Be able to demonstrate a practical understand of the requirements for an effective contamination control strategy for an aseptic preparation services and how this should be developed.
- Demonstrated knowledge of the validation requirements for pharmaceutical facilities, equipment and products.
- Demonstrated evidence of being able to manage change with production services
Experience
Essential
- Previous assessable experience of supervising operations and undertaking aseptic product release in an unlicensed aseptic unit with a comprehensive portfolio of aseptic products.
- Previous evaluated experience of managing the introduction, operation and audit of IMPs requiring aseptic preparation according to GMP and GCP
- Previous assessable experience of managing workload and capacity to ensure safe working levels
Desirable
- Experience of being audited by external bodies e.g. MHRA GMP inspections, Regional Quality EL audits
Qualifications
Essential
- Pharmacy degree or Masters degree in science based discipline
- Post-graduate qualification relevant to pharmaceutical manufacturing or portfolio that demonstrates the acquisition and use of an equivalent level of specialist pharmaceutical knowledge
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
