Senior Aseptic services Pharmacist - ATMPs, Clinical Trials and CIVAS

NHS; London; On-site; GBP 61,000 - 69,000; Full time

Job description

Senior Aseptic services Pharmacist - ATMPs, Clinical Trials and CIVAS

Guy's and St Thomas' NHS Foundation Trust

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.

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

• 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 understanding of the requirements for an effective contamination control strategy for 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

• 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.
• Experience of being audited by external bodies e.g. MHRA GMP inspections, Regional Quality EL audits.

Qualifications

• 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.

Guy's and St Thomas' NHS Foundation Trust

£61,927 to £68,676 a year inclusive of HCA