Product Lifecycle Specialist

1 month ago

London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time

We are recruiting a dynamic individual to lead key projects such as the development and upscale of new MS batch lines in sterile large and small volume injectables, oral solid dosage forms and aseptic fill.

To work collaboratively with the production team to optimise existing product lines providing specialist technical support with formulation development.

To lead on product introduction projects across the various manufacturing facilities and dosage forms within the trust. Including preparation of small scale bench top formulations ready for further upscale and development for clinical trials to be prepared under the MIA(IMP) licence.

To write and lead on the execution of validation protocols for new products, services and equipment.

To develop GSTFT as a proven centre of excellence in the technical development environment.

To integrate and work with clinical academic partners within KHP and other wider research networks to assist and provide specialist advise on the deliverance of key projects for clinical research objectives.

To develop new products in line with the trust and national clinical development objectives as part of the department and trusts overall service deliverance strategy and ensure financial realisations are delivered.
1. To provide expert technical product development input into the Pharmaceutical Lifecycle Management Team across the licensed manufacturing units in the trust.
2. To be responsible in leading and delivering the development and validation of new products being introduced for use within Technical Services in response to clinical need and risk management
3. To co-ordinate the critical assessment of current manufacturing formulations along with critical equipment and processed and analytical testing methods with a view to improving the quality and efficiency of the manufacturing process.
4. To develop new products in response to customer requests and lead on the successful technology transfer into routine production and oversee the manufacture of the first sales batch of each new product.

Guy’s & St Thomas NHS Foundation Trust Guy’s and St Thomas’ NHS Foundation Trust comprises five of the UK’s best known hospitals - Guy’s, St Thomas’, Evelina London Children’s Hospital, Royal Brompton and Harefield - as well as community services in Lambeth and Southwark, all with a long history of high quality care, clinical excellence, research and innovation.

We are among the UK’s busiest, most successful foundation trusts. We provide specialist care for patients including heart and lung, cancer and renal services as well as a full range of local hospital and community services for people in Lambeth and Southwark.

We have a long tradition of clinical and scientific achievement and - as part of King’s Health Partners - we are one of England’s eight academic health sciences centres, bringing together world-class clinical services, teaching and research. We have one of the National Institute for Health Research’s biomedical research centres, established with King’s College London in 2007, as well as dedicated clinical research facilities.

We have around 22,700 staff, making us one of the largest NHS Trusts in the country and one of the biggest employers locally. We aim to reflect the diversity of the communities we serve and continue to develop new and existing partnerships with local people, patients, neighbouring NHS organisations, local authorities and charitable bodies and GPs.

Refer to Job Description for full details of the role
New Product Development1. To provide expert technical product development input into the Pharmaceutical Lifecycle Management Team across the licensed manufacturing units in the trust.
2. To identify key areas of product development and develop and deliver on strategies in line with Trust and National priorities and objectives, clinical need and risk management.
3. To deliver the key targets for this development agenda as agreed between the post holder, Production Manager, Pharmaceutical Lifecycle Manager and Head of Quality. To provide regular updates and reports on progress against agreed timescales.
4. To be responsible in leading and delivering the development and validation of new products being introduced for use within Technical Services in response to clinical need and risk management.
5. To co-ordinate the critical assessment of current manufacturing formulations along with critical equipment and processed and analytical testing methods with a view to improving the quality and efficiency of the manufacturing process.
6. To liaise with the Quality Control department over quality control matters such as in-process controls, raw material and release testing, analytical method development, bench top testing and development work for new products or reformulation of existing products including advice and construction of stability protocols in accordance with ICH guidelines.
7. To co-ordinate the investigation into current

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