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.

Main duties of the job

To provide expert technical product development input into the Pharmaceutical Lifecycle Management Team across the licensed manufacturing units in the trust.

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

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.

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.

About us

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.

Job description

Job responsibilities

Refer to Job Description for full details of the role
New Product Development

To provide expert technical product development input into the Pharmaceutical Lifecycle Management Team across the licensed manufacturing units in the trust.

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.

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.

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.

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.

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.

To co-ordinate the investigation into current manufacturing and product development methods with a view to optimising efficiency and improving safety and quality.

To critically review and assess all existing products prepared on a regular basis with a view for reformulation or expansion and upscale into optimal batch sizes under the MS and MIA(IMP) license from fully unlicensed activities.

To lead on feasibility studies for all new formulation, methodology, pilot batches and scale up and report these back to senior management at product development meetings.

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.

To liaise with the QC team to ensure availability of equipment and laboratory resources for development activities.

To identify key areas of technical services development strategy in line with Trust and National priorities and objectives, clinical need and risk management.

To deliver the key targets for the development agenda as agreed between the post holder, Production Manager and associate Chief To provide regular updates and reports on progress against agreed timescales.

To supervise and train all grades of staff in all aspects of formulation development and help to participate in the induction training of such staff.

To participate in the reviewing and updating of GMP control documentation such as worksheets and procedures relevant to new product introduction and updates to existing products.

To collaborate on projects where appropriate with other Pharmacy Production, QC, QA or external manufacturing or research units.

To co-ordinate individual project teams both within and external to the trust.

Person Specification

Qualifications

Essential

• Bachelors degree or equivalent experience in a technical in pharmaceutical sciences, chemistry or similar scientific subject

Desirable

• Post graduate qualification in suitable subject.
• Member of appropriate professional body and eligible to be a QP(IMP)/QP

Experience

Essential

• Appropriate post registration experience in a senior role and full time work in a licensed pharmaceutical production or aseptic unit with a wide portfolio of products
• Previous assessable experience of project management within a technical services environment
• Previous assessable experience of developing and expanding Technical Services to meet specific patient needs and reducing patient risk
• Previous experience working in a multi-disciplinary team within a GMP environment

Desirable

• Experience of: Terminal Sterilisation processes Non Sterile Product Manufacture (all dosage forms including tablet and capsule manufacture)

Knowledge

Essential

• Demonstrated evidence of being able to develop and deliver a Technical Services strategic development plan
• Demonstrated evidence of leading and managing formulation and new product development
• Demonstrated practical knowledge of GMP, pharmaceutical production, QA and all current regulations to enable operation at the highest level of practice.
• Demonstrated ability to undertake the formulation of patient specific medicines to meet their clinical needs
• Demonstrated knowledge of the validation requirements for pharmaceutical facilities, equipment and products.
• Demonstrated ability to solve difficult and ambiguous problems by advanced reasoning and sound technical judgment

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.

Employer details

Employer name

Guy's and St Thomas' NHS Foundation Trust

Address

Guy's Hospital

Great Maze Pond

London

SE1 9RT

Any attachments will be accessible after you click to apply.

196-LIS7575