Senior Process Chemist

The senior process development chemist role will provide production support to the API (active pharmaceutical ingredient) manufacturing facility. The role will include technical transfer and development of new processes, as well as monitoring/improvement of existing processes. The role will also include generation of batch, validation and procedural documentation relating to API production as well as completion of deviation reports and implementation of corrective/preventative actions.

Key Roles/Responsibilities:

To maintain the highest level of safety in all work areas, with particular focus on lab and production continuous improvement of practices and procedures.

To carry out technical transfer, development and optimisation of processes in the laboratory, consistent with production/customer requirements.

To perform scale-up and transfer of processes from the lab to the API production facility, including on-going production support.

To provide general production support for existing manufacturing processes including lab use-tests and technical recommendations as required.

To examine existing processes, to enable process optimisation and product life cycle maintenance, as well as improve quality, reliability, safety and cost.

To participate in multi-disciplinary work teams concerned with new and existing products. To liaise as appropriate with senior members of the chemical technology team, as well as other departments including API production, QC, QA and ESH.

To generate technical documentation to support API manufacture, including development reports, bath records, deviation reports (including CAPA), change controls and validation documentation.

To maintains their position as SME for Morpeth process and lead troubleshooting activities where production issues have occurred.

To develop strong links with external customers’ key technical contacts, to build strong customer relationships and improve the likelihood of repeating business.

To maintain a high standard of awareness of recent advances in synthesis development and scale up activities.

To development and provide training for junior staff, to enable them to take on key project roles or responsibilities in the future.

Competencies:

Should have experience of API process development and GMP manufacture in the pharmaceutical industry.

Should have good knowledge of the pharmaceutical product life-cycle, including the requirements for products in late stage clinical trials and those in commercial supply.

Should have good process development skills and the ability to plan experimental development work with little support. They should also have a good knowledge of API manufacturing at industrial scale and factors affecting scale-up.

Should have experience in generating GMP documentation including manufacturing procedures, change control CAPA and process deviation reports.

They should have good communication skills, with the ability to write and present technical data with ease, including process validation documentation.

They should be adaptable, with the ability to work on multiple projects and change focus depending on business demand.