Senior Engineer - Synthetic Drug Substance Engineering

JOB TITLE: Senior Engineer - Synthetic Drug Substance Engineering

JOB DESCRIPTION:

The successful candidate will apply chemical engineering and chemistry knowledge to support commercial production of API processes. In this role, the candidate will be responsible for a scope of work that will include:

TASKS:

- Technical oversight for API production for small molecule products manufacture.
- Detailed analysis and interpretation of production data and information as part of Continued Process Verification, including actions to ensure process performance
- Root cause investigations for non-conformance and out of spec incidents including process impact and corrective action.
- Evaluation of the impact of changes to process inputs, equipment or procedures on process performance and API quality attributes
- Design, development and implementation of process improvements to enhance quality or improve efficiency of processes
- Design of experimental plans at laboratory and/or pilot scale to support issue resolution and improvements

PREFERRED QUALIFICATIONS:

- Experience with technical operations to support commercial API production
- Experience related to process development, process characterization, technology transfer, scale-up and/or manufacturing of chemical drug substance (API) processes in a cGMP environment.
- Understanding of regulatory and cGMP requirements and trends
- Familiar with analytical chemistry techniques and their application in Quality Control
- Able to apply engineering principles and statistical analysis, including design of experiments and statistical process control (SPC), in-order to solve processing issues and evaluate opportunities for process improvements

5 ESSENTIAL SKILLS INCLUDE:

1) Chemical engineering and chemistry knowledge

2) Technical writing and presentation skills

3) Being able to work in cross-functional teams and strong project management/communication skills

4) Knowledge of drug substance processing equipment, trains and best practices

5) Understanding of regulatory and cGMP requirements and trends

Michael Bailey International is acting as an Employment Business in relation to this vacancy.