MSAT Engineer (Process Chemist)

Responsibilities
Process Optimization and Monitoring:

• Perform laboratory scale experiments to support manufacturing non-conformances and lead continuous improvement projects (CIPs) including impurity purging capability, yield improvement, cycle time reduction and particle size distribution (PSD) optimisation.
• Serve as the Subject Matter Expert (SME) for Process Analytical Technology (PAT) initiatives, including plant-based MID-IR and Lasentec (FBRM) technology for monitoring critical parameters.
• Mobilize cross-functional teams to deploy live Multivariate Analysis (MVA) models, facilitating continuous process improvement.

Investigations and Innovation:

• Act as the Technical Process SME for Manufacturing Operations, providing expertise on investigations related to impurity deviations, low yields, emulsions, and PSD issues, while ensuring compliance with cGMP standards.
• Collaborate with internal and external stakeholders, including Regulatory Owners and Technical Owners, to support investigations, change controls, and CAPA development.
• Lead complex investigations with cross-functional teams, applying analytical and problem-solving skills to determine root causes, assess impacts, and implement process improvements.

Requirements

• PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
• Minimum of 3 years of experience in a similar role within the pharmaceutical industry or equivalent.
• Experience in PAT techniques, MVA, and process optimization methodologies preferred.
• Strong understanding of cGMP regulations and experience in supporting investigations and regulatory audits.
• Excellent communication and collaboration skills, with the ability to lead cross-functional teams and drive process improvement initiatives.
• Demonstrated leadership abilities, including experience in project management and team coordination.