Job Description
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.
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.
- 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.