Lead Process Scientist Drug Substance LANT

Summary & Purpose of the Position

• lead the process transfer of Drug Substance (DS) manufacturing process for new products from development to manufacturing
• ensure process knowledge and control strategies are appropriate to ensure Drug Substance processes operate in a reliable, cost effective, safe, and compliant manner
• ensure documentation is ready and available to support the process design Drug Substances ahead of Regulatory examination
• ensure any gaps in the process design and/or control strategy are identified
• Action any identified gaps and ensure they are closed as required prior to PPQ and commercial manufacture

Main Responsibilities & Technical Competencies

• Able to interrogate process monitoring and data analysis of the DS process. Identify areas of improvement or concern.
• Have a broad understanding of CMC activities, regulatory strategy, understand risks and be able to link actions to Manufacturing Science and Technology.
• SME in aspects of Drug Substance process.
• Presenting the review finding and proposed actions to address any gaps to stakeholders including Site Leadership team, BPD and the global MS&T team
• Able to perform technical/critical review of data from Drug substance process including Upstream and Downstream steps
• Provide guidance for the remediation of any gaps in design, optimization and implementation of DS manufacturing processes utilizing scientific principles, process, and product knowledge.
• Communicate project status to MS&T Management, TechOps Asset lead and other Key stakeholders via the appropriate escalation channels and project meetings.
• Challenge and influence stakeholders to drive alignment, secure commitment, and enable successful outcomes through informed, data driven decision-making and collaborative engagement.

Knowledge & Experience

Knowledge & Experience (essential):

• Able to use and apply scientific or engineering principles, theories and concepts.
• Knowledge of Drug Substance unit operations.
• Ability to define work plans, execute and provide technical updates to project teams

Knowledge & Experience (preferred):

• Provide effective and regular reporting, across CMC teams, project governance and senior management/stakeholders

Education / Certifications (essential):

• Degree level qualified in Scientific, Pharmaceutical or Engineering discipline

Education / Certifications (preferred):

• MSc or PhD in Scientific, Pharmaceutical or Engineering discipline