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 ():

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 ():

MSc or PhD in Scientific, Pharmaceutical or Engineering discipline