Job Description
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
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