The Senior Scientist role is responsible for aiding in the supply of strategic drug product technical expertise and support to a portfolio of established products. The products are manufactured either internally at an CLIENT'S manufacturing site or externally at a contractor. The technical expertise and support is used in problem solving as well as in continuous improvement activities.
This a great opportunity to learn about CLIENT'S's exciting and diverse established product portfolio and to gain experience working in a Global function and with external suppliers.
Responsibilities:
Support License to Operate activities:
-Provide technical expertise and problem solving support to the manufacturing sites.
-Provide technical expertise and support in creating regulatory documentation and responses to regulatory questions in a way that ensures maximum flexibility for Operations.
Support manufacturing and supply chain changes:
-Perform technical risk assessments for proposed changes, e.g. to excipients, packaging/device components, manufacturing processes and/or analytical testing methods.
-Propose experimental work to support changes
-Review generated data and make recommendations on whether to proceed with changes or not.
Maintain product knowledge:
-Write reports and memos to record technical investigations or recommendations, ensuring data integrity.
-Contribute to and/or coordinate Quality Risk Assessments and Technical Opportunity and Risk Assessments (TORAs) as required.
-Produce and maintain information in the Product Knowledge Management tool.
Coordinate, lead or support product improvement initiatives:
-As required, ensure delivery of product and process improvements that will deliver business benefits.
-Develop or support the manufacturing sites in developing business cases.
-Co-ordinate appropriate support teams if required
Maintain communication to product stakeholders:
-Work with Product Champions to receive work requests, perform priority assessments and agree level of effort on each activity
-Establish networks between sites who manufacture the same or similar products to ensure effective collaboration.
-Effectively communicate product performance and product issues to the manufacturing sites.
Build technical understanding and capability:
-Train manufacturing sites in, e.g. pharmaceutical technologies, formulation and packaging design, manufacturing and testing control strategies and analytical techniques as appropriate.
Minimum Requirements - Education and Experience (Required)
-BSc degree in a relevant discipline, e.g. analytical chemistry, chemical engineering or pharmaceutics
-Experience of pharmaceutical manufacturing/QC testing and/or research and development
-Knowledge of the overall drug development and commercialization process from development, launch and through life cycle management
-Experience working in one of the following disciplines: Analytical Science, Chemical Science, Formulation Science, Physical Science, Pharmaceutical Manufacturing and Supply Chain Management
-Knowledge of international GMP and SHE requirements and their applicability to pharmaceutical manufacturing, research and development
-Knowledge of Quality Management Systems and their applicability to pharmaceutical manufacturing
Minimum Requirements - Education and Experience (Desired)
-Masters Degree or PhD in a relevant discipline, e.g. analytical chemistry, chemical engineering or pharmaceutics
-Experience working in Global function and/or with external parties
-Experience working in more than one area of the overall drug development and commercialization process from development, launch and through life cycle management
-Experience working in two or more disciplines such as Analytical Science, Chemical Science, Formulation Science, Physical Science, Pharmaceutical Manufacturing and Supply Chain Management
-Extensive knowledge of international GMP and SHE requirements and their applicability to pharmaceutical manufacturing, research and development
-Extensive knowledge of Quality Management Systems and their applicability to pharmaceutical
Manufacturing