Senior Scientist

Job Description

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.

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.

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.

• 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

• 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