Responsibilities

• Ensure security of supply to support clinical and commercial requirements from raw materials through to QP release and supply of product, in line with all relevant guidelines (GMP, GLP, GCP), from a fully outsourced supply chain
• Manage the negotiation, contracting and management of outsourced CMC activities, ensuring maximum productivity in terms of quality and cost
• Lead and manage outsourced services to ensure best performance and business relationships (requiring both technical expertise and business acumen)
• Identify, assess and implement new suppliers into outsourced supply chain
• Work with Legal to negotiate and implement new contracts (TA's, Supply Agreements (commercial and development) to add value to the portfolio
• Forecasting and inventory management
• Provide expert due diligence support for in- and out-licensing products as required
• Provide specialised technical CMC input to project teams, including defining and implementing product development plan to ensure optimum target product profile is met and maximising value
• Support regulatory filing's (IND, IMPD, NDA, BLA), including preparing CMC sections as required
• Support setting of CMC budgets and ensure adherence to this budget throughout the product lifecycle.

• Experience in pharmaceutical development and manufacturing
• Excellent understanding and hands-on working knowledge of cGMP, quality and regulatory requirements for clinical and commercial material
• Demonstrated ability to successfully manage outsourced manufacturing and QC contractors
• The position requires a degree in a relevant scientific discipline.