Pharmaceutical Manufacturer and Developer requires an experienced Research and Development Chemist.
About the role:
An opportunity to join a dynamic, market leading company in an innovative role to develop and enhance our portfolio of active pharmaceutical ingredients derived from botanical extracts. To develop and validate analytical methods to support our growing expansion of our core business.
This role is an integral part of the vision and ambition of the company. The successful candidate will help ensure that new products are appropriately developed and validated within a cGMP environment and successfully introduced to commercial production continuing the strong growth of our pharma business.
Duties may include:
• Develop control strategies appropriate for Active Pharmaceutical Ingredients (API's) via Quality by Design (QbD) principles.
• Work closely with Production, Research and Quality functions to ensure processes are developed and implemented in time to meet project/customer deadlines.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Demonstrate excellent communication skills (verbal and written).
• Ability to develop and give presentations on technical topics.
• Ability to train/mentor associates.
• Ability to use trends and data to review and improve performance.
Skills and experience:
• Degree in Chemistry or equivalent.
• Strong knowledge of the principles of QbD and control strategies.
• Experience of process development and validation as per ICH requirements.
• Technology transfer of newly developed processes to production team both internally and externally.
• Setting specification for critical parameters, raw materials, in-process checks and finished product.
• Knowledge of general process development used for herbal API's will be advantageous.
• Previous use of HPLC, GC, IR, UV and TLC desirable.
• Previous experience of risk assessment and failure mode effect analysis (FMEA) desirable
Certified Global Meeting Planner
Quality By Design (Qb D)
Failure Mode Effects Analysis