Description

In this role, you will be the go-to expert for small-molecule API manufacturing, applying engineering skills to enhance processes from clinical development to commercial supply. The work involves leading technology transfers, process validations, and continuous improvements, while collaborating with various teams to ensure compliance and efficiency.

Requirements

• •Master's degree in Chemical Engineering, Process Engineering, or Pharmaceutical Engineering
• •At least 5 years of experience in cGMP manufacturing environment
• •At least 5 years of pharmaceutical industry experience in small-molecule APIs
• •Strong foundation in organic/pharmaceutical chemistry and chemical engineering
• •In-depth understanding of pharmaceutical manufacturing processes and ICH guidelines
• •Experience in mechanistic modelling, process simulation, and data-driven process optimization
• •Proven track record leading API process characterization and technology transfer
• •Strong problem-solving, project management, and stakeholder management skills
• •Excellent written and verbal communication skills
• •Ability to work independently and collaboratively in multi-disciplinary teams
• •Commitment to sharing knowledge across functions and sites
• •Intellectual curiosity about technology and new ways of working
• •Willingness to travel to international manufacturing sites

Tasks

• •Lead small molecules API manufacturing sciences activities
• •Provide process engineering support for batch and continuous API platforms
• •Apply mechanistic modelling and process simulation to enhance process understanding
• •Characterize API manufacturing processes, including risk assessments
• •Define critical process parameters and controls
• •Oversee technology transfer of API processes between internal sites and external CMOs
• •Ensure compliant implementation of API processes
• •Lead API process validation activities, including strategy and protocol design
• •Support execution and data evaluation for process validation
• •Develop strategies for continuous improvement of marketed API processes
• •Optimize yield and improve robustness while reducing cost of goods
• •Establish best practices for commercial technology transfer and process validation
• •Build and maintain a central knowledge base of API processes
• •Share lessons learned across products, sites, and functions
• •Collaborate with GMS functions and site leadership
• •Provide technical support for marketing applications in global markets
• •Prepare responses to regulatory questions from health authorities
• •Utilize root cause analysis techniques for process and equipment issues
• •Deliver sustainable corrective and preventive actions
• •Provide subject matter expertise for due diligence in mergers and acquisitions