Job Title: API Process Engineering Director
Job Description:
We are seeking an experienced leader to drive the development and implementation of small-molecule API manufacturing processes across batch and continuous platforms. As our API Process Engineering Director, you will be responsible for designing, scaling, and controlling API processes from clinical development through commercial supply.
Responsibilities:
* Lead the Small Molecules API Manufacturing Sciences activities within Global Process Science
* Provide process engineering support for batch and continuous API platforms from clinical through commercial stages
* Apply mechanistic modelling, process simulation, and quantitative analysis to enhance process understanding and enable robust process control
* Lead API manufacturing process characterization, including risk assessments and definition of critical process parameters and controls
* Lead technology transfer of API processes between internal sites and external CMOs
* Develop and implement strategies for continuous improvement of marketed API processes
* Establish and maintain systems and procedures for best practice in commercial technology transfer and process validation
* Collaborate closely with GMS functions, site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC
Requirements:
To succeed as our API Process Engineering Director, you should have a Master's degree in Chemical Engineering, Process Engineering, or Pharmaceutical Engineering, with at least 5 years of experience in a cGMP manufacturing environment and 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, ICH guidelines, and current global regulatory requirements relevant to API processes
* Demonstrated experience in mechanistic modelling, process simulation, and data-driven process optimization
* Proven track record leading API process characterization, technology transfer, process validation, and lifecycle changes in a multi-site or global context
* Strong problem-solving, project management, and stakeholder management skills
* Excellent written and verbal communication skills
* Ability to work independently and proactively while collaborating effectively within multi-disciplinary teams
* Commitment to sharing knowledge across functions and sites and to building sustainable technical capabilities in the organization
Benefits:
As our API Process Engineering Director, you will have the opportunity to work on complex issues, build a central knowledge base of API process and product understanding, and collaborate closely with cross-functional teams.
What We Offer:
* Competitive salary and benefits package
* Opportunities for professional growth and development
* Collaborative and dynamic work environment
* Recognition and rewards for outstanding performance
Join us in shaping the future of API manufacturing and driving innovation in the pharmaceutical industry.