Senior Process Engineer, Technical Operations - Small Molecule Drug Substance

About the role

We are seeking a Senior Process Engineer, Technical Operations – Drug Substance to join our growing team. This role offers the opportunity to lead technical and process excellence in a dynamic, forward-thinking environment.

Responsibilities

• Provide technical leadership for API manufacturing processes, including chemical synthesis, purification, and crystallization.
• Lead technical input to the Capital Project Team, supporting design reviews, commissioning, qualification, and startup readiness.
• Lead or coordinate process scale-up, technology transfer, and validation activities.
• Analyze and interpret process data to drive data-driven decision-making and performance improvements.
• Resolve complex technical issues during manufacturing campaigns.
• Partner with global R&D and network sites to ensure robust process knowledge transfer and right-first-time startup.
• Own or guide development and optimization of batch documentation and process instructions.
• Support integration and industrialization of new technologies into manufacturing operations.
• Partner with Manufacturing to ensure safe, efficient, and reliable plant performance.
• Identify, prioritize, and implement improvements in process robustness, product quality, yield, and throughput.
• Lead or drive continuous improvement initiatives aligned with operational excellence objectives.
• Use structured problem-solving approaches (e.g., RCA) to resolve deviations and recurring issues.
• Monitor process performance, trends, and cycle times to proactively identify risks and opportunities.
• Contribute to debottlenecking, cleaning, and turnaround optimization strategies.
• Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards.
• Own or approve key batch record updates and process documentation improvements.
• Support regulatory inspections and audits, providing technical input and ensuring inspection readiness.
• Ensure high standards of data integrity and technical documentation quality.

Qualifications

• Minimum of a degree in Chemical Engineering, Chemistry, or related discipline.
• Typically 5+ years’ experience in API manufacturing, process development, or pharmaceutical operations (PhD may offset experience).
• Strong experience in API processing operations and scale-up to commercial manufacturing.
• Demonstrated involvement in technology transfer, validation, and process support.
• Good understanding of cGMP manufacturing and regulatory expectations.
• Experience in troubleshooting and process optimization in a manufacturing environment.

Key Skills

• Strong analytical capability with ability to interpret complex data and drive decisions.
• Demonstrated ability to lead technical workstreams or projects.
• Excellent problem-solving skills with structured, science-based approach.
• Effective communicator with ability to influence cross-functional stakeholders.
• Prominent ability to manage multiple priorities and deliver results in a dynamic environment.
• Proactive, self-driven mindset with strong focus on continuous improvement and ownership.