Senior Process Engineer, Technical Operations - Small Molecule Drug Substance

Role: Senior Process Engineer, Technical Operations – Drug Substance, responsible for providing technical leadership and process ownership across API manufacturing, including chemical synthesis, purification, crystallization, and drying. Responsibilities: support facility design, commissioning, qualification, technology transfer, validation, troubleshooting, process optimization, and continuous improvement; lead or support technology transfer and process scale-up; ensure process robustness, quality, and efficiency; maintain cGMP compliance, contribute to regulatory inspections, and manage documentation. Requirements: degree in Chemical Engineering, Chemistry, or related field; 5+ years in API manufacturing, process development, or pharma operations; experience with process transfer, validation, troubleshooting, and scale-up; strong data analysis and problem-solving skills; knowledge of cGMP standards. Preferred: experience in small molecule APIs at commercial scale, cross-functional collaboration, and process automation tools. High-value: focus on small molecule API manufacturing, technology transfer, process validation, cGMP compliance, and operational excellence. Collaboration: work within a cross-functional team supporting manufacturing, quality, engineering, R&D, and supply chain. Work setup: on-site with 10% travel; based at a new small molecule production facility in the U.S., designed for rapid technology transfer and commercial manufacturing.