Senior Process Engineer, Technical Operations - Molecule Drug Substance

We have an exciting opportunity for a Senior Process Engineer, Technical Operations – Drug Substance to join our growing team. At our company, we aspire to be the premier research‑intensive biopharmaceutical company, using the power of leading‑edge science to save and improve lives worldwide. The role is based at a purpose‑built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the United States.

• Technical & Process Leadership
  • Provide technical leadership for API manufacturing processes, including chemical synthesis, purification and isolation, crystallization and drying operations.
  • Act as process owner / SME for assigned unit operations, equipment, or product processes.
  • 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 (e.g., pre‑PPQ, PPQ).
  • Analyze and interpret process data to drive data‑driven decision‑making and performance improvements.
  • Provide advanced troubleshooting support during manufacturing campaigns, resolving complex technical issues.
• Technology Transfer & Commercialization
  • Lead or play a key role in executing technology transfers for new products and processes into the facility.
  • Partner with global R&D and network sites to ensure robust process knowledge transfer and right‑first‑time startup.
  • Drive process fit assessments, scale‑up strategy, and manufacturability evaluations.
  • Own or guide development and optimization of batch documentation and process instructions.
  • Support integration and industrialization of new technologies into manufacturing operations.
• Process Optimization & Operational Excellence
  • 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.
• Compliance & Documentation
  • Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards.
  • Provide technical leadership in campaign preparation, execution, and post‑campaign review.
  • 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.
• Cross‑functional Collaboration & Influence
  • Act as a technical representative within cross‑functional teams including Manufacturing, Quality, Engineering, Supply Chain, and R&D.
  • Provide clear technical direction and influence decision‑making across projects and operations.
  • Lead or contribute to cross‑functional initiatives, driving alignment and delivery of key milestones.
  • Support knowledge sharing and best‑practice transfer across the network.

• 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.

• Strong analytical capability with ability to interpret complex data and drive decisions.
• Demonstrated ability to lead technical work streams or projects.
• Excellent problem‑solving skills with structured, science‑based approach.
• Effective communicator with ability to influence cross‑functional stakeholders.
• Proven ability to manage multiple priorities and deliver results…