Senior Process Engineer, Technical Operations – Molecule Drug Product; Spray Drying

Senior Process Engineer, Technical Operations – Small Molecule Drug Product (Spray Drying)

We are seeking a Senior Process Engineer to lead technical operations for small molecule drug product manufacturing via spray drying at a state‑of‑the‑art site.

• Technical & Process Leadership
  • Provide leadership for drug product intermediate manufacturing processes including spray drying (solution and suspension), particle engineering, powder handling, isolation, post‑processing, and downstream processing into dosage forms.
  • Own and act as SME for spray drying and associated unit operations, leading technical input to the Capital Project Team: equipment selection, process design and control strategy, commissioning, qualification, and startup readiness.
  • Lead or coordinate process scale‑up, technology transfer, and validation activities, such as PPQ.
  • Interpret process and material data (PSD, morphology, residual solvent, solid‑state properties) to support data‑driven decision making.
  • Provide advanced troubleshooting support for spray drying and powder‑handling challenges (yield losses, sticking, fouling, variability in particle attributes).
  • Drive technology transfer and commercialization for spray‑dried intermediates, partner with R&D and network sites, and lead process fit and scalability assessments.
  • Own or guide development and optimization of batch documentation, process descriptions and control strategies, and support industrialization of new particle‑engineering technologies.
  • Lead continuous improvement initiatives, using structured problem‑solving approaches (RCA, DoE) to address variability, equipment challenges, and downstream processing impacts.
  • Monitor process trends and critical quality attributes to identify risks and optimization opportunities.
• Process Optimization & Operational Excellence
  • Partner with Manufacturing to ensure safe, efficient, and reliable spray‑drying operations.
  • Identify, prioritize, and implement improvements in particle consistency, process robustness, yield, throughput, and cycle time.
  • Drive debottlenecking, cleaning optimization, and campaign efficiency improvements.
• Compliance & Documentation
  • Ensure all activities comply with cGMP, safety (ATEX/containment where applicable), and environmental standards.
  • Lead campaign preparation, execution, and post‑campaign review.
  • Own or approve batch records, process specifications, and control strategies for intermediates.
  • Support regulatory inspections and audits, ensuring inspection‑ready processes and documentation.
  • Maintain data integrity for materials characterization and process data.
• Cross‑Functional Collaboration & Influence
  • Act as technical representative across Manufacturing, Quality, Engineering, Supply Chain, and R&D.
  • Provide clear technical direction and influence decision‑making for product introduction and lifecycle management.
  • Lead or contribute to cross‑functional initiatives, fostering alignment and execution.
  • Support knowledge sharing and best practice transfer across internal and external networks.

• Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline.
• Typically 5+ years of experience in drug product intermediate, spray drying, or pharmaceutical process development/manufacturing (PhD may offset experience).
• Strong experience in spray drying and/or particle engineering processes.
• Understanding of scale‑up principles for spray dryers (lab to commercial scale).
• Experience in solid‑state characterization and material science (PSD, morphology, amorphous/crystalline control).
• Demonstrated involvement in technology transfer, process validation (PPQ), and commercial manufacturing support.
• Working knowledge of cGMP and regulatory expectations.
• Experience with downstream processing into drug product (blending, compaction) is desirable.

• Strong analytical capability with ability to interpret process and material science data.
• Demonstrated ability to lead technical work streams or process‑focused projects.
• Excellent problem‑solving skills with structured, science‑based approach.
• Effective communicator able to influence cross‑functional stakeholders.
• Proven ability to manage…