- Establish and maintain a fully functional scale-up laboratory, ensuring equipment is properly set up, calibrated, and safe.
- Design and perform formulation development experiments to optimize processes for efficient scale-up and manufacture.
- Collaborate with cross-functional teams for smooth knowledge transfer from R&D to manufacturing, including on-site support as needed.
- Troubleshoot formulation and process issues in pilot and commercial production, adjusting mixing order, shear profile, and add-rate to meet specifications and optimize worker safety.
- Maintain accurate documentation of experiments, protocols, and all manufacturing activities; generate batch records and Certificates of Analysis (COAs).
- Plan, execute, and document small-scale production runs (1–40 L) using various laboratory equipment and conduct in-process controls (pH, specific gravity, viscosity, particle size, visual inspection, stability screening).
- Stage raw materials, verify identity and traceability, and package, label, and ship samples according to SOPs; manage pilot lot inventory and sample retention.
- Ensure compliance with safety, quality, and regulatory standards, following chemical handling procedures, PPE requirements, and GHS/SDS guidelines.
- Work with chemists to translate bench-scale methods into repeatable pilot SOPs and recommend process or equipment improvements.
- Uphold 5S principles in the pilot area, maintain preventive maintenance logs, and perform basic calibrations.
- Contribute to S&OP hand-off data, including yields, cycle times, critical parameters, and safety notes.
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