Scientist - Process Development Immunoassay

You are a detail-oriented engineer or scientist with a strong foundation in biological or chemical sciences and a growing depth of experience in immunoassay scale-up and technology transfer. You are motivated, analytical, and comfortable bridging the gap between R&D innovation and commercial manufacturing within a fast-paced, regulated environment. You bring hands-on experience navigating cGMP or ISO 13485 guidelines, possess a natural knack for rigorous technical writing, and are eager to take on greater technical ownership of QMS workflows, process improvements, and manufacturing transitions.

Lead technology transfer and scale-up activities for immunoassay-based products (e.g., ELISA, lateral flow) from development/pilot scale to commercial GMP manufacturing.

Author and optimize technical documentation required for manufacturing, including Batch Production Records (BPRs), Master Batch Records (MBRs), Standard Operating Procedures (SOPs), and Tech Transfer Reports.

Manage QMS workflows by leading technical investigations for process deviations, Out of Specification (OOS) results, and implementing corrective and preventive actions (CAPAs).

Drive process improvement and optimization efforts to enhance assay robustness, scale-up yield, and manufacturing reproducibility using root-cause analysis (RCA) and data-driven methodologies.

Ensure strict compliance of manufacturing processes and transfer workflows with cGMP and ISO 13485 regulatory standards.

Design, execute, and analyze experiments specifically geared toward process validation, scale-up modeling, and bridging studies.

Collaborate cross-functionally as the primary technical bridge between R&D, Quality Assurance, Engineering teams, and Manufacturing Operations to ensure seamless product scaling and timeline adherence.

Provide hands-on technical support during manufacturing scale-up, validation runs and troubleshooting campaigns.