Teams at Pinnaql, Inc.

Lead end-to-end peptide process development and scale-up from R&D through first cGMP batches. Define technical direction, select equipment, establish process controls and analytical strategies, drive CMC content for regulatory filings, partner on facility design and commissioning, and build the process development/CMC organization post-Series A. Hands-on leadership with floor-level manufacturing involvement during scale-up and PPQ.

Provide technical support across the project lifecycle for pharmaceutical manufacturing: equipment assessment, capital project development, design review, installation support, verification (CQV), change controls, investigations, process improvements, and stakeholder coordination in GMP-regulated environments.

Provide technical engineering support for maintenance, validation, and compliance of utilities, process and cleanroom systems in pharma/biotech. Coordinate training, audits, investigations, regulatory inspection support, and system improvements; ensure cGxP and FDA standards are met.