Teams at Serán BioScience, LLC

Leads analytical method development, optimization, validation, transfer, and lifecycle management for small-molecule drug products in a GMP environment. Performs testing using HPLC, GC, dissolution, water content, and water activity methods; supports QC laboratories, OOS/OOT investigations, discrepancy reports, and CMC decision-making. Prepares regulatory-ready documentation, collaborates cross-functionally, mentors teams, provides technical leadership, and drives analytical strategy and process improvements.

Oversee the proposal pipeline for new customers and projects, coordinating with business, technical, project management, and scheduling teams. Translate client needs into project scopes, timelines, costs, and pricing while ensuring proposal accuracy and quality. Support client discussions, RFI and RFP responses, sales efforts, proposal templates, costing templates, and continuous process improvement.

Oversee pharmaceutical quality assurance activities in a GMP facility, including supplier quality, internal and vendor audits, regulatory and client audit support, quality risk management, quality agreements, CAPA, investigations, change management, and continuous improvement. Author, review, and approve quality documents while administering quality systems and ensuring compliance with FDA and EMA expectations.