Summary/ Overview

Bioplus Life Sciences is seeking a seasoned Head – API Process Design and Engineering (Fermentation) person to lead process innovation, scale-up, and technical operations at its API manufacturing facility. This strategic leadership role bridges R&D and commercial manufacturing, focusing on robust, scalable, and compliant fermentation and purification processes aligned with US FDA and EU GMP standards.

Key Responsibilities

• Lead design, scale-up, and optimization of fermentation and downstream purification processes for biopharmaceutical APIs
• Oversee bioreactor design, equipment selection, qualification, and lifecycle management
• Drive yield improvement, debottlenecking, automation (DCS/SCADA), PAT, and Industry 4.0 initiatives
• Ensure compliance with US FDA, EU GMP, and ICH guidelines during validation, tech transfer, and audits
• Partner with R&D, Quality, and Supply Chain for seamless technology transfer and commercialization
• Manage CAPEX projects, engineering budgets, and mentor high-performing technical teams
• Proficiency in process simulation tools, equipment qualification (IQ/OQ/PQ), and regulatory inspections