API MSAT Lead - Particle Engineering and Flow Chemistry

Job Purpose

Lead the Particle Engineering and Flow Chemistry functions to enable robust API development, process optimization, technology transfer, and commercialization. Drive innovation in crystallization, PSD control, continuous manufacturing, and process intensification to support the generics portfolio.

Key Responsibilities

• Define and execute particle engineering strategies for PSD, crystal habit, polymorphism, flowability, and dissolution enhancement.
• Lead development and scale-up of milling, micronization, crystallization, and continuous flow chemistry processes.
• Establish scientific control strategies for critical material attributes (CMAs) and critical process parameters (CPPs).
• Drive conversion of conventional batch processes to continuous flow platforms where applicable.
• Support technology transfer, validation, and commercial troubleshooting activities.
• Collaborate with R&D, Tech transfer, Manufacturing, QC, QA, Regulatory and Commercial teams to ensure successful product development and commercialization.
• Build and mentor a high-performing team of scientists and engineers.
• Develop laboratory capabilities, equipment platforms, and innovation roadmaps.
• Support global regulatory filings with technical justifications and risk assessments.
• Ensure compliance with GMP, EHS, data integrity, and quality requirements.

Qualifications & Experience

• MTech. / B.Tech /M.Sc. in Chemical Engineering, Organic Chemistry, or related disciplines.
• 15+ years of experience in API/process development within pharmaceutical industries.
• Demonstrated expertise in particle engineering, crystallization, micronization, flow chemistry, scale-up, and technology transfer.
• Strong leadership experience managing multidisciplinary teams.

Technical Expertise

• Particle Engineering, PSD Control & Characterization
• Crystallization & Polymorph Management
• Jet Milling, Tap milling, Impact Milling, Cryogenic Milling
• Continuous Flow Chemistry & Process Intensification
• Process Development, Scale-up & Commercialization
• PAT, DOE, QbD, Risk Assessment
• XRPD, DSC, TGA, SEM, BET, Laser Diffraction

Key Success Metrics

• Successful commercialization of particle-engineered products.
• Implementation of innovative Particle engineering & flow chemistry technologies.
• Robust and scalable PSD/crystallization control strategies.
• Improved process efficiency, yield, quality, and cost competitiveness.
• Strong talent development and technical capability building.