API MSAT Lead - Particle Engineering and Flow Chemistry

Biocon; Bengaluru; On-site; INR 4,000,000 - 8,500,000; Full time

Job summary

Biocon is seeking a seasoned leader to head the Particle Engineering and Flow Chemistry functions to enable robust API development, process optimization, and commercialization.

You will lead development and scale-up of milling, crystallization, and continuous flow chemistry, drive technology transfer, and build a high-performing team.

The role requires 15+ years in API/process development, strong leadership, and a track record in particle engineering and regulatory support.

Qualifications

• MTech / BTech / MSc in Chemical Engineering, Organic Chemistry, or related disciplines.
• 15+ years of API/process development experience in pharmaceutical industries.
• Expertise in particle engineering, crystallization, micronization, flow chemistry, scale-up and tech transfer.
• Strong leadership experience managing multidisciplinary teams.

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 CMAs and 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.

Skills

Particle engineering

Crystallization

Flow chemistry

Technology transfer

Leadership

Process development

Team mentoring

Education

MTech / BTech / MSc in Chemical Engineering, Organic Chemistry, or related disciplines

Tools

XRPD

DSC

TGA

SEM

BET

Laser Diffraction

Job description

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

• Crystallization & Polymorph Management
• Continuous Flow Chemistry & Process Intensification
• Process Development, Scale-up & Commercialization
• 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.