Process Engineering

7 days ago

Hyderabad, India PI Health Sciences Full time

Team Member – Particle Science & Engineering, Process Technology

Role: Team Member – Particle Science & Engineering


Position Title:

Assistant Manager – Particle Science & Engineering

Reporting to (Title): Lead – Process Technology

Position Purpose

The Particle Engineering Expert will lead salt and polymorph screening and optimization of crystallization processes to ensure the development of high-quality, pure, and reproducible crystalline Drug Substances. This role involves applying advanced techniques such as polymorph screening, PAT tools, and scale-down models to solve complex challenges. The position requires collaboration across teams to achieve desired crystal properties and ensure process scalability.


Strategic Responsibilities

Lead the development and implementation of innovative crystallization techniques and process control strategies, leveraging advanced tools like PAT and mathematical modelling, to enhance process efficiency, scalability, and product quality.


Operational Responsibilities

  • Lead salt and polymorph screening and selection process to identify optimal crystal forms, ensuring high solubility and stability.
  • Lead and oversee the development and optimization of crystallization processes for Intermediates & Drug substances (DS).
  • Design and perform experiments to generate solubility data to optimize crystallization conditions.
  • Develop particle engineering solutions to optimize particle size distribution, morphology, and other key properties impacting downstream processes.
  • Implement strategies to control polymorphism during crystallization and to achieve desired particle properties.
  • Collaborate closely with cross-functional teams, including chemistry and technology groups, to integrate emerging crystallization development technologies and strategies.
  • Apply PAT tools such as FBRM & PVM in conjunction with mathematical models to enhance process understanding and optimize crystallization outcomes, including achieving desired particle size distribution and polymorphism.
  • Lead the development and application of scaled-down models to replicate and solve complex crystallization challenges at the manufacturing scale.
  • Provide technical expertise in scaling crystallization processes from the lab to pilot and commercial production stages.
  • Serve as a technical expert, contributing to the success of multiple projects by providing expert advice and problem-solving in the area of crystallization.
  • Stay up to date with emerging technologies in crystallization and PAT, and introduce new methods to improve process efficiency, robustness, and scalability.
  • Experience in the use and scale-up of milling technologies (both dry and wet) for particle size control.
  • Knowledge of solid-state characterization techniques, such as XRD, DSC, and FTIR
  • Ensure proper documentation of crystallization process development, experimental data, and results in compliance with regulatory requirements.
  • Prepare and review technical reports, SOPs, and protocols for internal and client purposes.


Financial Responsibilities

  • Manage the crystallization development budget, ensuring efficient allocation of resources and identifying opportunities for cost reduction while maintaining high-quality standards in process development and scale-up
  • Provide accurate financial forecasts for crystallization-related projects, including resource planning, timeline management, and cost analysis, to ensure projects are completed within budget and meet profitability targets.

People Responsibilities

  • Collaborate with cross-functional teams, providing guidance and expertise in Particle Engineering.
  • Communicate effectively with team members, management, and other stakeholders, ensuring clear understanding of Particle Engineering objectives, initiatives, and outcomes.
  • Engage in collaborative problem-solving, working with the team to address challenges related to Crystallization development and promoting a solutions-oriented approach.

Education Qualification

  • Bachelor's or Master's degree in Chemical Engineering.

Work Experience

  • 8-10 years of experience in crystallization process development within the pharmaceutical industry, particularly in CDMO settings.
  • Extensive experience in salt and polymorph screening, crystallization behavior analysis (nucleation, growth, morphology), and particle engineering.
  • Proven expertise in the application of Process Analytical Technologies (PAT), including FBRM, PVM, and other tools for crystallization process monitoring and optimization.
  • Proficient in handling automated lab reactors like EasyMax, Optimax, and jacketed reactors to conduct real-time crystallization experiments, generate high-quality data, and monitor critical process parameters.
  • Demonstrated ability to solve complex crystallization challenges, both at the laboratory and manufacturing scales, through scaled-down models and process control strategies.

Functional Competencies

  • Expertise in developing, optimizing, and scaling crystallization processes, including salt and polymorph screening, particle engineering, and solid-state characterization, to meet product quality and regulatory standards
  • Proficient in data analysis, capable of drawing insightful conclusions from experimental findings, and skilled in preparing detailed reports to communicate outcomes effectively.

Behavioural Competencies

  • Ability to adapt to changing priorities, navigate unforeseen challenges, and maintain composure in dynamic laboratory environments.
  • Meticulous attention to detail in the execution of experiments, analysis of data, and preparation of documentation to ensure accuracy and reliability.
  • Efficient time management skills, ensuring the timely completion of tasks & projects.

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