Company Overview

Role Purpose

Academic Stream

Work experience (in months)

Job Responsibility and key Decisions

Downstream Process Development Optimization

a. Lead the design and execution of experiments to optimize purification processes for biologic drug substances, including chromatography, filtration, and concentration techniques.

b. Evaluate and optimize process parameters to enhance product yield, purity, and reproducibility while ensuring scalability for commercial production.

c. Implement and refine downstream purification strategies, incorporating the latest advancements in bioprocess engineering.

d. Troubleshoot and resolve processrelated challenges, optimizing efficiency while maintaining product quality and consistency.

Data Analysis Process Efficiency

a. Analyze experimental data to assess process efficiency, yield, and purity, ensuring all results align with product development goals.

b. Conduct comparability studies for process modifications, ensuring alignment with regulatory expectations for biosimilarity and CMC Chemistry, Manufacturing, and Controls requirements.

c. Provide technical expertise in purification techniques and process characterization, ensuring robust and reproducible outcomes.

Method Development, Qualification, ScaleUp

a. Drive the development, optimization, and scaleup of downstream processing methods, ensuring seamless transition from labscale to pilotscale and eventually to commercial production.

b. Collaborate with manufacturing and tech transfer teams to ensure that downstream processes are scalable, reproducible, and costeffective.

c. Support the qualification of purification methodologies and process parameters to ensure compliance with GMP and regulatory standards.

CrossFunctional Collaboration Communication

a. Work closely with Upstream Process Development, Analytical Sciences, Formulation Development, and Regulatory Affairs teams to ensure alignment in process development and product quality.

b. Act as a key technical liaison with manufacturing teams to ensure a smooth transition of downstream processes into GMP production.

c. Provide technical guidance and support for regulatory submissions, responding to queries from regulatory agencies regarding downstream process development.

Compliance Documentation

a. Ensure strict adherence to Good Documentation Practices GDP, maintaining comprehensive and auditready documentation for all process development activities.

b. Ensure compliance with GMP, ICH, FDA, EMA, and CDSCO guidelines throughout the downstream development process.

c. Support internal and external audits, providing technical justifications and datadriven responses to regulatory inquiries.

Team Leadership Talent Development

a. Lead and mentor a team of scientists and engineers, fostering a collaborative and innovationdriven culture.

b. Provide training in downstream processing techniques, data analysis, and process optimization to enhance team expertise.

c. Encourage a continuous improvement mindset, driving innovation in downstream processing methodologies.