Scientist - R&D Downstream

Job Title: Scientist Downstream R&D

Job Summary:

We are looking for a Scientist Downstream R&D to lead the development and optimization of protein purification processes. The role involves chromatography, ultrafiltration, filtration, and process scale-up to ensure efficient and scalable downstream processing. The candidate will collaborate with cross-functional teams to support process development, technology transfer, troubleshooting, and regulatory documentation.

Qualifications:

• Masters in Biotechnology, Biochemistry, or a related field with 8-10 years of industry experience.
• PhD in Biotechnology, Biochemistry, or a related field with 4- 6 years of industry experience.

Roles & Responsibility:

• Technical Expertise:
• Extensive experience in protein purification, chromatography (KTA), ultrafiltration, and TFF.
• Strong understanding of bioprocess engineering, process scale-up, and automation.
• Soft Skills: Analytical mindset, problem-solving ability, and strong collaboration skills.
• Preferred: Experience with DOE, statistical analysis, and high-throughput screening is a plus.

• Key Responsibilities:

Protein Purification & Process Development:

• Develop and optimize chromatography-based purification (affinity, ion exchange, size exclusion), ultrafiltration, and filtration techniques.
• Design and execute experiments for process characterization, yield improvement, and cost efficiency.
• Implement high-throughput screening and automation-based purification strategies.

Scale-Up & Technology Transfer:

• Lead process scale-up from laboratory to pilot and manufacturing scales.
• Support technology transfer, process validation, and regulatory documentation.

Process Characterization & Troubleshooting:

• Investigate process deviations, troubleshoot purification challenges, and implement corrective actions.
• Enhance process robustness and reproducibility through optimization studies.

Regulatory Compliance & Documentation:

• Maintain detailed experimental records, write technical reports, and contribute to cGMP, ICH, FDA regulatory documentation.

Collaboration & Cross-Functional Interaction:

• Work closely with Upstream, Analytical, and Formulation teams to ensure smooth process integration.
• Participate in cross-functional discussions to drive efficiency and innovation.

Process Optimization & Innovation:

• Apply Design of Experiments (DOE) and statistical analysis for process development.
• Explore new purification strategies, automation, and continuous processing techniques.