
Scientist - R&D Downstream
1 week ago
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.
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