Downstream Process

Job Position: Downstream Processing

We are seeking a dedicated Scientist/Engineer specializing in downstream processing and purification of biomolecules, including proteins, antibodies, and nucleic acids. The successful candidate will develop, optimize, and scale-up purification processes to ensure high product yield and quality while adhering to regulatory standards. This role involves hands-on work with chromatography systems, filtration techniques, and process analytical tools.

Key Responsibilities

1. Purification Process Development

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• Design and optimize purification workflows for biomolecules using techniques such as chromatography, ultrafiltration/diafiltration (UF/DF), and precipitation.
• Evaluate and implement scalable purification strategies for production processes.

1. Chromatography Operations

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• Operate and troubleshoot chromatography systems (e.g., AKTA, TFF systems) for purification.
• Develop methods for ion exchange, size exclusion, affinity, and hydrophobic interaction chromatography.

1. Filtration and Concentration

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• Perform tangential flow filtration (TFF), ultrafiltration, and diafiltration for biomolecule concentration and buffer exchange.
• Assess filtration parameters to improve recovery and throughput.

1. Scale-Up and Technology Transfer

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• Optimize laboratory-scale processes for pilot and manufacturing scales.
• Collaborate with manufacturing teams to ensure seamless technology transfer and process scalability.

1. Analytical and Process Monitoring

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• Utilize analytical tools such as SDS-PAGE, HPLC, ELISA, and spectrophotometry for in-process monitoring and final product characterization.
• Implement process analytical technologies (PAT) to ensure process consistency and quality.

1. Documentation and Compliance

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• Maintain detailed records of experiments, protocols, and process development activities.
• Prepare standard operating procedures (SOPs), batch records, and regulatory documentation in compliance with GMP/GLP guidelines.

1. Collaboration and Teamwork

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• Work with upstream processing, quality assurance, and regulatory teams to ensure end-to-end process integration.
• Mentor and train junior team members in downstream techniques and best practices.

1. Innovation and Continuous Improvement

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• Stay updated on advancements in purification technologies and apply them to improve existing processes.
• Contribute to the development of novel purification strategies to enhance productivity and efficiency.

Qualifications and Skills

• Education

  : Master’s or Ph.D. in Biotechnology, Biochemistry, Chemical Engineering, or a related field.

• Experience

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• 3–5 years of experience in downstream processing and purification of biomolecules, preferably in a biopharmaceutical or biotechnology setting.
• Hands-on experience with chromatography and filtration systems.

• Technical Skills

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• Expertise in chromatography techniques, filtration methods, and biomolecule characterization.
• Familiarity with regulatory guidelines (ICH, FDA, EMA) for biopharmaceutical production.

• Soft Skills

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• Strong analytical and problem-solving abilities.
• Effective communication and documentation skills.
• Team-oriented with the ability to manage multiple projects.

Preferred Skills

• Experience with monoclonal antibodies (mAbs), recombinant proteins, or nucleic acids.
• Knowledge of high-throughput process development (HTPD) tools.
• Familiarity with single-use systems and continuous processing technologies.