Principle Scientist - Downstream R&D

Role & responsibilities

Position Summary:

Principle Scientist

Key Responsibilities:

• Lead early-stage process development and optimization of downstream purification processes, including chromatography, filtrations, and viral clearance steps for monoclonal antibodies and proteins.
• Design the experiments for process development, characterization at lab scale.
• Develop scale-up strategies from lab to pilot scale, ensuring robust and reproducible processes.
• Collaborate closely with upstream R&D, analytical teams, and manufacturing to align process development activities.
• Generate and analyse process data, maintaining rigorous documentation and reporting results for internal and regulatory use.
• Ensure compliance with cGMP and regulatory guidelines during process development activities.
• Contribute to technology transfer and support technical assessments in manufacturing troubleshooting and process improvements.
• Mentor a team of scientists and researchers, promoting knowledge sharing within the R&D team.

Required Qualifications:

• Masters degree in biotechnology, Biochemical Engineering, Biochemistry, Molecular Biology, or related life sciences discipline.
• 12-16 years of industrial experience in biologics downstream process development, preferably with monoclonal antibodies.
• Hands-on expertise in protein purification techniques (e.g., Protein A affinity chromatography, ion exchange, hydrophobic interaction chromatography, filtration methods).
• Familiarity with upstream/downstream integration and process analytical technologies (PAT).
• Strong analytical skills with experience using protein characterization tools such as HPLC, SDS-PAGE, ELISA, SEC, and other biophysical techniques.
• Demonstrated ability to handle complex problem-solving, process scale-up, and optimization.
• Experience with viral clearance studies and regulatory documentation preferred.
• Excellent written and verbal communication skills; proficiency in English.
• Strong team player with ability to work cross-functionally in a fast-paced environment.

Preferred candidate profile

Preferred Skills:

• Experience working in biopharmaceutical or contract development and manufacturing organizations (CDMOs).
• Knowledge of quality by design (QbD) and process validation principles.
• Familiarity with data analysis tools such as JMP, Minitab or similar statistical software.
• Exposure to emerging purification technologies.