Principle Scientist

1 day ago

Hyderabad, India Curateq Biologics Full time

Role & responsibilities

Position Summary:

We at CuraTeQ Biologics are seeking a 12-16 year experienced Principle Scientist to join our Downstream Research & Development (R&D) team focused on monoclonal antibodies (mAb) and therapeutic proteins. The ideal candidate will have a strong background in bioprocess development, specifically in downstream purification and analytics of monoclonal antibodies and related complex protein molecules. This role will involve designing, optimizing, and scaling purification processes to support pipeline candidates and commercial biologics.

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.

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