Senior Scientist - Animal Health

Role Summary

Senior Scientist – Downstream Process Development. The successful candidate will have a deep understanding of downstream process unit operations and hands-on experience with chromatography systems such as AKTA. This role requires a PhD or 5+ years of industry experience in the relevant field, strong problem-solving skills, and the ability to work with external partners.

Responsibilities

• Lead the development and optimization of the downstream processes for the purification of monoclonal antibodies or related antibody products.
• Design and execute experiments to evaluate and improve process performance.
• Utilize chromatography systems (e.g., AKTA and Unicorn software) and other purification techniques to achieve the desired purity and yield.
• Develop and implement robust and scalable processes for technology transfer to external partners or internal manufacturing.
• Process and produce materials at bench or pilot scale to support pre-clinical and clinical studies.
• Collaborate with cross-functional teams, including cell line development, upstream, analytical, formulation, clinical, regulatory, sourcing and manufacturing.
• Engage with external partners and stakeholders to ensure alignment and successful project execution and deliverables.
• Conduct root cause analysis and assay optimization individually or in a group setting
• Manage and leverage the resources within the team and department to ensure on-time delivery of project timeline and milestones.
• Stay informed of external advances and technologies for continuous improvement of the process and expansion of capabilities.
• Provide coaching or assistance to other team members.

Qualifications

• Required: Deep understanding of each unit operation in the downstream process, including chromatography, filtration, and ultrafiltration/diafiltration.
• Required: Broad knowledge and understanding of the interaction of the downstream process with product quality including the purity, impurity and potency.
• Required: Hands-on experience with AKTA or similar chromatography systems.
• Required: Strong problem-solving skills and the ability to troubleshoot and optimize processes.
• Required: Excellent communication and teamwork abilities.
• Required: Proven track record of successful process development and technology transfer in the industry setting.
• Preferred: Knowledge and experience with different recombinant protein expression and purification system at industry scale.
• Preferred: Knowledge and experience in recombinant protein developability and manufacturability assessment.
• Preferred: Knowledge in process scale up, scale down, process characterization, qualification and validation.
• Preferred: Knowledge and experience using DOE approach in process development.
• Preferred: Familiarity with Good Manufacturing Practices (GMP) and regulatory guidelines (e.g., FDA, EMA).
• Preferred: Experience working with external partners and managing collaborative projects.

Education

• Master's degree in Biochemistry, Biotechnology, Chemical Engineering, or a related field, with minimum 5 years of industry experience in downstream process development, OR PhD in Biochemistry, Biotechnology, Chemical Engineering, or a related field.

Skills

• Adaptability
• Assay Development
• Biochemical Analysis
• Biochemical Assays
• Biotechnology
• Chemical Engineering
• Chromatography
• Design of Experiments (DOE)
• Detail-Oriented
• Drug Target Identification
• Flow Cytometry
• Good Manufacturing Practices (GMP)
• Immunoassays
• Immunochemistry
• Immunology
• Molecular Biology
• Monoclonal Antibodies
• Personal Initiative
• Polyclonal Antibody Production
• Production Process Development
• Protein Expression
• Protein Purifications
• Teamwork

Additional Requirements

• Travel: 10%