Senior Downstream Scientist (Biotechnology)

Job summary

This role involves supporting the manufacturing of commercial biotechnological products, focusing on downstream processes for complex biologics. The Senior Downstream Scientist will be responsible for driving technical excellence, managing process changes, and ensuring compliance with regulatory standards.

Qualifications

• MSc in Biochemistry, Chemistry, Biology, Bioprocess, or a related field with 6+ years of relevant pharmaceutical industry experience, or a PhD with 4+ years of experience.
• Solid understanding of downstream processing principles and hands-on experience with chromatography techniques, including affinity, ion exchange, hydrophobic interaction, and mixed-mode chromatography.

Responsibilities

• Act as the primary owner of technical documentation within the MSAT organization, ensuring accuracy and consistency.
• Lead process change management and post-batch evaluations, driving initiatives for efficiency and quality improvements.
• Author and review technical sections of regulatory dossiers and provide leadership during inspections and audits.
• Support technical operations deviations and investigations, contributing to critical decisions and project milestones.

Skills

• Strong data analysis capabilities with experience in statistical software such as JMP or Minitab.
• Extensive knowledge of Good Manufacturing Practices (GMP) and applicable regulations (ICH Q7A, 21 CFR Part 211).
• Proven ability to communicate effectively with internal and external clients and manage multiple projects simultaneously.

Education

• MSc or PhD in a relevant scientific field.

Tools

• Familiarity with chromatography systems such as ÄKTA and related software (UNICORN), as well as experience with ultrafiltration and diafiltration processes.