Senior Scientist, MSAT – Bioprocess Transfer & Validation

AGC Biologics A/S; København; On-site; DKK 800,000 - 1,050,000; Full time

Job summary

AGC Biologics, a global CDMO, seeks a Senior Scientist to lead technology transfer, validation, and manufacturing support within MSAT for late-stage and commercial biopharmaceutical projects. You will own projects with strong collaboration across Manufacturing, Quality, Regulatory, Project Management, and customers to ensure robust GMP processes.

You will analyze data, apply risk-based science, and contribute to continuous improvement while working in a GMP manufacturing environment.

Qualifications

• MSc in Biochemistry, Chemistry, Biology, Bioprocess Engineering or related field with 6+ years industry experience, or PhD with 4+ years.
• Strong experience in biopharmaceutical manufacturing and understanding of upstream/downstream processing.
• GMP documentation experience and regulatory familiarity.
• Experience with technology transfer, PPQ, risk assessments, process characterization, and manufacturing support.

Responsibilities

• Technology transfer from customers to manufacturing.
• Process mapping and facility fit assessments.
• Validation activities and PPQ preparation.
• Technical support before, during, and after manufacturing campaigns.

Skills

Bioprocessing

GMP knowledge

Project management

Stakeholder management

Education

MSc in Biochemistry

PhD in related field

Tools

ICH Q7A/21 CFR Part 211

Job description

AGC Biologics, a global CDMO, seeks a Senior Scientist to lead technology transfer, validation, and manufacturing support within MSAT for late-stage and commercial biopharmaceutical projects. You will own projects with strong collaboration across Manufacturing, Quality, Regulatory, Project Management, and customers to ensure robust GMP processes.

You will analyze data, apply risk-based science, and contribute to continuous improvement while working in a GMP manufacturing environment.