Senior Scientist, MSAT & Tech Transfer

AGC Biologics; København; On-site; DKK 750,000 - 1,100,000; Full time

Job summary

AGC Biologics seeks a Senior Scientist to lead late-stage MSAT efforts, overseeing technology transfer, process validation, PPQ, and manufacturing support for commercial biopharmaceutical projects. You will drive data-driven optimization across cross-functional teams and customer collaborations.

You will work in a GMP environment, applying risk-based thinking to solve complex technical challenges, with broad exposure to regulatory interactions and project leadership across global sites.

Qualifications

• MSc with 6+ years of industry experience or PhD with 4+ years in the field.
• Strong experience with upstream and/or downstream biopharmaceutical processing, esp. mammalian expression systems.
• GMP experience with ICH Q7A and 21 CFR Part 211.

Responsibilities

• Lead technology transfer from customers into manufacturing and support PPQ activities.
• Perform process validation, risk assessments, and process characterization across campaigns.
• Analyze manufacturing data using scientific insight to improve robustness.
• Coordinate activities across Manufacturing and GMP functions; manage multiple projects.
• Represent MSAT in customer meetings, audits, and regulatory interactions.

Skills

Biopharma manufacturing

Technology transfer

PPQ

Process validation

Risk assessments

GMP documentation

Stakeholder management

English communication

Education

MSc in Biochemistry/ Chemistry/ Biology/ Bioprocess Eng or related

PhD in related scientific or engineering discipline

Job description

AGC Biologics seeks a Senior Scientist to lead late-stage MSAT efforts, overseeing technology transfer, process validation, PPQ, and manufacturing support for commercial biopharmaceutical projects. You will drive data-driven optimization across cross-functional teams and customer collaborations.

You will work in a GMP environment, applying risk-based thinking to solve complex technical challenges, with broad exposure to regulatory interactions and project leadership across global sites.