Senior Scientist, Biopharma Process Transfer & Validation

AGC Biologics, Inc.; København; Hybrid; DKK 700,000 - 950,000; Full time

Job summary

AGC Biologics, Inc. is seeking a Senior Scientist for the MSAT group to drive technology transfer, validation, and manufacturing support in a GMP setting. You will own complex technical challenges and collaborate with Manufacturing, Quality, Regulatory, Project Management, and clients.

The role focuses on late-stage MSAT work, process mapping, PPQ, and data-driven improvements across mammalian bioprocessing, with cross-functional representation in customer meetings and audits.

Qualifications

• MSc or PhD with 4+ years in biopharma manufacturing.
• Experience with upstream/downstream processing.
• GMP regulations and guidelines (ICH Q7A, 21 CFR Part 211).
• Experience with tech transfer, process validation, PPQ and risk assessments.
• Experience authoring GMP documentation and leading cross-functional teams.

Responsibilities

• Lead technology transfer from customers into manufacturing.
• Perform process mapping and facility fit assessments.
• Drive validation activities and PPQ preparation.
• Provide technical manufacturing support during campaigns.
• Analyze process data with risk-based approaches.
• Collaborate across Manufacturing, Quality, Regulatory and Project Management.
• Represent MSAT in customer meetings and regulatory inspections.

Skills

Biopharma manufacturing

Technology transfer

Process validation

PPQ (Process Performance Qualification

Risk assessment

Documentation & compliance

Stakeholder management

Communication skills

English proficiency

Education

MSc in Biochemistry / Chemistry / Biology / Bioprocess Engineering

PhD in related field

Tools

Mammalian expression systems

Job description

AGC Biologics, Inc. is seeking a Senior Scientist for the MSAT group to drive technology transfer, validation, and manufacturing support in a GMP setting. You will own complex technical challenges and collaborate with Manufacturing, Quality, Regulatory, Project Management, and clients.

The role focuses on late-stage MSAT work, process mapping, PPQ, and data-driven improvements across mammalian bioprocessing, with cross-functional representation in customer meetings and audits.