Drug Substance Tech Transfer Lead — Hybrid Denmark

FUJIFILM Diosynth Biotechnologies; Hillerød; Hybrid; DKK 1,200,000 - 1,500,000; Full time

Benefits offered by this job

Hybrid work arrangement

Equal Opportunity Employer

Job summary

FUJIFILM Biotechnologies Denmark is seeking a Drug Substance Tech Transfer Lead to drive end-to-end introductions of new programs into our large-scale manufacturing operations. You will lead TT activities, partnering with internal stakeholders and customers to ensure timely, compliant introductions of clinical, PPQ, and commercial processes.

The role requires a Master’s degree in biochemical/chemical engineering and at least 8 years in pharma/biotech CMC or GMP manufacturing, with prior TT/CMC

Qualifications

• Master’s degree in Biochemical/Chemical Engineering or related field.
• 8+ years in pharma/biotech with CMC or GMP experience.
• Experience as TT Lead or CMC Project Manager.
• Strong GMP knowledge and cross‑functional collaboration.

Responsibilities

• Lead TT for new products into large-scale manufacturing.
• Develop and manage integrated TT project plans.
• Coordinate TT meetings and stakeholder engagement.
• Identify and mitigate risks; track milestones.
• Support CMC activities including regulatory inputs.
• Ensure GMP alignment throughout TT and manufacturing.
• Develop PPQ strategies with stakeholders.
• Execute CPV plans and process trending.
• Champion TT/PPQ best practices globally.

Skills

Tech Transfer

CMC Project Manager

Project management

GMP knowledge

Cross-functional collaboration

Education

MSc Biochemical Eng

Job description

FUJIFILM Biotechnologies Denmark is seeking a Drug Substance Tech Transfer Lead to drive end-to-end introductions of new programs into our large-scale manufacturing operations. You will lead TT activities, partnering with internal stakeholders and customers to ensure timely, compliant introductions of clinical, PPQ, and commercial processes.

The role requires a Master’s degree in biochemical/chemical engineering and at least 8 years in pharma/biotech CMC or GMP manufacturing, with prior TT/CMC