Drug Substance Tech Transfer Lead

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

For our site in Hillerød we are seeking a Drug Substance Tech Transfer (TT) Lead to drive end‑to‑end introductions of new programs into our large‑scale manufacturing operations.

Your New Role

As a Drug Substance Tech Transfer (TT) Lead at Fujifilm Biotechnologies Denmark (FLBD), you will play a pivotal role in bringing new programs and customers into our large‑scale manufacturing operations. In this fast-growing environment, you will lead end‑to‑end tech transfer activities for new products, partnering closely with internal stakeholders and customers to ensure timely, compliant, and successful introduction of clinical, PPQ, and commercial processes.

Main responsibilities

• Lead technology transfer for new products into large‑scale manufacturing, serving as the primary technical point of contact for internal teams and customers.
• Develop and manage integrated project plans aligned with program scope and cross‑functional priorities.
• Drive cross‑functional communication, coordinate regular TT meetings, and ensure transparent stakeholder engagement.
• Proactively identify, elevate, and mitigate risks; track milestones and deliverables to plan.
• Support CMC activities as required per program scope, including coordination and input for customer regulatory filings.
• Ensure alignment with filings and GMP requirements throughout tech transfer and routine manufacturing.
• Guide and support technical investigations
• Develop PPQ strategies tailored to each program in collaboration with internal stakeholders and customers; champion best practices for TT and PPQ globally.
• Execute and support process trending and Continued Process Verification (CPV) plans.
• Champion best practices for TT and PPQ globally outcomes.

Skills & Knowledge we hope you possess

• Master’s degree in Biochemical/Chemical Engineering or a relevant scientific field.
• Minimum 8 years of experience in the pharmaceutical or biotech industry in CMC process development and/or GMP manufacturing.
• Prior experience as a Tech Transfer Lead or CMC Project Manager.
• Strong understanding of biopharmaceutical manufacturing and GMP principles; experience in cell culture and/or protein purification is an advantage.
• Demonstrated project management excellence with the ability to evaluate complex issues and engage the right stakeholders.

We hope you are

• Strategic and detail‑oriented, able to balance speed of execution with quality and compliance.
• Strong communicator and facilitator with a collaborative, high‑performance mindset.
• Adept at risk management, problem‑solving, and decision‑making in a cross‑functional, customer‑facing environment.
• Comfortable working in a dynamic, fast‑paced setting with multiple priorities.

Your New Department & Team

Tech Transfer is a core function at FLBD. You will join a growing team of highly dedicated TT Leads with deep expertise in drug substance development and manufacturing
We manage and provide scientific leadership for new product introduction, PPQ and commercial processes in large scale manufacturing.

We work cross‑functionally with manufacturing, MSAT, quality, QC, regulatory, and our customers to maintain compliance and deliver on program goals. We also drive continuous improvement and help shape best practices and PPQ strategies for global deployment.

The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

This hybrid role is based at our site in Hillerød, Denmark.

FUJIFILM Biotechnologys is a global leader in biologics contract development and manufacturing (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle—from breakthrough cures to life‑saving vaccines.

Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.

Shape the future with us—your drive meets boundless opportunity here: https://fujifilmdiosynth.com/

FUJIFILM Biotechnologies Denmark (FLBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity, or any other protected class.

Location:

Hillerod