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Fujifilm

Global precision manufacturer for healthcare

Drug Substance Technology Transfer Lead

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeHillerød, DenmarkNo salary listed

About the Job

Requirements

  • A Master's degree in Biochemical or Chemical Engineering, or a relevant scientific field.
  • At least 8 years of experience in the pharmaceutical or biotech industry in CMC process development and/or GMP manufacturing.
  • Prior experience as a Technology Transfer Lead or CMC Project Manager.
  • A strong understanding of biopharmaceutical manufacturing and GMP principles.
  • Demonstrated project management ability, including evaluating complex issues and engaging the appropriate stakeholders.
  • Ability to balance speed of execution with quality and compliance.
  • Ability to manage risks, solve problems, and make decisions in a cross-functional, customer-facing environment.
  • Ability to work in a dynamic, fast-paced setting with multiple priorities.

Responsibilities

  • Lead technology transfer for new products into large-scale manufacturing and serve 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 technology transfer meetings, and ensure transparent stakeholder engagement.
  • Identify, escalate, and mitigate risks; track milestones and deliverables against plan.
  • Support CMC activities as required by program scope, including coordinating and providing input for customer regulatory filings.
  • Ensure alignment with filings and GMP requirements throughout technology transfer and routine manufacturing.
  • Guide and support technical investigations.
  • Develop PPQ strategies for each program in collaboration with internal stakeholders and customers, and champion technology transfer and PPQ best practices globally.
  • Execute and support process trending and Continued Process Verification plans.
  • Provide scientific leadership for new product introduction, PPQ, and commercial processes in large-scale manufacturing.
  • Work cross-functionally with manufacturing, MSAT, quality, QC, regulatory teams, and customers to maintain compliance and deliver program goals.
  • Drive continuous improvement and help shape best practices and PPQ strategies for global deployment.

Desired Qualifications

  • Experience in cell culture and/or protein purification is an advantage.
  • Strong communication and facilitation ability in a collaborative, high-performance setting.

About the Company

Fujifilm

Global precision manufacturer for healthcare

Fujifilm is the main operating and manufacturing arm of the Fujifilm group, turning precision chemistry, nanotechnology, and optical engineering from the film era into products for deep tech and life sciences. It runs Bio CDMO facilities that manufacture complex biopharmaceuticals and vaccines, and its materials division makes photoresists and chemical slurries essential to semiconductor and display production. In healthcare, it develops AI-powered imaging devices, endoscopes, and ultrasound systems, while also serving consumers with INSTAX instant photos and X-Series cameras. Its goal is to translate core technical capabilities into reliable, market-ready products across healthcare, electronics materials, and imaging, maintaining leadership in precision manufacturing and applied science.

Company size
501-1,000
Company stage
IPO
Headquarters
Tokyo, Japan
Founded
1934

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