Tech Transfer Lead

Your New Role

The Technology Transfer (TT) Lead is a critical role within FDBD as the company is growing fast and we introduce new programs and customers continuously.

You will lead TT activities for new products into large scale manufacturing facility and coordinate and lead regular meetings for TT programs with key internal stakeholders and customers.

Main Responsibilities

• Develop project plans in alignment with all relevant functions within the organization and in alignment with program scope
• Escalation of risks and tracking of milestone progress.
• Ensure cross functional communication to key stakeholders.
• Support CMC activities for development and manufacturing as required per the program including coordination and input to customer regulatory filings.
• Support the technical team to investigate any project challenges with necessary risk assessment tools and techniques.
• Develop PPQ strategies specific for each program in collaboration with internal stakeholders and customers.
• Execute on and support process trending and continued process verification plans.
• Review and document process performance and product health through process trending, monitoring, and supporting annual product reviews
• Point of Contact to customer and internal regulatory team for technical aspects of the process/program
• Identification of continuous improvements opportunities
• Support best practices for TT and PPQ strategies globally.
  
  
  

Skills & Knowledge We Hope You Possess

• You have a master’s degree in Biochemical/Chemical Engineering or scientific relevant field
• A minimum of 10 years pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing, preferably in a position as Tech Transfer Lead or CMC Project Manager.
• You can demonstrate successful project management skills and you have a solid understanding of Biopharmaceutical manufacturing and GMP (Experience in either Cell Culture and/or Protein Purification is an advantage).
• You can evaluate complex matters and identify key stakeholders.
  
  
  

We hope you are

Able to pay attention to both the details and the bigger picture. You are a high performing team player, ambitious on behalf of yourself and the company, and that you can balance between speed of execution and quality of work.

Your New Department & Team

TT is a core function within FDBD. We are a growing team of 6 highly experienced and dedicated TT Leads with background within pharmaceutical development and manufacturing of DS.

We provide scientific leadership to support new product introduction as well as clinical, PPQ and commercial processes in large scale manufacturing.

The TT leads manage the TT process and progress working cross-functionally and with our customers, supporting CMC activities for our customers, and maintaining compliance to filings.

In addition, we continuously strive to identify opportunities to improve systems and practices and direction to our manufacturing group as well as technical development teams and our customers.

Fujifilm Diosynth Biotechnologies is expanding globally with facilities for large scale Cell Culture manufacturing being built in both Denmark and US. The development of best practices and PPQ strategies to be deployed globally extends the impact of this role beyond the site.

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.

Questions

Please do not hesitate to reach out if you have any questions to Director, Technology Transfer Eugenia Pagans Lista +45 25662990

We urge you to send an updated CV and cover letter as soon as possible. We will continuously invite relevant candidates for job interviews and will close the position as soon as we have found the right candidate.

The position is placed in Hillerød.