Tech Transfer Lead

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.

So if you fit the role, we hope you will join us!

Your New Role
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.

We are 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

Application
We urge you to send an updated CV and cover letter as soon as possible. We 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.

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

Our site in Hillerød, Denmark, brings together expertise, capabilities, and technologies to manufacture advanced biologics. The large-scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.

We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) 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 identify or any other protected class.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid

Location: FDBD Hillerod