Drug Product Technology Transfer (TT) lead

Would you like to contribute to timely and vital Drug Product Tech Transfers for the Formulation, Fill/Finish and Visual Inspection Processes? And do you thrive working in cooperation with scientists / SMEs?

Then we hope you are our new proactive and skilled colleague to join the Drug Product Manufacturing Sciences and Technology (MSAT DP) team!

Your New Role
You will be handling complex Drug Product Technology Transfers. You will coordinate the activities and work packages and work with the relevant work package’ owners and specialists to execute robust and timely Tech Transfers.

The scope will include supporting and working with our US site based in Holly Springs North Carolina. The US site will come online in 2026 and between that and the Danish Site in Hillerød several exciting Tech Transfer projects are foreseen in the future.

There will be close collaboration with the relevant partner representatives and well as the Fujifilm Program Managers (who manages the business side of the relation).

Main Responsibilities

• Acting as overall Tech Transfer Lead on clinical and commercial Drug Product programs being established in Hillerød. Being primary point of contact with the customers Science and Technology organization.
• Product owner for the tech transferred products in terms of MSAT matters, CQAs, CPPs. Responsible for resolving and evaluating product impact from mfg. OOS and non-compliance events the mfg. organization cannot handle.
• Participates as relevant with the commercial and program design organization in assessing RFPs and having customer meetings in connection with potential new partners and products
• Drive together with the relevant SMEs the initial process designs and QandA sessions with customer for clarifying product mfg. process options and need for CAPEX
• supports proposal creation and reviews proposals for MSAT relevant aspects around the proposed product mfg. process
• Coordinates between individual work packages in the Tech Transfers and ensuring overall timely progress through the phases of the transfer up until completed PPQs and handover to the Mfg. Organization
• MSAT primary point of contact to Program Manager for established programs with specific customers. Manages communication of performance of the mfg. process for the specific products in a customer program. Coordinates / clarifies internally for process and technology related matters from the customer.
• Provides support towards operational readiness for the DP processes, including support for training, procedures etc.
• Participates in relevant conferences, industry forums and trade fairs for competence development and network building

Skills & Knowledge, we hope you possess:

• -Experience from the pharmaceutical industry working in a GMP environment, incl. experience with pharmaceutical manufacturing equipment.
• You will either be able to step directly into such a position or over time you will develop into the role by taking increasingly complex tasks in connection with Tech Transfers.
• We welcome applications from newly graduated that bring a curiosity and mindset of developing within and mastering complex processes and technologies.
• Interest and bandwidth for continually learning about new technologies, processes and products.
• Strong communication skills in English (spoken and written).
• Profound analytic skill
• Self-drive, proactivity and experience with managing complex assignments.

Your New Team & Department
MSAT DP contains the drug product process and technology scientists/specialist as well as the tech transfer leads and the CQV specialists. We are growing from currently 12 colleagues to more than 15 over the coming year as we get closer to clinical and commercial drug product manufacturing operations.

We are team players, entrepreneurs, and people who both like details and taking greater responsibility beyond our scope of work. The work environment is international and informal. We keep a high pace and focus on a vital work 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.

Application
Has this sparked your interest, then please upload your CV and cover letter as soon as possible as we will screen candidates on a continuous basis and call in for interviews. Please do not hesitate to reach out to Director Henrik Hermann +45 25 66 30 55 for further details.

The Company
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.

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.

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, 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