Product Owner, DP & FG Tech Transfers

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

Then you should apply to this interesting and challenging position as Product Owner and join the newly established DP& FG Tech Transfer Leads team (DP&FG TT leads).

Your New Role

You will assume ownership of Product Specific knowledge for our customers programs from Tech transfers to Life Cycle Management.

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

The scope will include collaboration 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.

Main Responsibilities

Within the scope of customer programs, you will act as Product expert which involves:

Interact with the commercial and program design organization in assessing Request for Proposals (RFP) and having customer meetings in connection with potential new partners and products

Drive together with the relevant SMEs the initial process designs and Q&A sessions with customer for clarifying product mfg. process options

Leading, preparing and owning product risk assessment, gap assessment, control strategy, product CQA and CPP assessment

Own engineering run & PPQ protocols and reports

Lifecycle responsible for product after completion of Tech Transfer (CPV, continuous improvements, APQR etc.)

Provide support or drive relevant CAPAs to resolve and evaluate product impact from mfg. OOS and non-compliance events the mfg. organization cannot handle.

During interactions with Health Authorities (Audits, inspections, Q&As, represents Fujifilm Biotechnologies for product specific requests)

Participates in relevant conferences, industry forums and trade fairs for competence development and network building

Skills & Knowledge

Experience from the pharmaceutical industry working in a GMP environment, incl. experience with pharmaceutical manufacturing equipment.

Solid understanding of drug product manufacturing and/or C.M.C

Experience in Regulatory documentation authoring

Strong communication skills in English (spoken and written).

Self-drive, proactivity and experience with managing complex assignments.

Solid experience from a similar role (preferred)

Your New Team & Department

DP& FG Tech Transfer Leads team contains DP and FG process and technology scientists/specialists. 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 Associate Director Behrouz Seifi +45 41 70 35 52 for further details.

FUJIFILM is a global leader in biologics contract development and manufacturing Organization (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

FUJIFILM Biotechnologies Denmark 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.

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