Drug Product Tech Transfer Lead

Hillerød, Hovedstaden
Permanent
Fuldtid

13 dage siden

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 you should apply and join our newly established DP& FG Tech Transfer Leads team (DP&FG TT leads)Your New RoleYou 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.
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
Participates as relevant with the commercial and program design organization in assessing request for proposals and having customer meetings in connection with potential new partners and products
Drive together with the relevant SMEs the initial process designs and Q and A sessions with customer for clarifying product mfg. process options and need for CAPEX
Supports proposal creation and reviews proposals for Tech Transfer 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
Tech Transfer lead 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.
Provide support to resolve and evaluate product impact from mfg. OOS and non-compliance events the mfg. organization cannot handle.
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

Your Skills & Talent

Experience from the pharmaceutical industry working in a GMP environment
You can demonstrate successful project management skills, preferably in a position as Tech Transfer Lead or CMC Project Manager
Understanding of drug product manufacturing and/or C.M.C
Experience in Regulatory documentation authoring
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 & DepartmentDP& 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.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 wellApplicationHas 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 Associated Director Behrouz Seifi +45 41 70 35 52 for further details.FUJIFILM Biotechnologies 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 hereFUJIFILM 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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