Formulation Process Lead /Work Package Owner

Tytuł pracy:

Formulation Process Lead /Work Package Owner

Firma

Fujifilm

Opis stanowiska

Would you like to take accountability for a critical manufacturing process in Drug Product and be at the forefront of technological innovation?And do you thrive in a dynamic C.D.M.O environment where excellence and growth are paramount?Then join us as our new Process Lead / Work Package Owner within our talented Drug Product Manufacturing Science And Technology Team (DP MSAT).Your New RoleYou will be our Process Owner /Work Package Owner (Technology SME) within Drug Product Manufacturing Science And Technology on the Thawing Formulation, Pooling / Mixing and Filtration Processes.You will drive/coordinate Tech transfer activities related to processes in scope within Tech Transfer programs. This includes acting as Process SME but also as technical project manager for processes in scope.Main tasks:

• Along with the Equipment responsible you will drive and provide inputs on creating processes and procedures towards having shortest mean time to repair (and getting it right first time) and longest Mean time between failure. Creating clear data driven structures to understand and prioritize on solving and eliminating equipment potential failure modes.
• Participate / Drive continuous Process improvement of the DP manufacturing processes.
• Along with the Responsible Engineer, being up to date with new technologies and equipment and drive feasibility studies.
• Be part or chair, cross functional process groups spanning Fujifilm manufacturing sites.
• For new programs/ Tech Transfers:

• Evaluation of feasibility, capacity and technology fit to existing platform.
• Evaluation of Product specific characterization and formulation activities
• Evaluation and update of Risk Management and GMP documentation related to processes in scope
• Develop and implement new technologies related to processes in scope.
• As Process Owner you will represent MSAT for interactions with Manufacturing, Engineering, Operations, Quality, QC, Projects Manager and Heath authorities.
• Function as second line support to Operation organization in complex and unforeseen process related GMP events. Leading troubleshooting teams and CAPAs.

Skills & Knowledge, we hope you possess

• Relevant Experience from the pharmaceutical industry working in a GMP environment, incl. experience with pharmaceutical manufacturing processes in scope.
• Strong communication skills in English (spoken and written).
• Excellent interpersonal skills
• Self-drive, proactivity and experience with managing complex assignments.
• Interest and bandwidth for continually learning about new technologies, processes, and products.

Your New Team & DepartmentYou will be part of the DP MSAT team, a large and diverse team of experienced multi-disciplinary experts.DP MSAT is composed of drug product process and technology scientists/specialist as well as, the CQV specialists, the DP development Lab analysts and a Risk Management specialist.We are growing from currently around 16 colleagues as we prepare for 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 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.ApplicationHas this sparked your interest? Then please send us your resume and a cover letter detailing your experience and why you are the perfect fit for this role as soon as possible, as we conduct interviews on an on-going basis. Please do not hesitate to reach out if you have any questions to Director Frédéric Osuch +45 20723569FUJIFILM Diosynth 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 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.

Oczekiwane wynagrodzenie

Lokalizacja

Hillerød, Hovedstaden

Data pracy

Thu, 10 Apr 2025 07:35:15 GMT

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