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Specialist to Drug Product Manufacturing

Are you a Manufacturing Specialist with an entrepreneurial mindset? Are you a can-do team player, who likes to take responsibility beyond your scope of work and still pay attention to detail?
Then you could be our new colleague in the Drug Product Manufacturing Department, Filling Team at our future, state of the art Drug Product facility in Hillerød!
Your New Role
We are currently building our new world class Drug Product Filling facility, including qualification of equipment for the entire facility, so you will join a newly established and highly skilled team within the Drug Product Operations.
You will participate in setting up the manufacturing operating structure, manufacturing processes, and contribute to preparing the extensive documentation package of operational character for the new facility together with the Compliance team and the North Star Drug Product Project, and afterwards transitioning into a more supporting role to the production.
Tasks Within the Department
  • Develop the operational documentation package (SOP’s and WI’s)
  • Develop Electronic master batch records and include new programs
  • Assist in execution of process qualification and validation, FMEA and Tech transfer activities as required
  • First line support for operation
  • Lead for events and deviations
  • Continuous Improvements on e.g. flows of personnel, materials and equipment
  • Drug Product Operation SME on Projects
  • Participate in Tech Transfer projects and implement new programs in operation
  • Identification and implementation of corrective and preventive actions (CAPAs) to prevent re-occurrence and improve compliance
  • Conduct Training of colleagues
  • Create equipment recipes
  • Create and maintain electronic logbooks in Drug Product Operations
  • Documentation review and follow up
Your Talent, Skills & Knowledge
  • You have a few years of GMP experience from the Pharmaceutical or Biotech industry.
  • Preferable you have experience within Filling.
  • You can work independently on compliance related tasks, events, and optimization projects.
  • You are an expert in stakeholder management, and are motivated by the interface between QA, Process Science and Manufacturing.
  • You understand and can execute within regulatory requirements.
  • You have a high level of technical writing skills and excellent communication skills in English and Danish (spoken and written).
  • You have a Bachelor or master’s degree within Pharmaceutical Sciences, Process Engineering, or similar area.
You are curious by nature, and you meet and greet people with a smile. You work with a humility and respect for the people around you. You are independent, pragmatic, and able to prioritize tasks to meet defined timelines. You work in a structured manner with a quality mind-set and enjoy working independently and proactively in a dynamic environment.
The Department
The Drug Product Manufacturing department will consist of approx. 60 dedicated and enthusiastic employees, when the filling suite is ready for production. DPM will contain several teams covering Wash & Sterilization, Formulation, Filling, Inspection and Compliance. The common denominator of the teams is the acknowledgement and development of every employee and the diversity of the employees who have different experiences and educational backgrounds but collaborate closely on getting our medicine safely and quickly on the market.
It’s our ambition to make the Drug Product facility a state of the art, with an automated isolator filling line and inspection line. All process documentation and EM samples are being executed as per relevant operating procedures.
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 in English as soon as possible, as we screen candidates on a continuous basis and call in for interviews. If you have any questions, do not hesitate to reach out to Manager Sara Tiedemann +45 41703542.
Please accept some delayed response time due to vacations. We hope you have a great Summer.
FUJIFILM Diosynth Biotechnologies is an industry-leading biologics Contract Development and Manufacturing Organization (CDMO) with global locations including one in Hillerød, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies. Among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems.
Our manufacturing site in Hillerød, Denmark, is a large-scale manufacturing facility with a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use.
At FUJIFILM Diosynth Biotechnologies, you will gain hands-on experience in an industry-leading biologics Contract Development and Manufacturing Organization. We aim to foster a collaborative, innovative, diverse, and rewarding environment, where it is possible for employees to develop personally and learn. They can pursue their fullest potential as individual contributors and team members. Customer trust, digitalization, best place to work and expansion of capacity and end-to-end capabilities are cornerstones of the Fujifilm Diosynth Biotechnologies strategy in Hillerød, DK.
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.
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CEO of Fujifilm Diosynth Biotechnologies
Fujifilm Diosynth Biotechnologies CEO photo
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At FUJIFILM Diosynth Biotechnologies our mission is to become the leading and most trusted global CDMO in the industry, and our purpose is to become Partners for Life, Advancing Tomorrow’s Medicine

22 jobs
SECTOR
Biotech & Pharmaceuticals
TEAM SIZE
1001-5000
LOCATION
Hybrid
DATE POSTED
August 3, 2023

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