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Manufacturing Support Associate - Change Over

The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important—and we are looking for talented candidates to join us on our exciting expansion journey. We’re growing our locations, our capabilities, our teams and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.
We are looking for a talented Manufacturing Supporter for the Drug Substance Production to join the Drug Substance (DS) Documentation and Support Department in Hillerød.
Who You’ll be Working With, and What You’ll Be Doing:
The Campaign Lifecycle Management (CLM) Team is a small but mighty subteam within the Support Department. We support a variety of tasks towards the shop floor, with the main areas covered by the CLM Team being:
  • Changeover of equipment between production campaigns
  • Scheduling and preparation of Chromatography Column activities
  • Coordination of daily production tasks in our manufacturing scheduling system
  • Change Control Coordination and Campaign Readiness preparation
The team currently consists of 12 people, with a great sense of humor and a high willingness to support where needed. Being that we are a small team, we need you to be self-driven and able to prioritize tasks depending on urgency.

Your primary tasks will include,
  • Preparing records for execution of changeover and column pack between campaigns
  • Being the point of contact to coordinate and ensure timely execution of changeover between Manufacturing, Engineering, Quality Control and Quality Assurance.
  • Planning and ensuring execution of Column Pack for upcoming campaigns including preparation and review of documentation and sample results.

Additionally you will
  • Collaborate closely with the Manufacturing Shop Floor
  • Work with Tech Transfer and DSM Expansion teams to include best practices to prepare for future expansions.
  • Develop skills to act as a Subject Matter Expert in e.g. Regulatory Audits or assessment of changes
  • Collaborate with other support functions to identify opportunities to reduce equipment down time

Skills and Knowledge
  • A Bachelors or a Masters Degree in Life Science or Engineering or similar field.
  • 2-5 years of work experience with GMP or other regulated industries is an asset, but not necessary
  • We are hiring for attitude, so we are looking for a candidate who has a lot of drive and an interest in working under GMP.
  • You are proactive, responsible, organized, and able to take ownership of tasks.
In return we can offer you to broaden your process knowledge and to improve your problem-solving skills. You will have influence on your position and the future development of the role according to our business strategy. Additionally, you will be part of the future organisation needed for the 11 Billion DKK manufacturing expansion currently being undertaken at the Hillerød site.
Your application
If you are as excited as we are and believe this is the right opportunity for you, please submit your CV and motivation letter in English as soon as possible as we will have ongoing interviews.
For questions, please do not hesitate to contact Manufacturing Supervisor Micha Berner on +45 25 66 29 28 or on
micha.berner@fujifilm.com
About FUJIFILM Diosynth Biotechnologies
We are 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.
Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team. Learn more at https://fujifilmdiosynth.com/

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, 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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CEO of Fujifilm Diosynth Biotechnologies
Fujifilm Diosynth Biotechnologies CEO photo
Lars Petersen
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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

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DATE POSTED
June 9, 2023

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