Scientist(s) with experience in raw materials for Drug Product manufacturing, Hillerød, Denmark (JR1865)

FUJIFILM Diosynth Biotechnologies have begun its large-scale expansion project in Hillerød.

We are progressing on the construction of our world class Drug Product Filling Facility and establishing a new team in the QC Raw Materials department to support this new area.

We are currently looking for several experienced scientists for the newly established team, one of three teams in QC Raw Materials (QC RM).

QC RM is a dynamic department responsible for the readiness of all raw materials (RM) for production, at the manufacturing site in Hillerød. The department consists of two teams handling sampling, testing, release, and tech. transfer of raw materials for our current drug substance manufacturing. The new team will have same responsibilities with the focus on raw materials for drug product manufacturing (DPM).

The job

You will be part of the QC RM DP team, that will ensure raw material readiness for the DPM. There will be an establishing period while facilities are being build and until it is ready for operation. You will in this period build the processes and structure needed together with your new colleagues, while ensuring that the agreed timelines for released RM are meet. As a joint team you will define the whole setup and future system for handling raw materials to DPM. When facilities are operational the team’s focus will change towards more daily operation and customer centricity.

Primary tasks will be:

• Develop and write SOPs for raw materials
• Prepare RM specifications and justifications for primary packaging materials, disposables and raw materials used in the manufacturing processes and devices to be used with the product
• Approval of analytical test results of raw material samples in LIMS and/or from external partners (CLOs)
• Representation of QC RM in Tech. Transfer projects and interactions with customers
• Focus on continuous improvements to all our processes and challenge the status quo

Professional qualifications

You hold a M. Sc. degree within e.g., Chemical Engineering, Biochemistry, Biotechnology or Pharmacy. You bring solid experience from a similar role and/or scientific experience, from e.g., research within the surface chemistry.

You have expert knowledge and understanding of the technical areas of RM requirements for drug product manufacturing. Experience with the different types of RM (liquid, disposables, primary packaging) combined with knowledge of guidelines and international standards, from the pharmaceutical industry is a clear advantage.

Furthermore, it will be an extra benefit if you have experience with external CLOs and onboarding of new materials.

Besides you are fluent in English, both spoken and written.

Personal qualifications

• You hold strong analytical skills and are not afraid to challenge internal and external partners, and you master the overview of the process from end to end.
• You can plan your day in a structural way and enjoy working in a team where there is room for a scientific discussion with a smile and a positive atmosphere.
• You thrive with cooperating with various departments and stakeholders and enjoy getting involved. Working in a busy department and a continuously changing environment is appealing to you.

We love people with “Genki”, which is one of our four values, and is Japanese for passion, energy, and drive. We believe in teamwork, a high degree of delegation, giving responsibility to those closest to the work. We believe in people!

What can we offer (#BestPlaceToWork)

The culture at FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is the most important if you ask our employees.

We offer:

• An exciting journey on a fast-growing commercial pharma site with lots of development opportunities
• An attractive salary package including health insurance, health check, fitness center and more
• Dedicated colleagues with a great team, department, and site spirit

Application

Please apply online in the HR system:

https://fujifilmdiosynth.wd3.myworkdayjobs.com/da-DK/External/job/Scientist-s--with-experience-in-raw-materials-for-Drug-Product-manufacturing_JR1865

Applications received in other ways will not be considered.

We will screen candidates and call in for interviews on a continuous basis and will close the position(s) as soon as the right candidate(s) is identified.

If you need more information

Please do not hesitate to contact Mette Honoré, Head of QC Raw Materials +45 41 94 99 71 or [email protected]

About FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies is 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 site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.

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.

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.

www.fujifilmdiosynth.com

Kilde: Jobnet.dk