GMP Supporter for our Drug Substance Manufacturing Documentation team

Do you have the flair for compliance and can handle many stakeholders? Are you looking for a more administrative position where you can take on responsibility?

Then a job in FUJIFILM Biotechnologies (FLBD) might be something for you.

We are a worldwide Contract Development and Manufacturing Organization (CDMO) with sites in the US, UK and Denmark. In Hillerød we are currently around 2000 employees working with every aspect of biotech and pharmaceutical production.

About the position

We have an opening for an Administrative Coordinator responsible for the following tasks:

Coordinate and manage a variety of documents, including BPRs, SLRs, logbooks, and handbooks for DSM.

Issue Documents and labels for DSM.

Review and ensure the accuracy of BPRs and logbooks.

Develop and maintain records and procedures by gathering necessary information from stakeholders to supply manufacturing with compliant documents.

Ensure timely closure of action items to for consistent production execution.

Support continuous improvement initiatives within the department and assist in stakeholder improvement projects.

Due to the tasks in the team, onsite presence is essential.

Qualifications

We are seeking individuals who are responsible, detail-oriented, and eager for professional growth. You should be comfortable working independently, collaboratively, and managing multiple stakeholders effectively.

2-5 years of industry experience with cGMP and pharmaceutical manufacturing is preferred.

A Bachelor’s degree in engineering, science, pharmacy, or a related field is desirable.

Understanding of Cell Culture and Purification operations.

Fluency in English is required in our international work environment.

About the department

In the department Drug Substance Manufacturing (DSM) Support we are responsible for supporting manufacturing operations with project management and compliance of procedures and documentation. Manufacturing Support consist of approx. 100 employees.

In the DSM Documentation team, we provide procedural support to GMP manufacturing and ensure compliance and document release activities in a timely manner. We create and maintain the document package for Drug Substance Manufacturing and perform procedural changes as well as assessing impact of events.

At FDBD we care about developing our employees. When you start working with us, you are not just starting a new job. It is important that you can work individually as well as in a team and it is important that you take responsibility for your own and your team's continuous development. As an employee in DSM Support, you will be thoroughly trained, we will set new realistic goals so that you continue your development and so that we support Fujifilm’s production the best possible way.

Your application

If your qualifications meet our requirements, and we have sparked your interest in joining us, please apply as soon as possible. We will process the applications as the arrive.

For questions or doubts, please reach out to Manager in Manufacturing Support Micha Berner by SMS +45 25662928.

Working at FUJIFILM Biotechnologies

We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth, we also offer access to fitness and an attractive canteen.

FUJIFILM 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 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.

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 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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