We are looking for one highly organized, detail-oriented stability specialist with a quality mindset, to be responsible for managing stability studies and supporting procedures and projects.
About FUJIFILM Diosynth Biotechnologies and our Quality Department
FUJIFILM Diosynth Biotechnologies is a world leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry – from pre-clinical investigations to commercial GMP production. Our overall mission is to “Advancing Tomorrow’s Medicines” and we like to invite you to be part of that journey.
You will be part of a Global Quality organization that is local anchored at the site in Hillerød. The local quality organization consists of approximately 300 employees divided into various QA, QC and Program Quality teams. In Quality we strive to help and support each other across teams not only to reach our goals but also to support a high level of collaboration and possibilities for personal development. The pillar in our Quality department is our employees – our success is only possible due to competent and dedicated colleagues, who wants to make a difference for Quality, our site, our customers, and patients all over the globe. As a leading CDMO company we, in Quality, are obligated to continuously improve our way of working creating a dynamic and inspiring environment with huge individual co-decision making due to our flat organizational structure.
The culture at FUJIFILM Denmark (FDBD) is key if you ask our employees and besides a competitive salary and bonus package, we offer health insurance, massage and physiotherapy, health check, fitness center, possibility to work from home and a mobile barista coffee van. FDBD also has a canteen arrangement incl. Friday brunch and monthly afternoon cake, just as we have a “bell ringing” tradition when reaching important milestones.
About the Team
Program Quality is a global quality organization (FDB network) that consists of approximately 24 employees divided into 4 teams, where Stability is one of them. Stability currently consists of 3 dedicated employees but will be expanding due to expansion of the business. The team participates in internal and external meetings together with relevant stakeholders during the technology transfer process and commercial production. The team also participates in audits and inspections performed by regulatory authorities and customers. The overall responsibility of the stability program at FDBD lies in the Stability team.
About the Position
This role demands the candidate to operate independently and as part of a team with internal as well as external partners. This position requires a high degree of understanding within the stability area as well as process insight to drive, facilitate, and manage stakeholders across the entire business.
In this position you can expect to build-up a strong insight to our business, and a strong network both internally, globally and with various customers.
You will work closely with internal stakeholders in many different departments to ensure high performance for every customer. You will be part of the Program Quality Organization, which includes Program Quality Managers, Data Management and Stability. We work in a busy and dynamic environment where we support biologics Drug Substance (DS) production as well as the global release of commercial products (DS/DP/FG) for our global network of clients.
Your primary tasks will be but not limited to:
- Author and maintain stability protocols and specifications
- Create Change Controls within the stability area
- Build and maintain stability studies in LIMS
- Create final stability data reports to customers
- Be responsible for stability chambers
- Create and maintain contracts covering stability and additional QC services
- Support QC Sample Handling and Shipping documentation
- Drive projects within the team.
- Participate as a Subject Matter Expert in customer and regulatory audits
- Participate/facilitate meetings globally and with customers
Professional and Personal Qualifications:
- Degree in Natural Science (For instance Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences) or with similar experience
- Preferably minimum 5 years relevant experience from the pharmaceutical industry
- You have experience with / knowledge of stability requirements
- Knowledge of GMP Quality Systems with a high quality mindset.
- As a person, you are organized with an attention to detail, but are still able to keep an overview.
- You have an excellent verbal and writing communication skills in English.
- You like the combination of driving larger projects within the team, as well as performing smaller tasks related to daily business
- You have an ability to work independently and are self-driven
- You are a team player
- You thrive in a changing environment
At FDBD we put people first and we always look for candidates with the right combination of personality and skills. FUJIFILM Diosynth Biotechnologies will, as any other modern company, ask our employees for agility and flexibility from time to time but we always make sure to have a controlled work-life balance. We are many different nationalities and personalities at FDBD and for us to succeed we all need to focus on communication, take responsibility, organize, and execute on various tasks, solve problems, and display great interpersonal skills.
Application
Has this sparked your interest? Then we urge you to send an updated CV and cover letter as soon as possible. We will continuously invite relevant candidates for job interviews and will close the position as soon as we have found the right candidate.
In case you have any questions, please do not hesitate to contact Associate Manager, Maria Myntman +45 40382416.
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.
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.
What We Do
For over 30 years, FUJIFILM Diosynth Biotechnology’s mission has been advancing tomorrow’s medicine. As a CDMO, we work in partnership with the most innovative biopharma and biotech companies across the world who are reimagining healthcare’s potential. We help to accelerate their progress, expand their capabilities, streamline their processes, and strengthen their innovation. So when our customers’ potential cures, vaccines, biologics, and accomplishments make strides – or even become new realities for patients – we know our work, our manufacturing expertise, and our partnership helped make it happen.
FDB isn’t simply a workplace. It’s a place of passion – a place of what we call Genki. A place where diverse perspectives and people come to life. Where opportunity for growth has no end. Where passion is followed, discovered, and nurtured. Where the energy is undeniable, enthusiasm is pervasive, and drive is infectious. All of our global locations burst with curiosity, inspiration, and extraordinary purpose.
So as we continue to grow our teams, our global locations, and our capabilities, Genki will always be our cultural tie. That’s why we’re always looking for passionate, mission-driven people who want to commit their life’s work to enabling better outcomes for patients and their families.
For a full listing of jobs that will propel, inspire, and fulfill you, please visit: fujifilmdiosynth.com/careers/
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