• Job Description

  Req#: JR2977

  Maternity Cover, QA Associate for Drug Substance

  Are you a Quality Assurance specialist or newly educated, eager to join a fast-growing CDMO? Apply for this position where you will be an important part of developing and ensuring our quality aspiration.

  Follow Your Genki to FUJIFILM Diosynth Biotechnologies

  The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.

  Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics.

  About the Role

  You will take on a role as a QA partner for activities related to Drug Substance Manufacturing activities, daily operations and optimization projects.

  About the Department/Team

  You will be part of the QA DS Upstream team.

  Currently the team consists of 14 dedicated Quality Specialists that covers the Drug Substance Manufacturing operation and the many tasks that goes along with that.

  It is a dynamic team in daily contact and in close collaboration with all internal stakeholders and QA colleagues in the department.

  Job Responsibilities

  Your primary tasks will be:

  • To perform batch review activities, ensuring the batch has been manufactured and tested in accordance with accordance with GMP regulations
  • To review and approve alarms from our alarm system, work orders from our maintenance system and bill of materials/parameters/ for our production needs
  • To help maintain the quality system based on the current GMP, Good Documentation Practices and regulatory requirements.
  • To adhere to the quality system and support the Drug Substance Manufacturing organization in appropriate handling of exceptions and change management
  • You will also support the quality assurance department with all relevant ad hoc quality tasks

  Qualifications

  We are looking for a candidate with the following background and skill sets:

  Professional qualifications

  • University degree in pharmacy, medicine, veterinary science, pharmaceutical chemistry and technology, chemistry, biology, or similar life science degree
  • Knowledge of GMP quality systems and legislation
  • High-Quality mind-set
  • Experience with data handling and technically savvy is considered an advantage

  Personal qualifications

  • A team player
  • Thrive in a changing, busy environment
  • Enjoy primarily working on-site
  • Service minded
  • Proactive in your approach
  • Able to work independently
  • Enjoy working with multiple stakeholders in a large organization

  Application

  Has this sparked your interest? Then we urge you to please upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis. Should you have any questions, please feel free to reach out to Manager in QA, Christina Schmidt at christina.schmidt1@fujifilm.com.

  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.

• About the company

  A global CDMO in pharmaceutical manufacturing providing process development and cGMP production in cell culture, microbial fermentation and gene therapies.

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