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Scientist for Analytical Technology

The FUJIFILM Diosynth Biotechnologies, Denmark Analytical Technology group is seeking a skilled Scientist to fill an exciting role to lead and execute transfer of methods to and from the Hillerød site. You will liaise with various external collaborators, QC and QA groups to ensure training needs, internal procedures, and protocols are met as well as ensuring compliance to the pharmacopoeias and ICH guidelines. 

 

Primary Responsibilities

  • Drive change controls and perform assessments of raw materials used in production, pharmaceutical raw materials (excipients), active pharmaceutical ingredients (API), and pharmaceutical drug substance (DS) and drug product (DP)
  • Author and review justification specification report for raw materials
  • Author and review verification/qualification protocols and reports
  • Author and review method transfer protocols and reports
  • Author and review method validation protocols and reports
  • Work in conjunction with QC testing teams and contract laboratory organisations (CLOs) during method transfers of validated methods and compendial methods

 

Qualifications / Skills

  • Master of Science within Pharmaceutical Sciences, Biochemistry, Protein Chemistry, or Biology
  • Solid understanding of GMP/GLP guidelines with several years of experience from the biotech or pharmaceutical industry
  • Broad background in analytical methods as well as the capability of being able to absorb and utilise new knowledge quickly
  • Knowledge of ICH guidelines is an advantage
  • Experience with method transfer and validation
  • Experience in the Unites States Pharmacopoeia and the European Pharmacopoeia
  • Experience in change controls
  • Excellent oral and written communication skills
  • Have a safety-first mindset where you proactively keep an eye out for safety issues

Please apply as soon as possible as we screen applications on an ongoing basis.

APPLY HERE

Working at FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organisation (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 re-imagining healthcare’s potential. We work across the entire life-cycle 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

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.


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