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  • 02.03.2023
  • Øvrige
  • Gentofte

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Academic for Stability Team

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Are you interested in getting involved with Biopharm’s broad portfolio of products for treatment of haemophilia and growth hormone deficiency? We are looking for a skilled and motivated chemist in our stability team, experienced within GMP and the pharma-ceutical industry. The Position You will be part of the stability team, which consists of 5 chemists and 13 technicians. The team is responsible for handling stability studies, reference samples and customer complaints. Your responsibility will be to write and review documentation defining shelf-life stability studies for both new and marketed products, including regulatory submission documents to health authorities. All of this will be conducted in coopera-tion with colleagues in Manufacturing Development, CMC, Quality Control (QC), Quality Assurance (QA) and Production and Regulatory Affairs (RA). Other tasks will be to handle change requests and deviations in accordance with our quality system. You will be driving root cause analysis and trouble-shooting sessions and support the team and department with your expertise and knowledge. You will also be identifying, developing, and executing optimisations of daily routines and gen-eral processes. Qualifications To succeed in this role, we expect you to have:
  • An academic degree in Life Sciences or similar.
  • Experience as a chemist, pharmacist, engineer or similar. You may also be a new graduate, highly motivated to learn.
  • Experience working in accordance with cGMP and in the pharmaceutical industry is an advantage.
  • Knowledge about stability studies, GMP regulations, climate facilities and quali-fication will also be advantageous.
  • Full professional proficiency in both written and spoken Danish and English.
  • As a person, you are responsible, dedicated and have an open-minded approach. In addition, it should be natural for you to take the initiative and put yourself in play. You are good at creating an overview and have the courage to solve new types of tasks. You want to work with documentation in a structured way across both our department and in close collaboration with other areas (e.g. Regulatory Department (RA) or Quality Control (QC)). About the Department Our team is part of the BRD Quality Control area that is based in Gentofte, Hilleroed and Kalundborg. Here we are app. 270 colleagues who support the biotech production with a selection of chemical and microbiological analysis of product samples, crucial for always making sure the product is in high quality and ready for release to patients. We bring value to patients by delivering timely and reliable results that keeps production in control. We drive change by always looking for improvements and innovation within our processes - testing and implementing 4.0 technology to make the process even smoother and faster for the benefit of the patients. Working at BRD, [xxxxx] Biotech & Rare Disease (BRD) is part of [xxxxx] Product Supply, which is a global production network at the forefront of technology and in quality production of pharma-ceutical products. In BRD we are not only supplying all [xxxxx] products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for [xxxxx]. We are app. 2500 colleagues committed to drive change for people with serious chronic dis-eases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we are also stiving to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career? Contact For further information, please contact, Associate Manager, Malene Christensen +[xxxxx]. Deadline 19 March 2023. Applications will be screened on an ongoing basis, so you are encour-aged to apply as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. Also, to ensure an effi-cient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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