Scientist or Senior Technician for Dose Formulation Analysis - 12-months maternity cover

Are you a skilled coordinator who thrive in multidisciplinary team environments consistently meeting timelines and achieving deadlines? Do you know your way around HPLC analyses or validations and have experience working within a regulated environment? If so, then the Dose Formulation Analysis (DFA) team is eager to welcome you onboard in this 12-months maternity cover position with the possibility of permanent employment! The position In the DFA team, we are responsible for outsourcing DFA activities to support Good Laboratory Practice (GLP) compliant non-clinical safety pharmacology and toxicology studies across all developing projects in the [xxxxx] pipeline. We also coordinate and outsource formulation, stability, and method validation studies by HPLC to CROs. We act as monitors according to the Good Laboratory Practice (GLP) guidelines and our primary responsibility is to ensure that all work is conducted to both the correct scientific level and in regulatory compliance. Without DFA, no non-clinical studies can be performed, so our job is essential to progressing the projects! Our role is to coordinate studies and provide our scientific knowledge to support the formulation and analytical work at our contract research organizations (CROs), rather than doing laboratory work ourselves. We are in daily contact with many internal and external stakeholders to collect knowledge and documentation on project timelines, technical data, method transfer details etc. to ensure support of the ongoing non-clinical studies. Based on this information we communicate with our CROs and support their work with both HPLC quantification and HPLC method validation studies ensuring timely delivery of data. Your main responsibilities will include, but not limited to:

Contracting DFA activities

Communicating with CROs and our internal stakeholders regarding scientific knowledge and study conduct

Coordinating study timelines and deliverables e.g. collecting relevant documents from internal stakeholders, shipment of compound and sharing technical data with CROs

Reviewing study plans and reports from CROs

Depending on your background and previous experience, you will receive the training needed to support the responsibilities of the team e.g. training in the GLP regulations and validation guidelines. Despite being an outsourcing role, the job includes extensive interaction with internal stakeholders in CMC and Global Discovery and Development Sciences (GDDS) and other team members, hence physical presence in Måløv is required. Qualifications You have an educational background in life sciences, laboratory technician or similar. It is a significant advantage that you have experience in working with HPLC-UV analytical methods as well as experience in coordinating and organising with internal and/or external stakeholders in the scientific field. Preferably you have the following qualifications:

Experience from working within a regulated environment, e.g., a GxP or ISO environment

Experience with analysis of formulated pharmaceuticals (drug prodrugs)

Experience in collaborating with external laboratories (CRO or CMO)

On a personal level, great communication and stakeholder management skill. You are proactive and are capable of working in a multidisciplinary environment and meeting timelines. Furthermore, you have strong written and oral communication skills in English. We welcome candidates with the right skills and relevant background, even if they have less experience. About the department The functional area of Safety Sciences & Imaging, department of Safety Pharmacology & Early Toxicology is responsible for the DFA team in collaboration with the toxicologists and safety pharmacologists to support non-clinical studies across the entire project portfolio at [xxxxx] A/S. The team supporting DFA currently consists of 3 employees. Working at [xxxxx] At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Peter Helding Kvist, Director on +[xxxxx]or Mie Højer Larsen, Specialist on +[xxxxx]. Deadline 30 June 2024. Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified. 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. To ensure an efficient 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.