Development Laboratory Manager - Pharmaceutical Product Development
Are you interested in an exciting new challenge as Laboratory Manager for our Development Department?
Do you have the experience, drive and focus on drug product development, team leadership and quality to help us realize our growth ambitions for the development of new pharmaceutical products? If so, then please read on.
Who are we?
Orifarm Manufacturing Viminco (Orifarm MV), located in Skælskør, Denmark, is part of the Orifarm Group, one of the Nordic region's largest pharmaceutical companies, and we develop and manufacture pharmaceutical products for Orifarm Generics’ portfolio and a number of well-consolidated companies in the Nordic region. We have experienced strong growth over the last few years and Orifarm's vision is to further strengthen our capabilities.
We have recently opened a purpose-built development laboratory and expect our growth to continue in the coming years. This is a particularly exciting time as we begin to explore opportunities for collaboration with new manufacturing sites recently acquired by Orifarm.
The Development Department comprises 24 dedicated colleagues and is responsible for the development of generic drugs, maintenance of existing ones, and transfer of newly-acquired products into our commercial facility. We handle the entire development process including formulation development, analytical method development and validation, compilation of quality documentation used in registration of new products and technology transfer to commercial QC.
Your primary responsibility will be to manage the analytical laboratory and lead our dedicated team of laboratory technicians. You will be assisted by a team coordinator to enable you to focus on continuous improvement of our processes and development of the team. In addition, you will have the opportunity to use and develop your professional expertise by contributing to analytical development activities for selected projects. You will work closely with the scientific team to ensure appropriate estimation, allocation and prioritization of resources for our development projects. In this key role, you will be responsible for ensuring that results are delivered to agreed timelines and quality standards to ensure that projects can proceed without delay.
What are you going to work with – further highlights
- Leadership and professional development of our dedicated team of laboratory technicians
- Optimization, maintenance and automation of processes, procedures and equipment - with an eye on LEAN and continuous improvement
- Monitoring and further developing relevant laboratory KPIs relating to performance and quality
- Promoting and ensuring the correct application / interpretation of Ph. Eur and GMP
- Development and maintenance of an appropriate scientific knowledge base, particularly in relation to relevant analytical techniques
- Participation in project teams, in particular contributing to and leading analytical development for selected projects
- Development and optimization of analytical methods in connection with new product development
- Analytical method transfer to our commercial QC laboratory or external laboratories
- Preparing, updating and reviewing quality SOPs
- Qualification and maintenance of analytical equipment, mainly HPLC and dissolution
Who are you?
You have an academic and professional background in analytical chemistry or pharmacy or a closely-related field and a minimum of 3-5 years laboratory management experience. Solid experience in the pharmaceutical industry, particularly in drug product development, is a strong plus. You enjoy working in accordance with GMP and are used to working with quality systems. In terms of personal skills:
- You have a positiv attitude and a development-oriented mindset
- You are enthusiastic, careful, structured and fast-moving
- You have a flexible mind-set and can ensure that the team can react and prioritize efficiently in support of our fast moving and continually evolving development projects.
- You find it natural to set the scene and lead your team to react and prioritize properly
- You are a hands-on person and good at troubleshooting
- You pay attention to ensuring a good atmosphere and support a positive collaboration
- You are good at building and maintaining relationships
By choosing a position in Orifarm MV, you will have the opportunity to help set the agenda and thus greatly influence your own daily life. We thrive in making idea to implementation, and decisions are made quickly. You will be part of a company where employees are the driving force.
Primary work location is Skælskør and we are proud to be a flexible workplace which offers good opportunities to work partly from home or one of our offices in Odense or Søborg
Please send your application electronically to (HR portal) as soon as possible and no later than 16th August 2021. Applications will be evaluated on a continuous basis.
Ansøgningsfrist:16. august 2021