Principal Analytical Scientist within mAbs and Biologicals for LCM activities
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Are you passionate about improving lives of millions of people by supporting LEO Pharma marketed products within biologicals and small molecules?
This is your chance to join one of the world’s leading companies within dermatology and to set your mark on the quality of life for millions of patients around the world. In LEO Pharma we devote our efforts to develop innovative drugs for the treatment of skin diseases like psoriasis and eczema. You can look forward to becoming part of a team with high professional standards in an informal atmosphere where tasks vary, and no days are alike.
Great opportunity within CMC MA Support
CMC MA Support is part of Pharmaceutical Product Support counting 49 persons divided into three departments. We provide fast, efficient and qualified pharmaceutical documentation and analytical support for all marketed products at LEO Pharma.
You will join 17 enthusiastic and dedicated colleagues in the CMC MA Support department in Pharmaceutical Product Support. Our focus is on LEO Pharma marketed products and connected LCM activities.
As a Principal Scientist you will be responsible for one or more biologic marketed products. You will have a counterpart in the CMC Stability Support department and it is expected that you to some extent can support in setting up stability studies according to ICH and other relevant guidelines, be a part of OOS investigations and perform analytical and chemical trouble shooting, mainly for biologic products.
Our values are impact, enterprise thinking, courage, trust and mutual respect and helpfulness – and we care about each other. As a support area, Pharmaceutical Product Support receives many unforeseen and urgent enquiries, and you must therefore be able to juggle a number of tasks and work on several projects at the same time.
Primary areas of responsibility:
You will be part of the department responsible for answering authority questions regarding analytical and stability issues, maintaining and creating new module 3 documentation and set the response strategy together with our Pharmaceutical Experts and Regulatory Affairs.
As a part of your daily tasks you will be expected to be:
- Answering authority questions
- Writing and updating module 3 documentation for regulatory purposes in connection with maintenance and projects
- Part of renewals and preparation of new MA´s
- Participating in projects across the LEO organization globally
- Participating in ssetting up stability studies, planning and executing analytical development and validation and contribute to OOS investigations
The ideal candidate:
The ideal candidate has profound analytical experience within biologicals (mAbs), is a team player with strong collaboration skills, outgoing, tolerant and solution oriented. You are responsible, flexible, and a competent decision-maker. You freely share knowledge to colleagues and thrive in being a go-to person for advice on analytical matters. You are fully familiar with working under GMP and in regulated environments and have the business perspective to weigh cost and risks in a pragmatic balance.
Your experience and competences:
- Master of Science in e.g. Pharmacy, Engineering or Chemistry perhaps in combination with a PhD
- Have solid and relevant experience from biopharmaceutical industry. Experience within small molecule pharmaceutical industry is considered an additional advantage.
- You have 5+ years of experience with different aspects of pharmaceutical registration documentation and requirements both from a scientific and a CMC regulatory perspective
- A minimum of 10 years of experience within analytical chemistry, specification setting and stability testing, strong end-to-end CMC understanding, including insight in development.
- You have experience in working with Partners, CMOs/CROs and HA appointed local laboratories and have proven skills for creating a good collaboration atmosphere
- Experience with technical transfer of analytical methods
- Excellent stakeholder management skills and experience in working in multi-cultural project teams
- A solid experience with GMP as we work in regulated areas including experience with HA audits
- Good communication skills (English and Danish/Scandinavian)
- Preferably LEAN experience or experience with continuous improvements
Further information
Do not hesitate to contact Senior Manager Birgitte Wenzell Olesen, +45 2566 4117 if you want to know more about the position.
We look forward to receiving your application.
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 1.4.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forsker
- Ballerup
- Onsdag den 14. april 2021
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