Principal Drug Substance Scientist (Biologics)
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Ballerup
Do you want to work with our new biological products and make a difference that matters?
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. Right now, we are on a very important journey with our new biologic products. You will enter LEO Pharma at the most exciting period of time.
Come join us! Responsibility, exciting challenges, on-going development, good colleagues and massive impact are guaranteed in this position.
In Global Manufacturing Science And Technology (MSAT) you will get the opportunity to make a significant difference for people with serious skin diseases all over the world. Global MSAT is part of Global Product Supply and in Global MSAT we are counting approx. 80 persons in seven departments situated in Ballerup, Italy, France and Ireland.
The job
In Global MSAT PPS (Pharmaceutical Product Support) we provide an interesting opportunity to use your expert knowledge and experiences within development and commercial manufacture of biologic drug substances. We have just recently started supporting our new marketed biological products and you will be part of our journey in a dynamic team and will be able to impact our ways of working and onboard your future colleagues! Both the biologic drug products and drug substances are manufactured externally at CMO´s.
You will be part of the Formulation Support team and participate in building up new competences within biologics and mainly drug substances.
Your primary tasks will be:
- Write, update and approve process documentation for registration purposes in connection to manufacturing projects, questions from authorities and applications for variations for LEO-Pharma marketed products, mainly for biologic drug substances.
- Participate in cross-organizational projects across LEO Pharma together with our Global MSAT biologic departments and CMO management departments.
- Coordinate or participate in ad hoc department tasks, e.g., root cause investigations
- Support our biologics departments in Global MSAT and CMOs with process/production changes or challenges.
Your qualifications
MSc or PhD degree in Pharm/Engineering/Chemistry or related field.
Work experience:
- You have more than 10 years of experience working with biologic products within the field of manufacturing or development of processes of biologic drug substances e.g., antibodies
- You have comprehensive experience writing and updating regulatory module 3 documentation
- You have comprehensive experience answering questions from Health Authorities
- You have effective communication skills and are proficient in English – both spoken and written
- You have experience in supporting commercial Drug Substance productions e.g., root cause investigation, risk assessments
- You have experience with CMO collaboration with external partners
You will thrive in Global MSAT PPS if you:
- are responsible, flexible, and a competent decision-maker
- are service minded
- have strong collaboration skills
- have a can-do attitude
- work independently and systematically
- enjoy knowledge sharing with your colleagues
- support your close colleagues to meet project deadlines
- are good at switching between tasks in long term projects and tasks with short deadlines
Your new team
You will be based at the LEO headquarters in Ballerup, Greater Copenhagen and will join a team of four highly skilled, dedicated and enthusiastic specialists who primarily support small molecules products. Our focus is to provide scientific support for all marketed products in LEO Pharma, focusing on process and formulation aspects within small molecules and BioPharm. Your primary product focus will be our drug substances for the biologic products
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma, you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application
If you have questions, please do not hesitate to contact Birgitte Wenzell Olesen, Senior Manager, at + 45 25 66 4117. .
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.
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 23.2.2022, 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
- Mandag den 04. april 2022
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