Principal Drug Product Specialists
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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. Come join us!
We are currently looking for a Principal Drug Product Specialists, who can take part in advancing LEO Pharma’s exciting pipeline of antibody products.
You will join the Global MSAT Biologics FP department, which is responsible for oversight of drug product manufacturing and AL&P processes for commercialized biologics at external partners. Furthermore, the role acts as the departments accountable resource of documentation for the authorities.
In Global Manufacturing Science & 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 approx. 80 persons in seven departments placed in Denmark, Italy, France and Ireland.
The job
In Global MSAT Biologics FP (Finished Product) we provide a unique opportunity to use your gained knowledge and experiences within late-stage development and commercial manufacture of biologics. LEO Pharma have just recently marketed a new biological product in EU and US and you will be entering a newer dynamic team, where you will be able to impact our ways of working and help ensuring successful transfers of our future Biologics in LEO Pharma manufactured externally at CMO's worldwide.
You will be part of the Fill Finish support team and participate in building up new competences within biologics and mainly drug product formulation.
Your primary tasks will be:
- Development of processes suitable for drug product GMP manufacture
- Scientific oversight of drug product activities outsourced to external partners
- Provide technical oversight and support to our external partners (CDMOs) with process/production changes or challenges.
- Write, update, and approve process documentation for registration purposes in connection to manufacturing projects, QnA from authorities and applications for variations for LEO-Pharma marketed Biologics
- Participate in cross-organizational projects across LEO Pharma together with our Global MSAT departments and External Manufacturing departments
- Coordinate or participate in ad hoc department tasks, e.g., root cause investigations
Your Qualifications
Your qualifications are several years of experience from the pharmaceutical industry with aseptic drug product manufacturing of biopharmaceuticals incl. cGMP and regulatory aspects.
Moreover, you possess solid knowledge about the physical and chemical properties of proteins and it’s an advantage if you have experience with formulation development and experience in collaborating with CMOs.
Preferably, you also have experience with characterization and compatibility studies and/or extractable and leachable evaluation.
Work experience:
- BSc or MSc degree in Pharm/Engineering/Chemistry or related field.
- You have more than 10 years of experience working with biologic products within the fields of manufacturing or development of aseptic processes of biologic Drug Products
- You have experience in supporting commercial Drug Product productions e.g., root cause investigation, risk assessments
- You have experience with collaboration with external partners (CMOs)
- You have comprehensive experience writing and updating regulatory module 3 documentation and experience answering questions from Health Authorities
- You have effective communication skills and are proficient in English - both spoken and written
You will thrive in Global MSAT Biologics FP if:
You as a person, are self-driven, highly motivated, a team player with commitment, initiative, and humor. You possess an attention to detail and the ability to work in a team-oriented culture, where knowledge sharing and idea generation with peers is key for advancing our next biological products.
Finally, you are to work efficiently, have a can-do attitude, are good at switching between tasks in long term projects and goal-oriented in a multi-disciplinary setting with many different priorities which therefore often leads to 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 six highly skilled, dedicated, and enthusiastic specialists who primarily support biologics products.
Our focus is to provide scientific support for all marketed biologics in LEO Pharma, focusing on process and formulation aspects within aseptic manufacturing of Drug Product and Finished Goods manufacturing 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 Martin Vorborg, Senior Manager, at + 45 3175 9678.
.
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 "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 29.3.2022, 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.
- Produktspecialist
- Ballerup
- Søndag den 10. april 2022
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