Senior Scientist - Upstream
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Are you passionate about upstream process development? Are you a team player that thrives with project focused work? Do you want to be part of developing the biologics drug substance process capabilities within LEO Pharma?
If YES, I strongly urge you to apply for the vacant position as Senior Upstream Scientist in our team focusing on biopharmaceutical drug substance development - The department of Biopharm Process Development
In this role, you will be part of implementing the 2030 strategy for building drug substance capabilities within LEO and you will actively contribute to our mAbs projects from research to launch.
The job – roles and responsibilities
As Senior Upstream scientist you will join a team of highly skilled and experienced upstream and downstream Scientists and Technicians, all with the focus on developing biologics products from discovery to launch. All our projects are run as external partnerships with extensive CDMO/CRO collaborations. The department you will join is responsible for all drug substance bio process activities throughout the full development value chain for monoclonal antibodies, including; cell line selection and development, DS process development and DS productions and IMPD/CTD (module 3) documentation. We have established state of the art internal laboratories and capabilities and the work in the Biopharm Process Development department is constituted by a mix of work performed at CDMO´s and internal process development activities. The Biopharm Process Development department is working closely with the Biopharm Analytical Development and Biopharm Product Development departments, that are responsible for the analytical/protein characterization work as well as the formulation/fill & finish development.
We are offering a job where you will:
- Work in mAbs projects from Research to launch
- Plan, execute (together with our skilled technicians) and report internal upstream experiments performed in our top modern in-house upstream laboratories
- Help to further maintain and develop our upstream capabilities and competences
- Present scientific results within the team or with other stakeholders during CMC project meetings
- Be an active member of the CMC team, representing upstream drug substance process
- Work with partners and C(D)MOs where the main part of the process development is performed
- Review and write sections of IMPD and CTD documentation (Module 3) and interact with authorities in Q/A processes and inspections
Your qualifications
You have:
- A university degree (preferably PhD) within natural sciences
- At least a few years of relevant experience from the biopharmaceutical industry on upstream processes in R&D and/or commercial manufacturing
- Insights into upstream processes in small scale and manufacture scale
- Knowledge of FDA, EMA and ICH guidelines for drug substance CMC development
- An interest in working with external partners and CRO´s/CDMO´s
- Strong collaboration skills, are well organized and have a will to work in cross-functional teams
As a person, you like to share your knowledge actively and participate in an open dialogue. You are capable to work with several tasks in parallel and enjoy a work environment where we, initially, draw the map as we go. You are good at prioritizing your tasks and can work independently.
About LEO Pharma
LEO Pharma is a research-based pharmaceutical company headquartered in Denmark, currently employing 6000 professionals across 60 countries. LEO Pharma drives dermatology and helps people achieve healthy skin by supplying treatments to people with medical needs in more than 130 countries around the world. LEO Pharma has an ambitious 2030 strategy, which aims to accelerate the impact in innovative therapeutics while strengthening the established portfolio and global footprint in medical dermatology. To meet the requirements of an increasing pipeline of biologics projects we are now expanding in the CMC biologics area both in terms of capabilities and capacity.
Contact and application
If you have questions, please do not hesitate to contact me, Fredrik Johansson (Head of Biopharmaceutical CMC Development) - or Christoffer Bro (Senior Principal Scientist – Biopharmaceutical Process Development)
Please note that interviews will be held on a running basis and may therefore be held before application deadline.
. The deadline is 09.06, 2021.
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 21.5.2021, 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 09. juni 2021
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