Senior Scientist – Protein Characterization and Analytical Development
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Are you passionate about analytical development and protein characterization? Are you a team player that thrives with project focused work? Do you want to be part of developing and building characterization of biologics drugs capabilities within LEO Pharma?
If YES, I strongly urge you to apply for the vacant position as Senior Scientist in our team focusing on biopharmaceutical analytical development - The department of Biopharm Analytical Development.
In this role, you will be part of implementing the 2030 strategy for building analytical capabilities within LEO Pharma in CMC D&D and you will actively contribute to our mAbs projects from research to launch.
The job
As senior analytical scientist you will join a team of highly skilled and experienced analytical scientists and technicians, all with the focus on developing biologics products from research to launch. All our projects are run as external partnerships with extensive CDMO/CRO collaborations. The department you will join is responsible for all analytical activities throughout the full development value chain for monoclonal antibodies, including; DS/DP characterization on in-house produced materials, impurity characterization, accelerated stability studies, candidate selection support, formulation candidates support and IMPD/CTD documentation.
We have established state of the art internal laboratories and capabilities and the work in the Biopharm Analytical Development department is constituted by a mix of work performed at CDMO´s and internal mAb characterization activities. The Biopharm Analytical Development department is working closely with the Biopharm Process Development and Biopharm Product Development departments, that are responsible for the upstream/downstream drug substance processes as well as the formulation/fill & finish development.
We are offering a job where you will:
- Work in mAbs projects from Research to clinical Phase 2
- Plan, execute (together with our skilled technicians and scientists) and report internal experiments performed on our modern equipment including high end MS equipment
- Work with important LC-MS characterisation methods like intact mass analyses, subunit mass analyses and peptide mapping, together with conventional characterisation methods for size variants (SEC/CE-SDS) and charge variants (CIEX/CIEF) including hands-on and data processing.
- Supervision, guidance, and technical lead of lab technicians
- Keep on par with instrumentation for mAb characterization
- Help to further maintain and develop our characterization capabilities and competences with focus on support to middle to late stage development and characterization for IMPD/CTD documentation
- Present scientific results within the team and for other stakeholders during CMC project meetings
- Be an active member of the CMC team, representing analytical development
- Review and write sections of IMPD and CTD documentation (Module 3) and interact with authorities in Q&A processes
Your qualifications
- A university degree (preferably PhD) within natural sciences
- At least a few years of relevant experience from the biopharmaceutical industry on analytical biologics characterization using high end LC-MS, preferably for characterization of mAbs
- Knowledge of FDA, EMA and ICH guidelines for Analytical Development and characterization of biologics
- An interest in working with external partners and CRO´s/CDMO´s as well as working with internal laboratory activities
- 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, Christer Andersson (Head of Biopharm Analytical Development, mobile+45 31385986) - or Lars Dencker Nielsen (Principal Scientist – Biopharm Analytical Development , mobile +45 22453582)
Please note that interviews will be held on a running basis and may therefore be held before application deadline.
. The deadline is 19-September-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 7.9.2021, 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
- Søndag den 19. september 2021
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