Senior Analytical Scientist – Biopharmaceutical Products
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Are you a biopharmaceutical scientist with experiences in characterization and analytical development of proteins in late stage clinical development and are you looking for a job with exciting scientific challenges and the opportunity to use and develop your strategic mindset? Do you have experience from working with external partners and CRO/CMO´s, and is this something that gives you energy? Then this may just be the job for you.
LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world, dedicated to help people achieve healthy skin. We have an ambitious 2030 strategy, which aims to accelerate our impact in innovative therapeutics while strengthening our established portfolio and our global footprint in medical dermatology. Dermatology is an area of rapid growth and LEO Pharma´s vision is to reach 125 mill. patients worldwide by 2025. Biopharmaceutical Products is one of two departments (the other being Biopharmaceutical Processes) within CMC Design and Development within LEO Pharma focusing on the CMC development of biologics. The departments were started in 2017 with a strong focus on building biologics CMC capabilities within LEO to support a growing pipeline on monoclonal antibodies (mAbs). We will start with the next step in our growth journey and that’s why we need you!
THE JOB
In Biopharmaceutical Products, you will join 17 highly skilled and experienced persons constituted by Formulation and Analytical Scientists and Technicians, all with the focus on developing biologics products from discovery to market. All projects are run as external partnerships with extensive CDMO/CRO collaborations. The department is responsible for all CMC product activities throughout the full value chain for monoclonal antibodies including; developability studies, development of formulations and analytical methods, preparation of module 3 documentation, feasibility studies and IMP productions.
As a senior analytical scientist your essential tasks will be
QUALIFICATIONS
We expect the ideal candidate to:
ADDITIONAL INFORMATION
For additional information, please contact Senior Manager Christer Andersson +45 31385986 , [email protected]. Deadline for application January 3rd 2021. We will review incoming applications on an on-going basis, so please do not hesistate in sending us your CV and motivated letter of interest in English. We look forward to hearing from you.
LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world, dedicated to help people achieve healthy skin. We have an ambitious 2030 strategy, which aims to accelerate our impact in innovative therapeutics while strengthening our established portfolio and our global footprint in medical dermatology. Dermatology is an area of rapid growth and LEO Pharma´s vision is to reach 125 mill. patients worldwide by 2025. Biopharmaceutical Products is one of two departments (the other being Biopharmaceutical Processes) within CMC Design and Development within LEO Pharma focusing on the CMC development of biologics. The departments were started in 2017 with a strong focus on building biologics CMC capabilities within LEO to support a growing pipeline on monoclonal antibodies (mAbs). We will start with the next step in our growth journey and that’s why we need you!
THE JOB
In Biopharmaceutical Products, you will join 17 highly skilled and experienced persons constituted by Formulation and Analytical Scientists and Technicians, all with the focus on developing biologics products from discovery to market. All projects are run as external partnerships with extensive CDMO/CRO collaborations. The department is responsible for all CMC product activities throughout the full value chain for monoclonal antibodies including; developability studies, development of formulations and analytical methods, preparation of module 3 documentation, feasibility studies and IMP productions.
As a senior analytical scientist your essential tasks will be
- Contribute setting development strategies for activities associated with our mAb products
- Participate in CMC teams and project work. Collaborate with team members from different departments within development
- Lead, plan and document development work related to characterization, release testing, stability studies, specifications and reference standards, as well as analytical method development, validation and transfer
- Manage selection and oversight of contract laboratories and contract manufacturers for analytical workpackages
- Coordinate activities at CRO/CDMO assuring adherence to agreed timelines and quality standards
- Write, elaborate and contribute to relevant regulatory documents • Keep an updated scientific and regulatory knowledge in the areas of analytical development and characterisation of proteins
QUALIFICATIONS
We expect the ideal candidate to:
- Have minimum a M.Sc. but preferable a Ph.D. in pharmaceutical sciences, chemical engineering or equivalent education
- Have at least 3 years of relevant experience from biopharmaceutical industry
- Have proven scientific skills in analytical development for protein in late phase development (Phase 3), experience with potency assay is a plus
- Have experience in outsourcing and coordinating activities with CMO/CROs
- Be familiar with GMP and regulatory guidelines
- Be able to obtain a good overview, prioritize and take full responsibility of an assignment
- Be innovative, flexible and quality minded
- Have excellent communication skills and be fluent in English, both spoken and written.
ADDITIONAL INFORMATION
For additional information, please contact Senior Manager Christer Andersson +45 31385986 , [email protected]. Deadline for application January 3rd 2021. We will review incoming applications on an on-going basis, so please do not hesistate in sending us your CV and motivated letter of interest in English. We look forward to hearing from you.
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 18.11.2020, 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 03. januar 2021
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