Principal Formulation Scientists – Biopharmaceutical products
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Are you a biopharmaceutical scientist with experience of formulation development and aseptic fill & finish processes for proteins and interested in a job with impact, exciting scientific challenges and the opportunity to use and develop your strategic mindset? Then this may be just 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 2025 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 LEO 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 ofmonoclonal antibodies (mAbs). This is why we need you!
THE JOB
In Biopharmaceutical Products you will join 14 highly skilled and experienced persons constituted by Formulation and Analytical Scientists and Technicians, all with the focus of developing biologics products from discovery to market as well as supporting commercial manufacturing and post launch activities (LCM). 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, module 3 documentation, feasibility studies and IMP productions.
As the principal formulation scientist your essential tasks will be:
QUALIFICATIONS
We expect the ideal candidate to:
ADDITIONAL INFORMATION
For additional information, please contact Senior Manager Sonja Jespersen; [email protected]. Send your application and CV in English as soon as possible and no later than 9th Aug 2020 as we will review incoming applications on an on-going basis.
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 2025 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 LEO 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 ofmonoclonal antibodies (mAbs). This is why we need you!
THE JOB
In Biopharmaceutical Products you will join 14 highly skilled and experienced persons constituted by Formulation and Analytical Scientists and Technicians, all with the focus of developing biologics products from discovery to market as well as supporting commercial manufacturing and post launch activities (LCM). 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, module 3 documentation, feasibility studies and IMP productions.
As the principal formulation scientist your essential tasks will be:
- 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 formulations and manufacturing processes for proteins, including GMP manufacturing, process scale-up/optimization using Quality by Design principles and validation activities at contract manufacturers
- Manage selection and oversight of contract manufacturers (CDMOs)
- Coordinate activities at contract laboratories and contract manufacturers assuring adherence to agreed timelines
- Lead transfer of technology activities to third party manufacturers
- Write, elaborate and contribute to relevant regulatory documents
- Initiate/introduce new scientific know-how and keep an updated scientific and regulatory knowledge in the areas of formulation development, pharmaceutical manufacturing and process scale-up/validation
- Coach and train colleagues within formulation / Fill& Finish activities for Biologics
QUALIFICATIONS
We expect the ideal candidate to:
- Have minimum a M.Sc. in pharmaceutical sciences, chemical engineering or equivalent education preferable a Ph.D.
- Have at least 5 years of relevant experience from biopharmaceutical industry
- Have proven scientific skills in formulation development and/or process scale-up, primarily within aseptic/sterile technology preferable also freeze-drying formulations
- Have experience in outsourcing and coordinating activities with CDMO/CROs
- Be familiar with GMP and have experience in pharmaceutical manufacturing
- 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 Sonja Jespersen; [email protected]. Send your application and CV in English as soon as possible and no later than 9th Aug 2020 as we will review incoming applications on an on-going basis.
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 15.7.2020, 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 09. august 2020
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