Principal Analytical Scientist
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For Biopharmaceutical Products
Biopharmaceutical Products are looking for an experienced analytical scientist for late stage development and implementation support to monoclonal antibodies drug products.
LEO Pharma has moved into biologics for treatment of skin diseases with several monoclonal antibodies (mAbs) in both late and early stage development. LEO is now well on its way towards building up internal CMC biologics capabilities within R&D.
Two departments has been established to take on this exiting journey towards the building up of internal capabilities: Biopharmaceutical Processes is the center of excellence for bio-processes and will have focus on the drug substance. Biopharmaceutical Products is the LEO Pharma center of excellence for formulation and analytical science related to biologics and will have the focus on the drug product related CMC activities.
For the Biopharmaceutical Products experience within analytical and stability for biologics and strong CMC documentation skills are key for LEO Pharma to do the submission for approval and launch of new biological products.
The position
LEO is taking over increased responsibilities from external collaborations and to accommodate this change we are ramping-up on late-stage CMC drug product capabilities.
Being part of a late stage project team is a unique opportunity to be pioneering within biologics at LEO and to build relationships and working experience for externalised projects.
Being the LEO subject matter expert support for collaboration with external analytics CRO´s and development partners on an ongoing basis. This also includes some travel activities for face-to-face meetings and on-site participation.
Your main role will be:
Provide guidance and interpretation of stability data. Perform analytical methods development, validation, transfer and troubleshooting – develop analytical strategies and propose solutions. Write and/or review protocols and reports for stability, analytical methods, including setting specifications and writing of regulatory module 3 sections.
Qualifications
Pharmacist, chemical engineer or similar education with at least 10 years’ late-stage experience from CMC development of monoclonal antibody drug products or biologics.
Hands on experience from analytical development, validation, stability data interpretation, specifications, shelf-life statements and writing of regulatory documentation on pharmaceutical development and manufacturing for monoclonal antibodies.
As a person you have to have an entrepreneurial spirit, collaborative mindset and cross cultural collaboration skills are needed.
About the department
The department, Biopharmaceutical Products, is a newly established department. We are currently team of 12 people and we will expand the team gradually as LEO gets further engaged into biologics projects. The primary focus is to support LEOs portfolio of monoclonal antibodies within analysis and formulation. We will be working very closely together with the “sister department”, Biopharmaceutical Processes”, to cover the full value chain of the biologics projects and products in LEO.
We work across the R&D function and product supply organisation. We work through external partners for the manufacturing, analysis and supply of our products and, at the same the time we will be responsible for developing the capabilities of LEO for embarking further on the treatment skin diseases with Biologics.
Biopharmaceutical Products are looking for an experienced analytical scientist for late stage development and implementation support to monoclonal antibodies drug products.
LEO Pharma has moved into biologics for treatment of skin diseases with several monoclonal antibodies (mAbs) in both late and early stage development. LEO is now well on its way towards building up internal CMC biologics capabilities within R&D.
Two departments has been established to take on this exiting journey towards the building up of internal capabilities: Biopharmaceutical Processes is the center of excellence for bio-processes and will have focus on the drug substance. Biopharmaceutical Products is the LEO Pharma center of excellence for formulation and analytical science related to biologics and will have the focus on the drug product related CMC activities.
For the Biopharmaceutical Products experience within analytical and stability for biologics and strong CMC documentation skills are key for LEO Pharma to do the submission for approval and launch of new biological products.
The position
LEO is taking over increased responsibilities from external collaborations and to accommodate this change we are ramping-up on late-stage CMC drug product capabilities.
Being part of a late stage project team is a unique opportunity to be pioneering within biologics at LEO and to build relationships and working experience for externalised projects.
Being the LEO subject matter expert support for collaboration with external analytics CRO´s and development partners on an ongoing basis. This also includes some travel activities for face-to-face meetings and on-site participation.
Your main role will be:
Qualifications
Pharmacist, chemical engineer or similar education with at least 10 years’ late-stage experience from CMC development of monoclonal antibody drug products or biologics.
Hands on experience from analytical development, validation, stability data interpretation, specifications, shelf-life statements and writing of regulatory documentation on pharmaceutical development and manufacturing for monoclonal antibodies.
As a person you have to have an entrepreneurial spirit, collaborative mindset and cross cultural collaboration skills are needed.
About the department
The department, Biopharmaceutical Products, is a newly established department. We are currently team of 12 people and we will expand the team gradually as LEO gets further engaged into biologics projects. The primary focus is to support LEOs portfolio of monoclonal antibodies within analysis and formulation. We will be working very closely together with the “sister department”, Biopharmaceutical Processes”, to cover the full value chain of the biologics projects and products in LEO.
We work across the R&D function and product supply organisation. We work through external partners for the manufacturing, analysis and supply of our products and, at the same the time we will be responsible for developing the capabilities of LEO for embarking further on the treatment skin diseases with Biologics.
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 27.6.2019, 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 31. juli 2019
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