Biopharmaceutical Products are looking for a formulation 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 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 strong CMC documentation skills and manufacturing knowledge are key for LEO Pharma to do the submission for approval and launch of new biological products.
LEO is taking over increased responsibilities from external collaborations and to accommodate this change We are ramping-up to 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.
Collaboration with external manufacturing and development partners and provide subject matter expert support on an ongoing basis. This also includes some travel activities for face-to-face meetings and on-site participation.
Write and/or review protocols and reports, including regulatory module 3 sections.
Provide guidance and interpretation of manufacturing process data and troubleshooting – propose solutions.
Participate in drug product manufacturing process tech transfers, including on-site participation at CMO´s.
Pharmacist, chemical engineer or similar education with at least 5 years’ late-stage experience from CMC development of monoclonal antibody drug products or biologics.
Hands on experience from formulation development, aseptic Fill&Finish operations and writing of regulatory documentation on pharmaceutical development and manufacturing.
As a person you have to have an entrepreneurial spirit, collaborative mindset and cross cultural collaboration skills are needed.
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 operations. We work through external partners for the manufacturing 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 biologics drugs for skin diseases.
Please do not hesitate to contact Senior Manager Lars Lindgaard Hansen, +45 20999866 if you want to know more about the position.
We look forward to receiving your application. Deadline is 2 August, 2018. Please note that applications will be reviewed regularly as they come, so please send your application as soon as possible.