id: NDkzNDgzMSA3

reference: 4934831

documentId: 4934831

connectionPointId: 7

lastModificationDate: 1548247391696

stillingsbetegnelse:
Senior Scientist - biopharmaceutical development and support

jobbeskrivelse:

Biopharmaceutical Processes is looking for a Senior Scientist to work on late stage biologics projects (mainly mAbs) where you will be responsible for the drug substance part in the CMC team. You will review process changes and help prepare regulatory documentation in close collaboration with internal and external stakeholders. In addition, there will be opportunities to participate in projects in discovery / early stage as well as supporting established commercial biological products.  

LEO Pharma has moved into biologics for treatment of skin diseases with several monoclonal antibodies (mAbs) in both late and early stage development. Now is the right time for LEO to take the next step towards building up internal CMC capabilities within biologics in R&D. Strong capabilities within bioprocess development is crucial for LEO Pharma to develop and understand our biopharmaceutical products and manufacturing processes.

Two departments have recently been established: Biopharmaceutical Processes, the center of excellence for manufacturing processes related to mAbs and other biological APIs in LEO focusing on drug substance related CMC and support activities. Biopharmaceutical Products, the LEO Pharma center of excellence for formulation and analytical science related to mAbs, focusing on drug product related CMC activities within LEO Pharma.

 Strategically important

One of the key and initial steps is the establishment of the capabilities within manufacturing of drug substance (mAbs). This capability will be used to support early and late stage development as well as commercial manufacturing at external partners. Building of laboratories for upstream and downstream process development are ongoing and will soon be completed.

Being part of the team is a unique opportunity pioneering biologics at LEO and setting the direction on how LEO will work with biologics.

 

Job abstractJV_description

You will be working across in-house laboratory activities, guidance of external partners and CMOs for the manufacturing supply and tech transfer to external (CMOs) of drug substance.

Review and write sections of Module 3 documentation, review and contribute to protocol and report writing.

Support the product life cycle with knowledge within cell culture and / or purification processes. You will participate in collaborations with internal and external partners from early discovery, through process development through upscaling / Tech transfer to commercial manufacturing at CMOs.

 Qualifications and experience

MSc or PhD with 2+ years relevant experience, preferably within development and/ or manufacturing of biopharmaceutical drug substance (preferably, mAbs).

As a person, you are outward going, motivated to learn new skills and not afraid of reaching out to colleagues for guidance. You are capable of working 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.

 

Biopharmaceutical Processes

The department, Biopharmaceutical Processes, is a newly established department. We are currently  a small team of 10 people and will expand as we build up our capabilities. The primary focus is to support LEO Pharma´s portfolio of monoclonal antibodies within process development and process understanding. We will be working very closely together with the ‘sister department’, ‘Biopharmaceutical Products’, to cover the full value chain of the biologics projects and products in LEO.

We work across the R&D function and operations as well as through external partners for the manufacturing and supply of our products. Over the coming years, we will be responsible for developing the biologics CMC capabilities within LEO in support of LEO Pharmas´s aspiration to provide biologics drugs for skin diseases to help patients achieve healthy skin.

 

Do you want to be part of the team that will define how we work with Biologics at LEO Pharma? In such case, we look forward to receiving your application no later than 4 February 2019.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2310

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR