Senior Formulation Scientist
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Ballerup
(temporary position)
For Biopharmaceutical Products
Biopharmaceutical Products is seeking a 12 months temporary Senior Formulation Scientist for drug product and manufacturing process implementation of monoclonal antibody drug products.
LEO Pharma is developing a strong pipeline of biologic treatments for skin diseases with several monoclonal antibodies (mAbs) in early and late stage development.
Two departments have been established to be our CMC centers of excellence: Biopharmaceutical Processes focuses on bio-processes for drug substance and Biopharmaceutical Products is responsible for formulation and analytical science for drug product CMC activities.
One of our Senior Formulation Scientists is going on maternity leave and we are looking for a person with strong formulation skills and manufacturing knowledge for the development, submission and launch of new biological products.
The position
This position as a senior formulation scientist provides an exciting opportunity to be a part of the key biologics’ competences within LEO Pharma and to participate in project teams, developing new and innovative treatments for patients suffering from skin diseases.
You will be working across the organization and provide guidance for external partners and CMOs on the development, manufacturing and supply of injectable biologics drugs.
Your main role will be:
Write and/or review regulatory CMC documentation sections for formulation development and drug product manufacturing. Participate in drug product manufacturing process tech transfers, including on-site participation at CMOs. Collaborate with external manufacturing and development partners and provide subject matter expertise. The position includes travel activities.
Qualifications
You will have a relevant educational background as Master or Ph.D. within pharmaceutical sciences or another relevant area and at least 3 years late-stage experience from formulation development of monoclonal antibody drug products.
Industrial hands-on experience of formulation development of injectables, aseptic Fill & Finish operations and writing of regulatory documentation on pharmaceutical development and manufacturing.
Experience from working with external partners and CMOs.
Personally, you need an entrepreneurial spirit, good planning and cross-cultural collaboration skills.
About the department
The Biopharmaceutical Products Department was established in 2017 and constitutes a dynamic team of 12 highly professional, experienced colleagues. The primary focus is to support LEOs portfolio of monoclonal antibodies within analysis and formulation, working closely with Biopharmaceutical Processes (upstream/downstream processing) colleagues.
We work across the R&D function, operations and with external partners for manufacturing and supply of our products and are strengthening LEO’s capabilities for future biologic drugs for skin diseases.
We offer an opportunity to have great impact on the R&D area in LEO Pharma.
You can expect an exciting, challenging and fun working environment alongside a good work-life balance.
For Biopharmaceutical Products
Biopharmaceutical Products is seeking a 12 months temporary Senior Formulation Scientist for drug product and manufacturing process implementation of monoclonal antibody drug products.
LEO Pharma is developing a strong pipeline of biologic treatments for skin diseases with several monoclonal antibodies (mAbs) in early and late stage development.
Two departments have been established to be our CMC centers of excellence: Biopharmaceutical Processes focuses on bio-processes for drug substance and Biopharmaceutical Products is responsible for formulation and analytical science for drug product CMC activities.
One of our Senior Formulation Scientists is going on maternity leave and we are looking for a person with strong formulation skills and manufacturing knowledge for the development, submission and launch of new biological products.
The position
This position as a senior formulation scientist provides an exciting opportunity to be a part of the key biologics’ competences within LEO Pharma and to participate in project teams, developing new and innovative treatments for patients suffering from skin diseases.
You will be working across the organization and provide guidance for external partners and CMOs on the development, manufacturing and supply of injectable biologics drugs.
Your main role will be:
Qualifications
You will have a relevant educational background as Master or Ph.D. within pharmaceutical sciences or another relevant area and at least 3 years late-stage experience from formulation development of monoclonal antibody drug products.
Industrial hands-on experience of formulation development of injectables, aseptic Fill & Finish operations and writing of regulatory documentation on pharmaceutical development and manufacturing.
Experience from working with external partners and CMOs.
Personally, you need an entrepreneurial spirit, good planning and cross-cultural collaboration skills.
About the department
The Biopharmaceutical Products Department was established in 2017 and constitutes a dynamic team of 12 highly professional, experienced colleagues. The primary focus is to support LEOs portfolio of monoclonal antibodies within analysis and formulation, working closely with Biopharmaceutical Processes (upstream/downstream processing) colleagues.
We work across the R&D function, operations and with external partners for manufacturing and supply of our products and are strengthening LEO’s capabilities for future biologic drugs for skin diseases.
We offer an opportunity to have great impact on the R&D area in LEO Pharma.
You can expect an exciting, challenging and fun working environment alongside a good work-life balance.
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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