Biologics Development Leader

Date: 14-Aug-2022

Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain

Company: Almirall

Mission

The Almirall R&D team in Barcelona is building up the Biologics Development department and is looking for a talented and experienced leader. The Biologics Development department is responsible for the preclinical and clinical stage CMC development of all New Biologics Entities (NBEs) developed by Almirall. 
Biologics Development department responsibilities encompass developability assessment of lead candidates, cell line development, analytical and process development, formulation development, device development, DS/DP GMP manufacturing and support of regulatory filling. 
 

Tasks and Responsibilities

-    Lead the preclinical and clinical stage CMC development of NBEs with the direct management of a team of 4 technical people.
-    Provide input into antibody lead candidate selection and early profiling
-    Provide technical expertise for CMC development of NBEs, in particular for monoclonal and multispecific antibodies. 
-    Provide support for Due Diligences of NBEs projects
-    Ensure the set up and maintenance of an agile network of external partners for all the outsourced activities.
-    Ensure efficient progression of the NBEs projects in a highly collaborative and cross-functional environment.
-    Develop the team in CMC development of NBEs.
-    Ensure smooth transition of NBEs projects toward commercial manufacturing through frequent and close collaboration with Industrial Operations.

Education

PhD in relevant scientific area.

Experience

-    At least 15 years of experience in an industrial environment
-    Expert knowledge and track record as NBEs CMC development team leader  
-    In-depth knowledge in antibody profiling and manufacturing
-    Experience in multi-specific antibody and non-antibody modalities highly desirable
-    Strong leadership and experience working with external partner.