Global Biosimilar Analytical Methods Development Lead


Job description:

Teva R&D is looking for a senior talent to lead the Biosimilar Analytical Methods Development team and its activities.
Primary purpose and function of this position is to lead and manage the analytical team on the physicochemical characterization of biological drugs and on the development of analytical methods to support cell line and process development yielding high quality Biosimilar candidates.

Major duties and responsibilities:
• To guide the analytical development and lead the team in planning and achieving the departmental and Biosimilars unit goals.
• To be updated on relevant scientific and technological developments in the bioanalytical field through literature and meetings in order to implement innovation, improve efficiencies and build deep product knowledge.
• To write and review documents (e.g. SOPs, development reports, rationale, sections for regulatory submissions).
• To foster an environment of professionalism, innovation, creativity, synergy and good communication within the analytical department, with other Biosimilar departments as well as with other units (QA, RA, CMC Biologics, etc.).
• To manage, guide and mentor the second line managers in the analytical department.
• To be part of the management team and represent the analytical department in project planning, updates on activities, budget planning, troubleshooting, cross functional and cross-organizational teams.
• Be on top of current regulations in the field of Biosimilars.
• Support submissions and correspondences with regulatory authority.

Required qualifications:

Ph.D in life sciences / biotechnology and vast experience in the relevant field
Deep understanding in proteins structure and mainly in the structure and function of monoclonal antibodies
Proven experience and knowledge in analytical methods development for glycoproteins (HPLC/UPLC, electrophoretic methods, mass spectrometry, characterization of high order structure)
At least 10 years of proven experience leading/managing analytical teams
High knowledge in GLP/GMP guidelines
Good knowledge of Office software, and of Statistical tools
Fluent in Hebrew & English- reading and writing
Residence near Netanya – preferred

Job location

Netanya, Israel