Senior Fellow ETS - Holzkirchen, Deutschland - Novartis

Beschreibung

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates.

This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our 'new' Sandoz

Your Key Responsibilities:

Your responsibilities include, but not limited to:
Represent ETS esp. regarding bioassay topics for assigned projects internally and externally and provide scientific input to the nonclinical in vitro strategy / functional characterization with special focus on feasibility and specificities of assay development (in close alignment with ETS Managers and Lab Heads) as well as strategic planning activities
Provide strategic input for development, qualification, validation, assay transfer and life-cycle management of binding and cell-based bioassays incl. troubleshooting, in close consultation with the Head Laboratory Operations ETS
Provide biosimilar bioassay expertise for in vitro functional characterization and bioassay strategy and ensure an integrated assessment of in vitro bioassay data
Support preparation and review of scientific and international registration documents; support interaction and communication with health authorities, responsible to respond to bioassay related questions, e.g. list of questions (LoQ) and requests for information (RFI) (in close alignment with ETS Managers and Lab Heads, as needed)
Ensure compliance to internal and external guidelines regarding quality (Quality Manual, SOPs, regulatory guidelines), safety (HSE, biological safety, worker safety) and information security (ISEC)
Ensure efficient knowledge building in the field of bioassays esp. for biosimilar development within ETS and cross-functionally, following closely industry and regulatory trends and keep up to date regarding new regulatory guidelines
Serve as peer coach for new Lab Heads and ETS Managers for effective on-boarding into role
Excellent communication to ETS team members, associates, supervisor other functions within Biopharma Technical Development (BTD), Global Clinical Development (GCD), Reg. CMC, Reg. Affairs and external partners (CROs)
Can represent the function in Due Diligence / in-licensing activities
Can serve as a Laboratory Head ETS with direct reports
Can serve as the line function head deputy of the Head Laboratory Operations ETS and is a mentor for less experienced Lab Heads / Scientists, ETS Managers or colleagues from other line functions with respect to requirements of bioassay development of biosimilars