Senior Fellow Ets - Munich, Deutschland - Hexal AG

Hexal AG

Geprüftes Unternehmen

Munich, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

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 lifecycle management of binding and cellbased 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 crossfunctionally, 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 onboarding 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 / inlicensing 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
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

What you'll bring to the role:

Essential Requirements:

PhD with 8+ years relevant workrelated experience incl. pharmaceutical industry experience
Excellent scientific and practical experience in development, qualification and validation of cellbased bioassays (incl. assays with primary cells) as well as bioanalytical techniques (e.g. ELISA, ECL immunoassays, flow cytometry, luminescence, microscopy)
Excellent knowledge in development and validation of potency assays incl. regulatory guidelines and requirements
Excellent knowledge of biosimilar development incl. regulatory requirements, guidelines and expectations
Experience with the development of monoclonal antibodies incl. assessment of critical quality attributes (CQAs)
Excellent skills in presentation and scientific writing
Experience with working in a regulated environment
Previous industry experience in biotherapeutic drug development in a global matrix environment
Excellent knowledge of relevant software tools, e.g. PLA
Leadership experience is a plus
Experience in Design of Experiments (DoE) and lab automation is a plus
Knowledge in structural biology / protein modeling and physicochemical analytical methods is a plus
Excellent English (oral and written), German is a plus

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

The future is ours to shape

Commitment to Diversity & Inclusion:

We are committed to building an outstandin