Senior Fellow Early Translational Sciences (d/f/m)

Sandoz in Deutschland Holzkirchen

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Senior Fellow Early Translational Sciences (d/f/m)

Join to apply for the Senior Fellow Early Translational Sciences (d/f/m) role at Sandoz in Deutschland

Senior Fellow Early Translational Sciences (d/f/m)

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Join to apply for the Senior Fellow Early Translational Sciences (d/f/m) role at Sandoz in Deutschland

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!
Your Key Responsibilities
Your responsibilities include, but not limited to:

Represent Early Translational Sciences (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
Represent ETS in global cross-functional, clinical, technical (CMC) and scientific project teams and provide general pharmacology (Mode of action) expertise to assigned biosimilar programs from early strategic planning to post-approval. Design and execution of the functional characterization strategy.
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 ETS Laboratory
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
Collaboration with other ETS team members, and other functions such as Clinical Development , Reg. Affairs and external partners (CROs)

Essential Requirements
What you’ll bring to the role:

PhD with 8+ years relevant work-related experience incl. pharmaceutical industry experience
Excellent scientific and practical experience in development, qualification and validation of cell-based bioassays (incl. assays with primary cells) as well as bioanalytical techniques (e.g. ELISA, immunoassays, flow cytometry, microscopy)
Excellent knowledge in development and validation of potency assays incl. regulatory guidelines and requirements
Experience with the development of monoclonal antibodies incl. assessment of critical quality attributes (CQAs)
Excellent skills in presentation and scientific writing
Excellent English (oral and written), German is a plus

Desirable Requirements

Excellent knowledge of relevant software tools, e.g. PLA, SoftmaxPro, Knowledge in Bioassay statistics is a plus
Knowledge in structural biology / protein modeling and physico-chemical analytical methods is a plus

You’ll Receive
Sandoz has an employee-first approach and that’s why your personal growth is so important to us. You will have access to Coursera and other learning platforms with more than 200,000 learning videos and 5000+ courses.
In addition to the various learning opportunities, we offer company benefits, such as:

30 days of annual leave
Holiday allowance
Additional rewards for special occasions (e.g. service length awards, marriage celebration, etc.)
Company pension schemes and capital formation benefits
Parental leave
Other offerings, such as bike leasing

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, 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.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!
Join us!
Commitment To Diversity & Inclusion
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.