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Guarantee the development and validation of in vitro bioassays having the characteristics of reliabilities required by the qualitative standards of the company and in agreement to the relative Guidelines (ICH, EU/US Pharmacopeia), to support the activities of Quality Control and Development teams for NBE, Biosimilars and marketed products, consistent with the objectives established, cGMP and internal quality standard and high ethical commitment of the team. Automating in vitro bioassays using advanced robotics will be a key goal and responsibility.
Lead the team by managing the timelines and activity scheduling, ensuring full adherence with the budget.
Participate to key national and international meetings about the team activities.
Involved in drafting and revision of regulatory documents and directly interact with Health Authorities
Collect the results achieved providing the documentation necessary for the discussion with the partners and for the subsequent phases of the project.
People developer of a mid-size team
Who you are:
- PhD Biotechnology / Pharmacology or comparable experience in the field
- Specialization with 5+ years of experience in a Biotech Company in the field of analytical development of cell-based assay for biologics
- Strong knowledge on bioassay and potency validation
- Automation expert for cell-based assays
- Excellent knowledge of the principles of cell biology, biochemistry and cell culture techniques.
- GMP experience
- Adequate basic knowledge of Applied Statistics
- Fluent English is a key requirement
- Experience in people management is a plus
- Experience in CRO in the field is a plus
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com