Για εργοδότες
Biotech Upstream Process Development Manager
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501-2000
Φαρμακευτικές & Κλάδος Υγείας
ΑθήναΤοποθεσία
Αθήνα
πριν 13 μέρες
Ημ. ανάρτησης
πριν 13 μέρες

At DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are excited to kick-off our Biotechnology project in Athens.

The field of Biotechnology is bringing about fascinating developments in medicine, treatments, and healthcare, as new, effective medicines are being produced from extremely complex natural compounds, with a biological origin. Demo leads the way in the Greek pharmaceutical market with major investments in Biotechnology;

·         We are building a prototype unit for the development of monoclonal antibodies

·         We are creating a contemporary Research and Development Center for biotechnology

·         We are starting research for three finished pharmaceutical products with monoclonal antibodies

·         We are establishing a Biotechnology Academy to train young scientists. Biotechnology is becoming part of our lives.

As a result, we are currently looking for a high caliber USP Manager

Main duties and responsibilities:

·         Build and implement a strategy for the USP and USP-production division in the R&D Biotechnology department

·         Follow and implement EU and US regulations regarding all aspects related to the process deliverables and their quality requirements with an emphasis on biosimilars development Monitor productivity of laboratories.

·         Setup and supervision of the use and maintenance of the USP infrastructure required for USP and for BIO Academy purposes

·         Supervision of development projects regarding USP development strategy, deliverables, timelines etc.

·         Manage Process development scientists and Laboratory schedules to account for priority changes and project status. Interact with all R&D teams to consolidate schedules

·         Actively participate in tech transfer and process development activities

·         Ensure USP development laboratories are compliance to EMA and FDA requirements

·         Identify and lead continuous improvement opportunities relating to the manufacturing process



Requirements

·         MSc in Biology, Biotechnology, Chemistry or related field

·         PhD degree in a field related to biotechnology, bioengineering, biochemistry, or molecular biology will be highly appreciated

·         Minimum 8-10 years of experience directly in USP within a biotech or pharmaceutical company, plus at least 3 years’ experience in leading teams

·         Good understanding of regulations required for USP development of biotech products, preferably in monoclonal antibody development

·         In-depth knowledge of the development, scale-up and implementation of Upstream applications and technologies

·         Strong background and hands-on experience in Upstream processing of biotherapeutics (biosimilars and monoclonal antibodies preferred)

·         Ability to motivate, lead, coach and develop people

·         Strong problem solving attitude and ability to work independently

·         Project management skills with focus on deliverables, quality and timelines

·         Design of Experiments experience is required with a strong background in process characterization

·         Excellent communication skills both verbal and written



Benefits

The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.

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Biotech Upstream Process Development Manager
Αθήνα
πριν 13 μέρες
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