Downstream process development group manager For a global pharmaceutical company

The group specializes in developing downstream processes, to provide protein of the appropriate quality with high yield, in a process that is manufacturing friendly. The Group works in full cooperation with other groups in the development of protein production and analytics, other departments in the local organization: manufacturing, QC/QA maintenance, engineering, and cooperation with other sites around the world.

Responsibilities:

• Responsible for development of protein purification processes in various systems - Chromatography, UF/DF, filtration, precipitation, continuous well as batch process

• Management of about 8-10 scientists and technicians.

• Identification, development and adjustment of advanced relevant technologies

Requirements

• PhD in Biotechnology Engineering / Biochemistry / Life Sciences

• 5 years of experience in the pharmaceutical industry, and at least 3 years in management (scientists and technicians).

• Experience in GMP manufacturing-advantage

• Experience and proficient in process validation, process upscaling and technological transfer, support for clinical batch manufacturing.

• Experience in executing and submitting CMC development, DSP Development in accordance with regulatory requirements. continuous process and PAT development - an advantage

• Writing development reports and submission chapters (CTD) responsible for planning, Gantt, budget management and updating management.

• Good understanding of pharmaceutical regulation

• Proficiency in statistical tools in experimental design and analysis (use of DOE-advantage tools)

• Willingness to support extended hours as needed.

• Excellent communication ability.

• Corporate Responsible – Safety – GMP compliance.

  To submit a resume, please:https://app.civi.co.il/promo/id=700857&src=7120