Downstream Process Development Group Manager

Job description

Downstream process development group manager

General

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.

Job description

• 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.

Job 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.