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Sr Engineer, Mfg Science Drug Substance

Auris Health

Auris Health

Bern, Switzerland
Posted on Tuesday, August 8, 2023
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Description

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Janssen Vaccines, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide. The Bern site acts as a center of expertise for development and manufacturing of innovative cell based viral- and bacterial vaccines and is recently expanding its portfolio into bacterial based therapeutic products.

Main Responsibilities:

The aim of the position is to support the CAR-T R&D project to support a routine GMP manufacturing process with focus on Downstream process steps (Clarification, AEX chromatography, TFF)

● Support routine GMP manufacturing and help in trouble shooting

● Managing of Quality Issues, Root Cause Analysis and Investigation

● Data verification

● Data trending

● Initiating and implementing of Change Controls

● Support Compliance team with SOP, WIs, Job aids harmonization initiatives across site

Qualifications

Who we are looking for:

● Master or Bachelor degree in Bio-Engineering / Biotechnology / Biology / Biochemistry

● Several years experience in GMP compliant biotechnological manufacturing or development

● Experience in different downstream process such as AEX chromatography, TFF (Ultrafiltration/Diafiltration), clarification steps

● Excellent problem solving and analytical capabilities

● Knowledge in Python and Statistic

● Team player and a personality with excellent interpersonal communication skills

● Capacity to communicate fluently in English and German