Manufacturing Scientist (Third Shift)

Global Life Science Hub is partnered with an incredible biopharmaceutical company specializing in difficult-to-formulate biologics. Recently, the company has achieved 2 FDA approvals and is transitioning from R&D to a full-scale commercial organization looking to build a new state-of-the-art facility as they ramp up production efforts from 50L to 2000L. We seek a 3x Manufacturing Scientist for... the 3rd shift to support further expansion. The appointed candidate will participate in the cGMP manufacturing processes, technology transfer, and author/revise documents to support batch records. The candidate will also prepare production systems, buffers, and media for use in the production area. Shift Hours: Monday - Friday 22:00 to 06:00am Location: Piscataway, New Jersey Responsibilities: • Writes and reviews SOPs • Provide support to Quality and Compliance Departments during regulatory audits • Accomplishes small projects independently and provides substantial assistance to large projects • To monitor bioreactor operation (70 % of the total night shift) • Support media or buffer preparation • Support Downstream process (cleaning of column, sampling etc.) • Logbook verification and document review • Participate in the cleaning activities of the routine items as per cleaning validation program • Process data compilation • pH / conductivity meter, osmometer and scale calibration / verification Experience/Qualifications: • Masters or Bachelor degree in Chemistry, Biology, Biochemistry or related field • Relevant experience in a Biopharmaceutical organization • Experience and knowledge in drug substance manufacturing (Fermentation and protein purification) and in drug product manufacturing (aseptic processing areas) • Upstream or downstream background • Must have worked in biologics for at least 2 years Apply: The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you're interested, please apply below. If this position doesn't interest you, please visit our website for a list of more vacancies - www.glshub.com Apply Job!