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!