Upstream/Downstream Manufacturing

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: MondayFriday 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

Global Life Science Hub is a specialized Life Science headhunting firm. We place professionals across Europe and the US for various Biotechnology, Pharmaceutical, and CDMO companies, ranging from small start-ups to large global organizations.

If you're interested, please apply below. If this position doesn?t suit you, visit our website for more vacancieswww.glshub.com