Demo

Upstream/Downstream Manufacturing

Global Life Science Hub
Jersey, NJ Full Time
POSTED ON 12/24/2024
AVAILABLE BEFORE 4/22/2025
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

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 vacancies - www.glshub.com

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