What are the responsibilities and job description for the Manufacturing Associate I/II/III (Third Shift) position at Global Life Science Hub?
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
