Global Life Science Hub is partnered with an innovative biopharmaceutical company specializing in difficult-to-formulate biologics.
Recently, the company has achieved 2 FDA approvals and is now transitioning from R&D to a full-scale commercial organization.
With a highly robust pipeline of advanced assets and expected approvals lined up until 2030, the company is positioned for significant growth.
To support further expansion we seek a Downstream Processing Scientist who is responsible for the purification of 50L to 1000L volumes engineering, clinical and commercial batches in a cGMP environment.
This position requires technical expertise in AKTA purification skids or similar, TFF and knowledge of initiating batch records, protocols, investigations and other technical documents.
Essential Duties & Responsibilities
Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
Provides technical direction in the execution and development of the purification process.
Uses programs to collect and evaluate operating data to conduct on- line adjustments to products, instruments or equipment.
Ensure that engineering and clinical batches are executed in a timely manner.
Establishes operating equipment specifications and improves manufacturing techniques.
Works with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment.
Should follow GMP instructions in the manufacturing area and take the lead to follow environmental health and safety policies.
Coordinate the conduction of investigations and corrections for issues found during the batch execution process.
Performs other functions as required or assigned
Complies with all company policies and standards
Requirements
Requires a Bachelor or Master’ degree in chemical, biological or biochemical sciences and a minimum of 4- 5 years of related experience in the biopharmaceutical industry.
Previous experience working in GMP and aseptic manufacturing environment.
Experience working with AKTA Process skids or similar and familiarity of single use manufacturing consumables such as bags, tube sets, columns and process manifolds.
Possess knowledge to execute engineering and clinical batches; familiar with GMP documentation.
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 CRO 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
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