Manufacturing Scientist
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 www.glshub.com
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