Downstream Manufacturing Assocaite

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 in New Jersey as they ramp up production efforts from 50L to 2000L in Q4.

To support further expansion, we seek a Downstream Manufacturing Associate responsible for purifying clinical and commercial batches in a cGMP environment. This position requires technical expertise in AKTA purification skids or similar, TFF, knowledge of initiating batch records, and experience packing chromatography columns.

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

Experience/Qualifications:

• A BSc or MSc in a life science sector
• A minimum of 3 years’ experience in downstream processing
• Previous experience within in an Aseptic Manufacturing environment
• Experience running Chromatography systems and packing columns
• Ability to run TFF operations
• Experience working with AKTA process skids and knowledge of unicorn software is highly desirable
• 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 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