Manufacturing Scientist

Global Life Science Hub is partnered with an innovative biopharmaceutical company specializing in difficult-to-formulate biologics in the Oncology and Infectious Disease fields. Recently, the company has achieved a significant FDA approval 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.

We require a Downstream Manufacturing Scientist to work on-site in New Jersey and will be responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian biologics. This position requires technical expertise in AKTA purification skids or similar, TFF and knowledge of initiating batch records, protocols, investigations and other technical documents.

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:

• 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.
• Special Skills:
• Ability to work with other team members and independently - good interpersonal skills.
• Good communication skills: verbal and written, good computer and organization skills, detail oriented.
• Basic computer skills, including knowledge of Word, Excel and spread sheet
• Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
• Knowledgeable in cleaning verification/validation. 

Apply:

The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com