Senior Manufacturing Associate

Global Life Science Hub is proud to partner with a specialised Biopharmaceutical company leading the charge of next-generation drug delivery technologies and oral//biosimilar drug development.

Having gathered 2 recent FDA approvals, they're in the process of gearing up for exponential growth. With brand new in-house Manufacturing capabilities set to triple production in 2025, this is an exciting time to join a rapidly expanding organization.

To support further expansion, the Upstream Manufacturing Associate will be responsible for executing mammalian cell culture processes and producing proteins for a wide range of mammalian based biosimilars. The appointed candidate will require technical expertise in Cell Biology and Bioreactor Operations.

Responsibilities:

• Collaborate with a dynamic team of manufacturing associates and engineers to carry out upstream production batches.
• Conduct cell culture and manage bioreactor operations across various scales.
• Ensure the timely execution of engineering and clinical batches.
• Develop equipment specifications and enhance manufacturing processes.
• Utilize software to gather and analyze operational data for real-time product, instrument, or equipment adjustments.
• Interpret and follow instructions presented in written, verbal, diagrammatic, or schedule formats.
• Adhere to GMP guidelines in the manufacturing area and take the initiative to comply with environmental health and safety protocols.
• Review completed manufacturing and packaging batch records, along with related supporting documents.
• Lead the investigation and resolution of issues identified during batch execution.
• Perform additional duties as required or assigned.
• Adhere to all company policies and standards.

Requirements:

• Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences with a minimum of 3+ years of relevant experience in the biopharmaceutical sector.
• Proficiency in independently planning, executing, analyzing, and documenting all phases of process development.
• Strong foundational knowledge and expertise necessary to manage engineering and clinical batches.
• Previous experience in GMP and aseptic manufacturing settings.
• Must have Scale-Up Bioreactor experience
• Upstream cell culture process is required, CHO cell is highly desirable
• Familiarity with single-use manufacturing consumables, including bags, tube sets, columns, and process manifolds.

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