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Senior Manufacturing Associate

Global Life Science Hub

Piscataway, new jersey


Job Details

Full-time


Full Job Description

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

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