Upstream Manufacturing Scientist

Global Life Science Hub Piscataway , NJ 08872

Posted 3 weeks ago

We at Global Life Science Hub are recruiting on behalf of a leading biopharmaceutical company for an Upstream Manufacturing Scientist. This is a full-time role, ideal for a professional with strong expertise in mammalian cell culture processes and bioreactor operations.

Position Summary:

In this role, you will be responsible for executing cell culture batches ranging from 50 L to 1000 L volumes, focusing on the production of recombinant proteins for mammalian-based biosimilars. You will work in a cGMP environment, ensuring that both engineering and clinical batches are executed efficiently and in compliance with regulatory standards.

Key Responsibilities:

  • Collaborate with a team of manufacturing associates and engineers to execute upstream batches.
  • Perform cell culture and bioreactor operations at multiple scales.
  • Ensure timely execution of engineering and clinical batches.
  • Establish equipment specifications and refine manufacturing techniques.
  • Collect and evaluate operating data, making necessary adjustments to products, instruments, or equipment.
  • Interpret and provide instructions across various formats (written, oral, diagram, schedule).
  • Lead GMP compliance efforts and adhere to environmental health and safety policies.
  • Review and coordinate the investigation of executed manufacturing and packaging batch records.
  • Perform additional duties as required.

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 industry.
  • Proven expertise in the design, execution, analysis, and documentation of process development stages.
  • Strong knowledge in GMP and aseptic manufacturing environments.
  • Experience with single-use manufacturing consumables (bags, tube sets, columns, process manifolds).

Skills:

  • Ability to work collaboratively and independently with strong interpersonal skills.
  • Excellent verbal and written communication skills, along with strong organizational abilities.
  • Basic computer proficiency, including Word, Excel, and spreadsheet management.
  • Familiarity with GMP batch manufacturing and packaging documentation, as well as cleaning verification/validation.

If you have a strong background in bioreactor operations and are ready to take on a new challenge in a dynamic and collaborative environment, we encourage you to apply.

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