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Upstream Manufacturing Scientist

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Global Life Science Hub

2024-10-05 17:44:18

Job location Piscataway, New Jersey, United States

Job type: fulltime

Job industry: Manufacturing Operations

Job description

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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