Upstream Manufacturing Scientist
Global Life Science Hub
Piscataway, new jersey
Job Details
Full-time
Full 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.