Manufacturing Scientist (USP) - Newark
Global Life Science Hub is thrilled to partner with a biologics powerhouse on the brink of exponential growth! With 2 commercial products already on the market and a third approval expected any day, they’re expanding and renovating their New Jersey facility to scale up production from 50L to 2000L.
We’re kicking things off by hiring 3x dynamic on-site Upstream Scientists to lead mammalian cell culture and bioreactor operations. You’ll be at the forefront of recombinant protein production in a cGMP environment, playing a pivotal role in driving the company’s next phase of growth.
Responsibilities:
- Optimize bioreactor performance and scale-up procedures to meet production goals and maintain product quality.
- Develop and refine operating equipment specifications and implement improvements to upstream manufacturing techniques.
- Work collaboratively with a team of manufacturing associates and engineers to execute upstream batches efficiently.
- Establish and refine operating equipment specifications to enhance manufacturing techniques.
- Interpret and communicate instructions in various formats (written, verbal, diagrammatic) to ensure clarity and compliance.
- Follow GMP guidelines and lead efforts to maintain environmental health and safety policies in the manufacturing area.
- Review executed manufacturing and packaging batch records along with supporting documents for accuracy and compliance.
- Coordinate investigations and corrective actions for any issues identified during the batch execution process.
- Perform additional functions as required to support team objectives and compliance with all company policies and standards.
Experience/Qualifications:
- 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.
- Familiarity with single-use manufacturing consumables, including bags, tube sets, columns, and process manifolds.
Apply
Global Life Science Hub is a specialized Life Science headhunting firm. We place professionals across the United States and Europe for various Biotechnology, Pharmaceutical, and CDMO companies, ranging from small start-ups to large global organizations.
If you’re interested, please apply below. If this position doesn’t suit you, visit our website for more vacancies – www.glshub.com