Bioprocess Expert

Global Life Science Hub

We are excited 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 soon, they're expanding and renovating their facility to scale up production from 50L to 2000L.

$120,000 - $150,000 per year (dependent on experience). We offer competitive benefits, including health insurance, retirement plan, and paid time off.

As an Upstream Process Development Specialist at our client's New Jersey facility, you will be responsible for leading mammalian cell culture and bioreactor operations. You will play a pivotal role in driving the company's next phase of growth by optimizing bioreactor performance, developing and refining operating equipment specifications, and working collaboratively with a team of manufacturing associates and engineers.

• 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 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.

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.