USP Bioprocessing Specialist III

The role will involve performing upstream manufacturing to ensure that the process is robust, scalable, and successfully executed in the manufacturing facility – as well as the accompanying documentation. The successful candidate will be familiar with cGMP regulations and technology transfer tasks and work out of the brand-new state-of-the-art facility in New Jersey, USA.

This position requires great attention to detail, the ability to work in a team environment, and a keen interest in the optimization of processes. Scientists will be responsible for adhering to all Quality Management System procedures, safety policies, and relevant parts of cGMP.

Location: On-site, USA - New Jersey

Type: Full-time

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.