What are the responsibilities and job description for the Bioprocessing Specialist (Upstream) position at Pharma Universe?
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.
Responsibilities:
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.
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
- 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
