Website Pharma Universe
Pharma Universe
Company : Pharma Universe
The Upstream Manufacturing Scientist is responsible for carrying out mammalian cell culture processes and producing recombinant proteins for a variety of mammalian-based biosimilars. This role involves executing cell culture batches ranging from 50 L to 1000 L for engineering and clinical purposes within a cGMP environment. The position requires expertise in bioreactor operations, cell biology, and proficiency in initiating batch records, protocols, investigations, and other technical documentation.
Essential Duties & Responsibilities
Work with a collaborative team of manufacturing associates and engineers to execute upstream batches.
Perform cell culture and bioreactor operations at multiple scales.
Ensure that engineering and clinical batches are executed in a timely manner.
Establishes operating equipment specifications and improves manufacturing techniques.
Uses programs to collect and evaluate operating data to conduct on- line adjustments to products, instruments or equipment.
Ability to interpret and provide instructions furnished in written, oral, diagram, or schedule form.
Should follow GMP instructions in the manufacturing area and take the lead to follow environmental health and safety policies.
Review executed manufacturing and packaging batch records, executed and associated supporting documents.
Coordinate the conduction of investigations and corrections for issues found during the batch execution process.
Education and Experience
Requires a Bachelor or Master’ degree in chemical, biological or biochemical sciences and a minimum of 3+ years of related experience in the biopharmaceutical industry.
Expertise in independently conducting and directing the design, execution, analysis, and documentation of all states of process development.
Strong fundamental knowledge and subject matter expertise to execute engineering and clinical batches.
Previous experience working in GMP and aseptic manufacturing environment.
Experience working with single use manufacturing consumables such as bags, tube sets, columns and process manifolds.