Viral Safety Intern

Job Description

What we do in BioPharma Biosafety

Biosafety is an important part of manufacturing biological therapies.  The manufacturing process includes the use of bioreactors with enriching media to encourage cell growth and the production of proteins, vectors, and other therapeutic agents. Due to the nature of the manufacturing process and the biologically based raw materials, undesirable contaminants such as bacteria, mycoplasma, and viruses must be monitored.  Biosafety provides analytical services to support the cell line used in biologics manufacturing and to ensure that the product is virus-free.

Center of Focus & Testing Techniques

Several departments make up Biosafety:

• Cell Banking- supports the creation of cell banks, analytical testing including cell line characterization testing is performed in other areas after expansion.
• Viral Safety- utilizes platform cell-based methods to determine presence/absence of viral contaminants in cells, raw materials and final products.
• Transmission Electron Microscopy- is utilized to collect images of cell lines and process manufacturing intermediates to determine and/or quantify viral presence.  If viral presence is determined, the titer of virus defines the process clearance required in the finishing steps.
• Viral Clearance- lab-scale processing steps are used to determine how successful the viral inactivation/reduction/clearance is for a particular step using representative virus spikes. The processing steps may include chromatography, pH inactivation, and filtration. 
• Cell & Gene Therapy- performs analytical testing in support of viral vectors and cell therapy products to provide data regarding purity, impurities, infectivity/performance, concentration, and safety of samples.  Several molecular based techniques such as PCR, ELISA, Flow cytometry, and cell counting are used.
• Next Generation Sequencing- sequencers are used to monitor biological materials to report identity and purity. NGS is useful in determining the identity of biological contaminants in samples. MiSeq and NextSeq instruments are used.

Familiarity with cell culture, chromatography, molecular instrumentation, virus stocks, and BSL2 will be advantageous to applicants.

Intern Experiences include:

• Opportunities to shadow all levels of staff in multiple areas of Biosafety.
• Exposure to biological testing and techniques and why they are relevant to the industry.
• Hands-on experience may be available through non GMP laboratory activities.
• Documentation and basic GMP regulations will be highlighted.
• Lab management tasks, maintenance and organization of space and equipment may be assigned.

Qualifications

Intern Responsibilities, Skills & Qualifications include:

• Performing tasks independently following training.
• Time management and initiative are expected for any recurring assignments.
• Understanding and adherence to the safety guidelines for lab work is a requirement.
• Attention to detail with the ability to follow and apply work procedures is expected.
• Additional requirements: Technical writing, Presentation skills, public speaking
• Intern will be required to provide a 30-minute presentation (15-minute Q&A) following the conclusion of the internship experience. Representatives from Eurofins will be invited.

Minimum Qualification: Must have completed your sophomore year and be majoring in a relevant scientific field.