Scientist, Microbiology

Xellia Pharmaceuticals - Raleigh, NC (30+ days ago)3.4


Scientist, Microbiology or Associate Scientist, Microbiology
Quality

POSITION SUMMARY

This position serves as a technical expert for the functional area to which they are assigned, answering microbiological questions and providing guidance in the absence of supervision for both production and quality personnel.

This position reports to the QC Manager and has no direct reports. The Scientist position works closely with other departments, such as Operations, Validation, Technology Transfer, and Quality Assurance, to assure the support of the Microbiology department on various projects, studies and routine tasks.

The individual holding the position of Scientist shall have technical expertise in one or more of the functional areas of the laboratory. They may be responsible for completing routine analyst tasks such as environmental monitoring but this position is predominately academic. They will be responsible for acting as Supervisor in the absence of the supervisor as well as representing the Microbiology department at internal meetings and/or meetings with contract testing laboratories or consultants. Must be available to work overtime, as necessary.

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

Develops new Standard Operating Procedures for microbiology test methods, procedures and processes.
Responsible for Microbial identification.
Monitors and tracks laboratory results.
Trains new department personnel in SOP.
Provides validation test support.
Performs environmental monitoring and routine testing of in-process and finished products..
Performs routine analysis related to the testing and release of Raw Material, In-Process Finished Product, and Stability.
Assist with the execution of equipment and method validation.
Reviews data generated by QC technicians
Assists in compiling data for Annual Reports.
Assumes additional duties and responsibilities as assigned.

REQUIREMENTS

  • B.S. in Biology or Microbiology with 2 years experience preferred.
  • Associate's degree with 5+ years of experience
  • Bachelor’s degree (non-biological science) with 3 years experience
  • Excellent Verbal and Written communication skills are essential.
Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.
Read more about Xellia Pharmaceuticals here