Senior Microbiologist

FLSA Classification : Exempt/Salary 

Schedule: Monday – Friday; 0800 - 1730 

Department: Quality Control  

Reports to: Associate Director, Microbiology Quality Control 

Supervisory responsibilities: No 

Location: 13203 Murphy Rd. Suite 100, Stafford, TX 77477 

Position Summary/objective: 

The main role of the Senior Microbiologist is to provide oversight of the microbiology laboratory for the execution of assays and assay qualifications for support of the environmental monitoring/ microbiology department and final product testing. 

Essential functions: 

• Author study protocols and perform matrix verifications per USP and EP guidelines for rapid sterility. 

• Manage and perform microbial media release testing through growth promotions. 

• Coordinate and perform microbial identifications and organism retention. 

• Design and write study reports and discrepancy reports to establish assay matrix qualifications. 

• Design, write, and execute limit of detection studies for the rapid sterility platform. 

• Plan and coordinate various qualification studies for the support of the environmental monitoring program. 

• Oversee microbiological equipment validations, maintenance, and calibrations. 

• Assist in aseptic process simulations. 

• Write and revise standard operating procedures and laboratory investigations. 

• Direct contamination investigations and assist in environmental excursion investigations  

Secondary functions: 

• Train junior analysts. 

• Assist with group task scheduling. 

• Able to substitute for environmental monitoring specialists and perform EM duties when required. 

 Competencies:  

• Work independently 

• Initiative 

• Problem Solving 

• Strong communicator and collaborates effectively with coworkers and between departments. 

• Flexible and able to work under pressure and meet project timelines 

Work environment: 

• This position works in a typical office and laboratory environment with moderate noise levels and uses phone, computer, office equipment, and supplies on a regular basis.  

• While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, fumes or airborne particles, pathogens, and toxic or caustic chemicals. The employee can be occasionally exposed to wet and/ or humid condition, risk of electrical shock, sharps or cuts while performing tests. 

• This position requires the handling of human biological specimens including human peripheral blood and human T cell products, as well as laboratory chemicals. 

• This position can work i