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 in a cleanroom environment at level 3 gowning with moderate noise levels from HEPA filtration. 

Physical demands: 

• Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly. 

• Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds. 

• Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.  

• Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder. 

• Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).  

• Pushing - Exerting force upon an object so that the object moves away from the object. 

• Pulling - Exerting force upon an object so that the object moves toward the force.  

• Sitting – remaining in a sitting position for at least 50% of the time. 

• Standing/Walking - remain on one's feet in an upright position at a workstation.  

• Stooping – occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles. 

  Travel required: Less than 10%, minimal 

Required education and experience: 

•   BA or BS in any science related field 

• Minimum of 5 years experience in a regulated laboratory environment 

Preferred education and experience: 

• BA or BS in Biology, Biological Sciences, Microbiology, Biochemistry, or Biomedical Science/ Engineering. 

• Contain laboratory skills including microscopy, visual inspection, sterility, endotoxin, mycoplasma, and microbial identification. 

• Experience in environmental monitoring programs for the support of drug product manufacture. 

• Experience in writing assay qualifications, deviation reports, standard operational procedures, laboratory investigations, corrective actions and change controls.