Quality Control Microbiology Supervisor

Description

Job Title: Quality Control Microbiology Supervisor

Location: Houston Headquarter Facility

Department: Quality 

Reports To: Senior Director, Quality

FLSA Status: Full Time/ Exempt

Job purpose

The Quality Control Department at PackGene Biotech Inc is seeking a talented individual for a leadership role in QC Microbiology Supervisor. The leadership role will be commensurate with the experience and skills of the selected candidate at the Senior Analyst, Supervisor or Manager level. The Microbiology Leader will be a subject matter expert with excellent troubleshooting, training, and presentation skills. At its core, the position requires a strong working knowledge and experience in microbiology and its applications within a cGMP production facility. Another requirement of the position is familiarity with regulatory requirements for microbiological testing for cGMP release of Biologics. Knowledge of compendial microbiological safety testing methods and requirements common to the pharmaceutical industry for bioburden & sterility, mycoplasma, endotoxin, etc., and experience with culturing and identifying various microorganisms (bacteria, yeast, fungi) by different methods (stains, PCR, etc.).  

Duties and responsibilities

• Evaluate all Quality Control Microbiology activities. 
• Responsible for Managing/scheduling staff for testing and monitoring. 
• Participate in all the environmental monitoring program. 
• Oversee the microbiology laboratory including, set-up/equipping, and inventorying.  
• Review and execution of state-of-the-art methodology for rapid detection of microbial contamination and/or identification (MycoSeq qPCR-based mycoplasma detection assays and validation of such methods according to pharmacopeial (e.g. EP) guidelines, etc.).  
• Manage the media and microbe qualification testing in support of EM and/or (Bioburden) sterility testing.  
• Develop the study design, data/statistical analysis, reporting results in both written and oral format (presentation).  
• Responsible for QC Micro product/material stability, data review, data trending, comparability, qualification/validation, compendial methods, etc.  
• Be able to draft Standard Operating Procedures (SOPs), protocols, reports, environmental monitoring excursions, OOS, investigations, etc.  
• Responsible for intra-departmental and inter-departmental collaboration and communication within QC-A, and with Procurement, Manufacturing and Quality Assurance.  
• Problem solving and troubleshooting Microbiology assay as necessary.  
• Other duties as assigned 

Requirements

Skills and Qualifications

• Knowledge of ISO regulations specific to GMP cleanrooms and a good understanding of USP, EP guidelines associated with cell and gene therapies/ biologics.  
• Experience in CAPA and troubleshooting.  
• Ability to process large amounts of documentation in a timely and efficient manner.  
• Team-oriented, multidisciplinary, and multicultural environment.  
• Able to work flexible hours to meet “deliverable” deadlines.  
• Desire to take initiative on department-wide improvement projects and drive them to completion. 
• Experience with media and microbe qualification testing in support of EM and/or (Bioburden) sterility testing.  
• Experience with qPCR-based mycoplasma detection assays and validation of such according to pharmacopeial (e.g. EP) guidelines.  
• A detailed understanding of cGMP/GLP regulations as well as excellent cGDP skills to facilitate the completion of all Quality Control activities.  
• Familiarity with basic core QC areas including product/material stability, data review, data trending, comparability, qualification/validation, compendial methods, etc.  
• Excellent writing skills and experience in drafting Standard Operating Procedures (SOPs), protocols, reports, environmental monitoring excursions, OOS, investigations, etc.  
• Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies in general and the environmental monitoring and operation of cleanrooms, specifically.  
• Excellent interpersonal skills and willingness to work interdepartmentally with QC, Manufacturing and Quality Assurance.  
• Previous training experience and excellent presentation skills.  
• Ability to problem solve and troubleshoot as necessary.  

Education and Experience

B.S. or MS 4-6+ yrs. Ph.D. in relevant field 

Working conditions