Quality Control Microbiology Specialist II

About the position

PackGene is looking for highly motivated individuals to join our growing Houston site to support gene therapies CDMO GMP manufacturing. The Quality Control Department at PackGene Biotech is seeking a talented individual for a Specialist role in QC Microbiology. The Microbiology Specialist will play a leading role in micro testing and environmental monitoring data analysis. Therefore, the ideal candidate needs to bring experience in microbiology and its applications within a cGMP production with familiarity with regulatory requirements for microbiological testing for cGMP product release.

Responsibilities

• Evaluate QC Microbiology activities.
• Responsible for testing and monitoring.
• Participate in the environmental monitoring program and follow related established procedures.
• Oversee the microbiology laboratory.
• Manage the media and microbe qualification testing in support of EM and/or (Bioburden) sterility testing.
• Develop study designs, data/statistical analysis, reporting results in both written and oral format (presentation).
• Responsible for QC Micro material, 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, and with Procurement, Manufacturing and Quality Assurance.
• Problem solving and troubleshooting Microbiology assay as necessary.
• Other duties as assigned.

Requirements

• B.S. or MS 2-4+ yrs. or Ph.D. in relevant field.
• Knowledge of ISO regulations specific to GMP cleanrooms and a good understanding of USP, EP guidelines associated with cell and gene therapies/ 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.).
• Experience in plating, reading and reporting results, microbial identification, identification of EM excursions, and trending.
• 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.
• 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.
• Ability to solve problems and troubleshoot as necessary.