Senior Analyst, Supervisor, Manager QC Microbiology

Description

Job Title: Senior Analyst, Supervisor, Manager QC Microbiology

Location: Houston Headquarter Facility

Department: Quality Control

Reports To: Associate Director Quality Control

FLSA Status: Full Time/ Exempt

Mission Statement

The mission of Packgene Biotech is to accelerate gene therapy product development by providing an integrated one-stop solution including plasmid, viral vector, fill-finish and QC analytical services for the gene therapy industry.

Company Background

Packgene Biotech was founded in 2014 and headquartered in Guangzhou China. It provides CRO/CDMO services to the emerging gene therapy industry and research institutes. Packgene Biotech (US) is a full subsidiary of the parent company and is expanding its global footprint to Houston TX.  

Packgene is looking for highly motivated individuals to join our growing Houston site and become leaders of the company.

The Quality Control Department at PackGene Biotech is seeking a talented individual for a leadership role in QC Microbiology. 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.). 

Requirements

• 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

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 guidelin