Job Title: Quality Control Specialist I - HPLC  
Location: Houston Headquarters’ Facility  
Department: Quality Control & Analytic Development  
Reports To: QC Scientist  
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 is 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.

Overview

As our business grows quickly, we are looking for a qualified Quality Control Associate to undertake laboratory works under the guidance of senior scientists. The Quality Control Associate will have chance to learn a variety of molecular and cellular laboratory techniques, including cell culture, DNA extraction, solution preparation, etc. 

General Responsibilities:

The Quality Control Specialist I  or II- HPLC will undertake laboratory work under the guidance of senior scientists. The Quality Control Specialist I or II is responsible to operate and maintain HPLC instruments; execute HPLC assays. The Quality Control Specialist I will have chance to learn Gene Therapy concepts and cGMP practice, etc 

• Conduct experiments under defined protocols under supervision of QC/AD scientist.  
• Routine lab activities may include
• Prepare solutions, buffers, and reagents.
• Execute analytical assays on HPLC instruments. Perform HPLC instruments maintenance. 
• Effectively plan lab activities by ensuring equipment readiness and reagents availability. 
• Order lab reagents and suppliers and monitor expiry of critical raw materials.  
• Maintain an accurate sample inventory.
• Record all data and results following good documentation practices. 
• Collaborate closely with cross functional teams to ensure timely receipt and testing of samples.  
• Coach and train staff as needed. 
• Maintain clean working lab environment.
• Revise, format documentation and study reports.
• All other duties as assigned  

Working conditions

In laboratory 

Qualifications

• Bachelor’s Degree in Biological science or related field.
• Experience working in a cellular or molecular biology laboratory is preferred.
• Working knowledge of cell culture, AAV and experience with GxP-based laboratory setting and regulatory guidance is a plus.
• Strong Interpersonal skills.
• Strong problem-solving abilities and drive for success.
• Excellent written and oral communication skills. 
• High level of self-motivation. 
• Keen attention to details. 
• Extensive experience working in a team-oriented, collaborative environment. 

Physical Qualifications: 

• Mobility in facility.
• Ability to lift up to 45lbs.
• Visual and hearing abilities with or without correction.
• Sitting and standing for extended periods of time. 
• All other duties as assigned.