Quality Control Specialist II

Description

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.

Overview

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

General Responsibilities:

• Conduct assays under defined protocols with minimal supervision from a senior scientist.  
• Handling variety of equipment and their IOQ execution and maintenance including but not limited to qPCR, ddPCR      instruments, plate readers, Gel documentation imagers, pH meters, Osmolality instrument, and Cell counters etc.
• Experience in executing ddPCR, qPCR, ELISA and cell culture-based assays and qualification activities following protocols      on AAV samples.
• Experience in drafting SOPs, test methods, reports and protocols as needed.
• Routine lab activities may include:  
• Prepare solutions, buffers, and reagents.  
• 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.  
• Package final product and samples for shipment.       
• Arrange shipping of materials and proactively tracking of shipments.  
• Coach and train staff as needed.  
• All other duties as assigned 

Requirements

Qualifications

• Bachelor’s Degree in Biological science or related field.
• 2~4 years’ experience working with gene therapy operation 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. 

Working conditions

• In laboratory  

Physical requirements

• Crouching: Bending the body downward and forward by bending leg and spine. 
• Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound. 
• Kneeling: Bending legs at knee to come to a rest on knee or knees. 
• Lifting: Raising objects of 25lbs from a lower to a higher position or moving objects horizontally from position to position. This factor is important if it occurs to a considerable degree and requires the substantial use of the upper extremities and back muscles. 
• Pulling: Using upper extremities to exert force in order to draw, drag, haul or tug objects in a sustained motion. 
• Pushing: Using upper extremities to press against something with steady force in order to thrust forward, downward or outward. 
• Reaching: Extending hand(s) and arm(s) in any direction. 
• Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. 
• Sitting: Sitting for a period. 
• Standing: Remaining upright on the feet, particularly for sustained periods of time. ????? 
• Stooping: Bending body downward and forward by bending spine at the waist. 
• Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.? 
• Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another. 
• The worker is required to have close visual acuity to perform an activity such as: pre