Quality Control Specialist - HPLC

Description

Job Title: Quality Control Specialist - HPLC  

Location: Houston Headquarters’ Facility  

Department: Quality

Reports To: Quality Control and AD Manager

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 by a team of visionary scientists united by a common goal—to make life-changing gene therapies accessible to all. Witnessing the success of adeno-associated virus (AAV) vectors in restoring sight and hearing to patients, our team saw both the promise and the challenge: the high cost and complexity of vector production, which limited access to those who needed it most.

Determined to overcome these barriers, we built PackGene to revolutionize AAV manufacturing with innovative, scalable, and cost-effective solutions. Our work has enabled life-changing therapies, including a young boy born with congenital deafness. After receiving an AAV-based treatment produced by PackGene, he began responding to his family's voices. A few months later, he spoke his first word: “Dad.” His father wept with joy—a moment that reminded our team why we do what we do. It was more than just science; it was about restoring hope and giving families a future.

Today, PackGene is a global leader, serving clients in over 30 countries and partnering with more than 1,000 biopharmaceutical companies and research institutions. Our slogan, "Make Gene Therapy Affordable," reflects our unwavering mission. We focus on tackling key challenges in gene therapy development, including viral vector production and specific targeting, mRNA technologies, and GMP production at scale. We are committed to providing stable, qualified, cost-efficient, and fast services, along with technical support, to empower our gene therapy partners. Together, we aim to transform lives and build a healthier, better world.

Overview

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

General Responsibilities:

• 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 

Requirements

Qualifications

• Bachelor's degree in bioscience, chemistry or related field 
• 1~2 years’ experience working with HPLC 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: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.