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

The mission of Pack Gene 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.

Pack Gene 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 Pack Gene 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 Pack Gene, 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, Pack Gene 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  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.

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.

• 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

• 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

• In laboratory

• Crouchi…