QCAD Specialist in Houston, Texas at Packgene Biotech Inc

Job Title: QCAD Specialist

Location: Houston Headquarters’ Facility

Department: Quality

Reports To: Quality Control and Analytic Development 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

As our business grows quickly, we are looking for a qualified Quality Control Specialist to undertake laboratory works under the guidance of a manager or senior scientist. 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.

Job purpose

The Quality Control and Analytical Development (QCAD) Specialist will undertake laboratory work under the guidance of scientists and QCAD leadership in support of analytical development and GMP Quality Control activities for gene therapy products. The QCAD Specialist will execute a variety of molecular, biochemical, cellular, and other analytical laboratory techniques and will be cross-trained and qualified to perform a broad range of methods within the QCAD laboratory.

The QCAD Specialist will support analytical method development, optimization, qualification/validation, method transfer, and routine GMP testing, as appropriate to their training and qualification. The role requires continued development of technical proficiency across the QCAD assay portfolio and application of gene therapy concepts, cGMP requirements, good documentation practices, data integrity principles, and applicable laboratory procedures.

Duties and responsibilities

• Conduct laboratory testing and experiments according to approved procedures, protocols, methods, and study plans under the appropriate guidance of QCAD scientists and leadership.
• Operate a variety of laboratory equipment, which may include, but not limited to, qPCR and ddPCR instruments, plate readers, gel documentation imagers, pH meters, osmometers, cell counters, and other analytical instrumentation.
• Support instrument qualification, routine maintenance, troubleshooting, and other equipment lifecycle activities as assigned.
• Execute analytical methods that may include PCR/qPCR/ddPCR, ELISA, electrophoresis, spectrophotometric methods, cell-based assays, potency assays, and other molecular, biochemical, cellular, or microbiological methods, based on laboratory needs and individual training/qualification.
• Become trained and qualified to execute additional analytical methods and technologies across the QCAD testing portfolio.
• Perform routine GMP testing of raw materials, in-process samples, drug substance, drug product, stability samples, and other samples, as applicable.
• Support analytical method development and optimization activities by executing experiments, generating reliable data, documenting observations, and communicating results to technical leads.
• Perform method qualification/validation, verification, transfer, comparability, and implementation activities according to approved protocols and procedures.
• Perform calculations, review analytical data, assess system suitability and assay acceptance criteria, and identify unexpected or atypical results requiring further assessment.
• Draft and revise controlled laboratory documentation, including methods, SOPs, protocols, worksheets, technical documents, and study reports, as assigned.
• Routine lab activities may include:
• Prepare solutions, buffers, standards, controls, media, and reagents.
• Effectively plan lab activities by ensuring equipment readiness and reagent, consumable, standard, control and sample availability.
• Operate laboratory instruments in accordance with approved procedures and ensure required instrument checks, calibrations, maintenance, and documentation are completed as applicable.
• Identify instrument, assay, reagent, or method-related issues and perform initial troubleshooting within the individual's level of training and qualification, escalating issues when appropriate.
• Order lab reagents and supplies and monitor expiry of critical materials.
• Maintain an accurate sample inventory and ensure appropriate sample receipt, storage, handling, tracking, and disposition.
• Record all data and results following good documentation practices and applicable data integrity requirements.
• Document laboratory activities contemporaneously and accurately.
• Support laboratory investigations and troubleshooting activities by providing technical information, performing approved experimental work, and contributing to root cause assessments as appropriate.
• Collaborate closely with cross functional teams to ensure timely receipt and testing of samples and achievement of development, manufacturing, and product testing timelines.
• Package final product and samples for shipment.
• Arrange shipping of materials and proactively track of shipments.
• Provide peer training and technical support on methods and laboratory activities for which the Specialist II is appropriately trained and qualified.
• Maintain a clean and organized laboratory environment in accordance with applicable safety, GMP, and laboratory requirements.
• Maintain assigned training and analyst qualifications and proactively develop technical competency across multiple QCAD methods and analytical platforms.
• All other duties as assigned

Qualifications

• Bachelor’s Degree in Biological science or related field.
• 2+ years of relevant laboratory experience with a BS, or a relevant MS degree, with hands-on experience in a cellular or molecular biology, biochemical, or analytical laboratory environment.
• Hands-on experience with analytical technologies such as PCR/ddPCR/qPCR, ELISA and cell culture-based assays and qualification activities.
• Working knowledge of biologics, cell culture, AAV/viral vector manufacturing and experience with GxP/cGMP laboratory environment and knowledge of regulatory expectations is preferred.
• Experience supporting analytical method development, qualification/validation, transfer, troubleshooting, or routine GMP testing is preferred.
• 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 detail, accuracy and data integrity.
• Extensive experience working in a team-oriented, collaborative environment.
• Ability to manage multiple laboratory activities and priorities while meeting established testing and project timelines.
• Demonstrated commitment to continuous learning and development of technical proficiency across the QCAD analytical testing portfolio.

Working conditions

• In Office

Physical requirements

• Identify instrument, assay, reagent, or method-related issues and perform initial troubleshooting within the individual's level of training and qualification, escalating issues when appropriate.
• Order lab reagents and supplies and monitor expiry of critical materials.
• Maintain an accurate sample inventory and ensure appropriate sample receipt, storage, handling, tracking, and disposition.
• Record all data and results following good documentation practices and applicable data integrity requirements.
• Document laboratory activities contemporaneously and accurately.
• Support laboratory investigations and troubleshooting activities by providing technical information, performing approved experimental work, and contributing to root cause assessments as appropriate.
• Collaborate closely with cross functional teams to ensure timely receipt and testing of samples and achievement of development, manufacturing, and product testing timelines.
• Package final product and samples for shipment.
• Arrange shipping of materials and proactively track of shipments.
• Provide peer training and technical support on methods and laboratory activities for which the Specialist II is appropriately trained and qualified.
• Maintain a clean and organized laboratory environment in accordance with applicable safety, GMP, and laboratory requirements.
• Maintain assigned training and analyst qualifications and proactively develop technical competency across multiple QCAD methods and analytical platforms.
• All other duties as assigned