Scientist I/II, PD Downstream

PACKGENE BIOTECH INC•Houston, TX

31d•Onsite

About The Position

The mission of PackGene Biotech is to accelerate gene therapy product development by providing an integrated one-stop shop solution to the gene therapy industry. We strive to make gene therapy accessible to more patients in needs. Gene therapy is believed to revolutionize the healthcare field in upcoming years. PackGene is well positioned to play a big role in this transformation. 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.

Requirements

Ph.D. or M.S. in Biology, Biotechnology, Engineering, or other gene therapy-related field.
1-4+ years for Ph.D. or 4-8 years for M.S. of industrial experience in Biologics development, including protein, antibody, and viral vectors (AAV, or lentiviral vector).
Proficient in QbD based approach utilizing Design of Experiments (DOE).
Working knowledge of GMP, FDA-regulated industry.
Demonstrated ability to work cross functionally in multi-disciplinary teamwork.
Proficient in MS Office suites of products.
Ability to multitask, prioritize work independently.
Capable of analyzing problems and finding solutions.
Ability to work under pressure while maintaining a professional manner.

Nice To Haves

Downstream process development and operation experience of viral vectors or protein/antibody therapeutics is strongly preferred.

Responsibilities

Participate in planning and hands-on execution of lab operation activities, including new equipment acquisition, training and maintenance.
Hands-on execution of downstream unit operations such as clarification and filtration, tangential flow filtration (TFF), chromatography purification with AKTA system and ultracentrifugation unit operations.
Downstream process development and operation experience of viral vectors or protein/antibody therapeutics is strongly preferred.
Maintain a high level of technical acumen in the field of viral vector downstream process.
Participate in client meetings and serve as a downstream process subject matter expert (SME).
Work with a cross-functional team to perform technology transfer of downstream procedures into GMP.
Ability to pass gowning training and support GMP operations in cleanrooms
Design and execute downstream development studies, involving suspension and adherence platform process. Occasional weekend work may be required.
Perform timely data acquisition, analysis and troubleshooting; report project progress in cross-functional team meetings.
Ability to troubleshoot process and equipment, and support deviation investigations and make scientifically sound decisions
Draft and review technical documents such as protocols, technical reports, and risk assessments.
Ability to perform scientific review of master batch records and SOPs.
Ability to create and review Unicorn methods for accuracy.
Ensure timeline adherence
Coach of junior associates on experimental rationale, design, execution and troubleshooting.
High level of accountability, integrity and communication; foster a culture of collaboration, trust, and teamwork.
Build strong and cohesive working relationships with colleagues from other teams to accomplish company goals.