Scientist I/II, CRO - Downstream at PACKGENE BIOTECH INC

Houston, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Apr, 26

Salary

0.0

Posted On

14 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Downstream Process Development, Viral Vectors, Chromatography Purification, GMP Operations, Technical Documentation, Data Analysis, Problem Solving, Team Collaboration, Training, Client Interaction, Quality by Design, Design of Experiments, Biologics Development, Technical Support, Multitasking, Communication

Industry

Biotechnology Research

Description

Description Job Title: Scientist I/II, CRO – Downstream Location: Houston Headquarters Facility Department: Process Development and CRO Reports To: Associate Director 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 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. 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. Requirements Duties and 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. Skills and Qualifications 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. Other duties as assigned. Working conditions Onsite location with occasionally sitting at a desk as well as frequently walking and standing in the lab to perform lab work. 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 of time. 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. Direct reports NONE

Responsibilities

The Scientist I/II will participate in planning and executing lab operations, focusing on downstream unit operations and process development. They will also serve as a subject matter expert and work with cross-functional teams to ensure successful technology transfer into GMP.