Manufacturing Specialist

About the Role

PackGene Biotech is looking for a highly motivated Manufacturing Specialist, specializing in AAV-based gene therapy, to join our Manufacturing team at our new Houston, TX site. Initially, the Manufacturing Specialist is involved in Houston lab startup activities, planning and executing development studies, technology transfers, new project implementation, and execution in a timeline-driven manner.

PackGene Biotech was founded in 2014 and is headquartered in Guangzhou, China. It is a leading gene therapy CRO/CDMO service provider in Asia and is planning to start up its operations in Houston, TX. 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 need.

Responsibilities

• Execution of initial manufacturing lab startup activities, including new equipment acquisition, coordinating with various vendors for equipment installation, and testing of new equipment.
• Perform manufacturing processes (solution prep, assembly prep, cell culture, purification, fill finish, and area cleaning) while following SOPs, batch records, and safety guidelines.
• Execute and document activities in compliance with regulatory requirements.
• Aseptically manipulate samples and submit samples to QC testing.
• Support inventory and supply coordination and tracking.
• Maintain manufacturing equipment by performing routine maintenance, calibrations, and troubleshooting of problems.
• Maintain cleanroom area organization.
• Author/Revise manufacturing documents including SOPs and Batch Records.
• Assist with training of new staff.
• Assist with organization of daily tasks.
• Support qualification of new equipment.
• Support new product introductions.
• Write deviations & support deviation investigations.
• Support change management and implementing corrective and preventive actions (CAPAs).
• Collaborate closely with other team members such as in QC, QA, PAD, MFG, Logistics, external and internal stakeholders.
• Perform other duties as assigned.
• Maintain high level of accountability, integrity, teamwork, and communication.
• Build strong & cohesive working relationships with colleagues across the company to accomplish goals.

Qualifications

• A.S. (B.S. or higher preferred) in biology, biotechnology, chemistry, engineering, or other gene therapy related field.
• With A.S.: 2~4+ years of related experience in biologics manufacturing (AAV viral vector experience is a plus).
• Advanced understanding of laboratory equipment and aseptic techniques.
• Prior experience working in a GMP environment is required.
• Experience in Cell culture, Purification, or Fill Finish is required.
• Proficient in MS Office suite of products.
• Demonstrated ability to work with a team.
• Excited to learn new things and open to new ideas.
• Passion for helping others.
• Excellent communication skills.
• Ability to work under pressure while maintaining professionalism.

Working Conditions

Manufacturing Lab Cleanroom

Physical Qualifications

• Reaching: Extending hand(s) and arm(s) in any direction.
• Standing: Remaining upright on the feet, particularly for sustained periods of time.
• Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.
• Sitting: Sitting for a period of time.
• Pushing: Using upper extremities to press against something with steady force in order to thrust forward, downward or outward.
• Pulling: Using upper extremities to exert force in order to draw, drag, haul or tug objects in a sustained motion.
• Lifting: Raising objects 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.
• 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.
• 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.
• Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
• 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.