Manufacturing Specialist

PackGene Careers•Houston, TX

3d•Onsite

About The Position

PackGene Biotech is seeking a highly motivated and hands-on Manufacturing Specialist, specializing in AAV-based gene therapy, to join its growing Manufacturing team in Houston, TX. This role will initially involve lab startup activities, planning and executing development studies, technology transfers, and new project implementation in a timeline-driven manner. The company's mission is to accelerate gene therapy product development by providing integrated solutions to the gene therapy industry, aiming to make gene therapy more accessible to patients.

Requirements

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.

Nice To Haves

B.S. or higher in biology, biotechnology, chemistry, engineering, or other gene therapy related field.
AAV viral vector experience is a plus.

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.