Manufacturing Specialist
About The Position
PackGene Biotech is seeking a highly motivated and hands-on Manufacturing Specialist, specializing in AAV-based gene therapy, to join its fast-growing Houston site. This role is initially involved in Houston lab startup activities, planning and executing development studies, technology transfers, and new project implementation and execution in a timeline-driven manner. The company's mission is to accelerate gene therapy product development by providing integrated one-stop shop solutions to the gene therapy industry, aiming to make gene therapy accessible to more patients. PackGene Biotech was founded in 2014, is headquartered in Guangzhou, China, and is a leading gene therapy CRO/CDMO service provider in Asia, now planning to expand its operations to Houston, TX.
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
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
