Manufacturing Supervisor/ Manager

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 need.

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 and 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.

PackGene is looking for a highly motivated hands-on individual to join our fast-growing Houston site. A fantastic opportunity to join a dynamic team and make a great impact!

Manufacturing Supervisor/Manager

We are currently looking for a highly motivated Manufacturing Manager, specializing in AAV-based gene therapy to join our Manufacturing team.

Initially, the Manufacturing Supervisor/Manager will be involved in the Houston facility’s startup activities including: Equipment identification, Commissioning/Validation activities, SOP generation, Technology Transfer, Production area organization, Hiring of new staff, and Manufacturing system/culture creation.

Once the Houston facility has been established, the Manufacturing Supervisor/ Manager will be responsible for leading a team(s) of specialists focused on gene therapy product manufacture, performing all associated activities including solution preparation, cell culture, purification, and fill finish.

The Manufacturing Supervisor/Manager will have responsibility to ensure multiple functions within manufacturing (Solution Prep, Upstream, Downstream, or Fill Finish) operate successfully. At all times the Manufacturing Supervisor/Manager will be expected to look for ways to improve the manufacturing system and drive the culture of the team in a positive direction.

Responsibilities

• Supervise manufacturing team to ensure daily tasks are completed successfully and the production schedule is maintained.
• Set and maintain production schedule and training curriculum for area.
• Hire, coach, and develop staff while ensuring culture of safety and quality.
• 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 and improve cleanroom area organization and audit/inspection readiness.
• Review executed forms, logbooks, and batch records for completeness and to ensure that they follow GDPs.
• Author/Revise/Approve manufacturing documents including SOPs and Batch Records.
• Support and drive improvements in area and process.
• Support qualification of new equipment.
• Support new product introductions.
• Write deviations & perform deviation investigations.
• Own and drive to completion change controls and CAPAs.
• Collaborate closely with other team members such in QC, QA, Process Development, Production, Material Management, external and internal stakeholders.
• Help with maintaining budget and headcount requirements.
• 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 company goals.

Qualifications

• B.S. in biology, biotechnology, chemistry, engineering, or other gene therapy related field.
• Manager: 10~12+ years of related experience in biologics manufacturing (AAV viral vector experience is a plus).
• Supervisor: 6~8+ years of related experience in biologics manufacturing (AAV viral vector experience is a plus).
• Senior Supervisor: 8~10+ years of related experience in biologics manufacturing (AAV viral vector experience is a plus).
• Demonstrated ability to lead a team, hire staff, and maintain quality standards.
• Proven skill in managing cross-functional projects.
• 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.
• Experience with GMP facility startup is a plus.
• Experience interacting with external clients.
• Proficient in MS Office suite of products and technical writing ability.
• Advanced understanding of Lean Six Sigma and 6S.
• 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:

• The worker is subject to hazards: Bio Safety Level 2.

Physical Qualifications:

• 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, pulling and pushing up to 50 lbs
• 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.