Position Title: Manufacturing Specialist II, III, or Lead

Site: Houston HQ Facility

Department: Manufacturing

Reports to: Manager, Manufacturing

FLSA Status: Non-Exempt

Job Status: Full-Time

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!

Requirements

Manufacturing Specialist II, III, or Lead

We are currently looking for a highly motivated Manufacturing Specialist II, III, or Lead , specializing in AAV-based gene therapy to join our Manufacturing team.

Initially, the Manufacturing Specialist II, III, or Lead will be involved in the Houston facility’s startup activities including: Equipment identification, Commissioning/Validation activities, SOP generation, Technology Transfer, Production area organization, and Manufacturing system/culture creation.

Once the Houston facility has been established, the Manufacturing Specialist will be responsible for gene therapy product manufacture, performing all associated activities including: solution preparation, cell culture, purification, and fill finish. At all times the Manufacturing Specialist will be expected to look for ways to improve the manufacturing system and contribute positively to the culture of the team.

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.
• Review executed forms, logbooks, and batch records for completeness and to ensure that they follow GDPs.
• Author/Revise manufacturing documents including SOPs and Batch Records.
• Assist with training of new staff.
• Lead 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 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.
• Other duties as assigned

Qualifications

• A.S. (B.S. or higher preferred) in biology, biotechnology, chemistry, engineering, or other gene therapy related field.
• With A.S.: 4~6 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:

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

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: Raising objects of 30 lbs 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.