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Description

Position Title: Project Manager

Site: Houston, TX

Department: Project Management

FLSA Status: Exempt

Job Status: Full-Time

Reports to: Chief Technical Officer

Mission Statement

The mission of PackGene Biotech is to accelerate gene therapy product development by providing an integrated one-stop solution including plasmid, viral vector, fill-finish and QC analytical services for the gene therapy industry.

Company Background

PackGene Biotech was founded in 2014 by a team of visionary scientists united by a common goal-to make life-changing gene therapies accessible to all. Witnessing the success of adeno-associated virus (AAV) vectors in restoring sight and hearing to patients, our team saw both the promise and the challenge: the high cost and complexity of vector production, which limited access to those who needed it most.

Determined to overcome these barriers, we built PackGene to revolutionize AAV manufacturing with innovative, scalable, and cost-effective solutions. Our work has enabled life-changing therapies, including a young boy born with congenital deafness. After receiving an AAV-based treatment produced by PackGene, he began responding to his family's voices. A few months later, he spoke his first word: "Dad." His father wept with joy-a moment that reminded our team why we do what we do. It was more than just science; it was about restoring hope and giving families a future.

Today, PackGene is a global leader, serving clients in over 30 countries and partnering with more than 1,000 biopharmaceutical companies and research institutions. Our slogan, "Make Gene Therapy Affordable," reflects our unwavering mission. We focus on tackling key challenges in gene therapy development, including viral vector production and specific targeting, mRNA technologies, and GMP production at scale. We are committed to providing stable, qualified, cost-efficient, and fast services, along with technical support, to empower our gene therapy partners. Together, we aim to transform lives and build a healthier, better world.

Requirements

Overview

As a Project Manager, you will play a pivotal role in driving the successful planning, execution, and completion of cross-functional projects within the PackGene Houston manufacturing facility. You will collaborate with a diverse team of scientists, engineers, manufacturing, quality, and business professionals to ensure the seamless delivery of projects that contribute to our mission of making gene therapy affordable.

Role Description

Project Planning and Strategy: Develop comprehensive project plans, outlining scope, goals, timelines, and resource requirements. Align project objectives with the company's strategic goals and ensure clear communication of project expectations to all stakeholders.

Team Leadership: Lead and motivate interdisciplinary project teams, including scientists, engineers, specialists, lab associates and other relevant stakeholders. Foster a collaborative and results-driven environment that encourages innovative thinking and effective problem-solving.

Customer relationship: build a long-term relationship with customers. Proactively understand customer needs and deliver to customers' expectations.

Risk Management: Identify potential risks and develop mitigation strategies to ensure project milestones are achieved on time and within budget. Proactively address any roadblocks or challenges that may arise during project execution.

Resource Allocation: Work closely with department heads to allocate resources effectively, ensuring that personnel, equipment, and budgets are appropriately allocated to achieve project goals.

Progress Tracking and Reporting: Establish mechanisms for tracking project progress, collecting relevant data, and generating regular status reports. Provide transparent updates to senior management and stakeholders, highlighting accomplishments, challenges, and proposed solutions.

Communication: Facilitate clear communication among project team members, as well as with external clients, ensuring that information flows seamlessly between different departments and individuals. Act as the main point of contact for customer project-related inquiries.

Other duties as assigned.

Qualifications

• Bachelor's degree in a relevant scientific, technical, or business discipline. Advanced degree (MSc, MBA, PhD) preferred.
• Proven experience (3+ years) in project management within the biotechnology, pharmaceutical, or life sciences industries.
• Demonstrated success in leading cross-functional teams and managing complex projects from inception to completion.
• Strong understanding of biotech CDMO industry trends, regulations, and challenges.
• Strong GMP and regulatory knowledge, understand FDA and EMA regulations and ICH guidance's.
• Excellent leadership, interpersonal, and communication skills.
• Proficiency in project management software and tools.
• PMP or other relevant project management certification is a plus.

Work Location:

Onsite

Physical Qualifications of the Job

The ability to communicate effectively verbally and in written format with customers, management, and other co-workers, both individually and in front of a group is crucial. 

• 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 up to 50 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.? 
• The worker is subject to hazards: Bio Safety Level 2.?