Project Manager

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 and headquartered in Guangzhou, China. It provides CRO/CDMO services to the emerging gene therapy industry and research institutes. PackGene Biotech (US) is a full subsidiary of the parent company and is expanding its global footprint to Houston TX.  

PackGene is looking for highly motivated individuals to join our growing Houston site and lead GMP operations.

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.

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. 

• 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.
• 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 ma