Our client is at the forefront of their field. Working with live biotherapeutics they are harnessing bacterial science to create a healthier world.
With a 17-acre site secured, our client is building a 120k square feet, greenfield site that will contain state of the art technology, and once fully operational be home to more than 200 people. The site will create the platform to position themselves as the premier CDMO in the field.
In support of this incredible project, we are looking to secure the services of a talented Project Director.
This is a critical role in the wider project team tasked with the construction of a greenfield bulk biological drug substance manufacturing plant, intended for phase 3 and commercial level manufacture of live biotherapeutic products (LBP).
As Project Director you will possess extensive pharma and/or bio manufacturing process, regulatory compliance, and related manufacturing quality-based expertise. Those interested will:
- Proactively contribute to the project plan and take responsibility for the delivery of areas of specific responsibility
- Partner with engineering partners to support facility design work through concept design, basis of design and detail design to ensure compliance with regulatory requirements for manufacture of bulk biological drug substance
- Support and develop quality risk assessment for design of the facility and ensure appropriate mitigation plans are in place
- Review and implement key quality and documentation system for early project phase
- Support development of Commissioning and Qualification, site approval inspection strategy and jointly lead execution program
- Support process equipment procurement from identification of vendor, technical evaluation, order progress, design qualification activities including FAT and SAT
- Proactively analyze project risk and take prevent measures for prevention or resolution
- Lead and/or support FDA regulatory process for facility design review (Type C meeting) and acceptance in collaboration with a contract regulatory liaison
- Work with engineering partners on schedule adherence and change management
- Bring overall coordination for commissioning, qualification, validation of utilities, equipment, and manufacturing process
- Ensure close collaboration across project activities with a wide range of stakeholders and partners
With a relevant technical education and complimentary experience developed in the pharmaceutical, biotechnology, and/or or GMP manufacturing industry, with extensive technical expertise in Quality Assurance and manufacturing operations for biological drug substances.
You will be a skilled technical leader, with a high degree of competence in US FDA requirements governing manufacturing operations. Furthermore, individuals will bring wide knowledge of manufacturing and design control principles and practices for the biopharma industry.
You will be afforded significant autonomy, and as such must be able to work independently. That said our client’s culture is one of successful collaboration, so you will thrive in a team environment, working with colleagues to delivery impressive performance.
Working in an entrepreneurial culture, you will be able to navigate ambiguity, demonstrate agility and embrace innovation to deliver success. It goes without saying that you will be a skilled communicator, with the ability to negotiate and influence people at all levels.
This is a rare and exciting opportunity to shape a greenfield facility and in doing so build an operation that will improve health while creating opportunities for hundreds of people across the local community.
If you would like to know more or apply, then please contact us with a recent resume at email@example.com