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 skilled Director of Process Engineering.
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).
The position requires expertise in at-scale manufacturing processes (upstream and downstream) and technology transfer for microbial and/or related systems. With a demonstrable expertise in regulatory compliance, process dynamics of new facility construction, those interested will:
- Lead technical discussion with internal and external stakeholders across all aspects of design and development of manufacturing area and process
- Develop and build process understanding and expertise for microbial based fermentation and relevant downstream processes
- Build and develop process and production control strategies in support of facility readiness, regulatory approval, and future routine operations
- Be the technical authority, and as such interface with clients on developing manufacturing projects
- Play a lead role in the evaluation for design of production equipment, performing technical review, vendor selection, oversee installation and qualification (FAT, SAT)
- Active contribution to strategy development and ongoing evolution for process qualification and execution
- Project manage, with development group technology transfer and scale up of customer products
- Lead the department in the implementation and improvement of practices and procedures related to GEP, GMP, product and process quality, cost, and schedule adherence
With a relevant technical education and complimentary experience developed in the biological manufacturing industry, ideally in process of microbial fermentation, recovery, and purification in biological, you will be a skilled technical leader manager who brings exceptional leadership skills, and collaborative style.
As a technical authority, you be able to demonstrate a history in process development, technology transfer or large-scale manufacturing process including fermentation, centrifugation, filtration, and lyophilization for biological drug substances. As well as US FDA governance for biological drug substance manufacture.
You will be afforded significant autonomy, and as such must be able to work independently and be self-motivated.
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 firstname.lastname@example.org