Process Science Technology Transfer Lead

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US

Process Science is a department that provides scientific leadership to support new product introduction as well as clinical, PPQ and commercial processes in large scale Drug Substance manufacturing, Drug Product as well as Finished Goods.

In the Technology Transfer team, we lead TTs and maintain an overview of TT progress, support CMC activities and look out for process compliance to filings. We continuously strive to identify opportunities to improve systems and practices.

The work environment is informal, where we strive to have a lot of fun, while we keep a high pace. The TT Lead is a critical role within FDBD as the business is in expansion and we introduce new programs and customers continuously.

The department continuously strives to identify opportunities to improve systems and practices and provides direction to the manufacturing organization. You will be involved in multi-disciplinary projects working in close collaboration with team members and/or in cross functional project groups.

RESPONSIBILITIES

• Lead Technology Transfer activities for clinical and commercial products into large scale manufacturing facility.
• Coordinate and lead regular meetings for TT programs with key stakeholders
• Develop PPQ strategies specific for each program in collaboration with internal stakeholders and customers
• Develop project plans that integrates with other scheduling functions within the organization and in alignment with program scope
• Escalation of risks and tracking of milestone progress.
• Ensure cross functional communication to key stakeholders.
• Support CMC activities for development and manufacturing and as required per the program including coordination and input to customer regulatory filings.
• Support the technical team to investigate any project challenges with necessary risk assessment tools and techniques.
• Execute on and support process trending and continued process verification plans. Review and document process performance and product health through process trending, monitoring, and supporting annual product reviews
• Point of Contact to customer and internal regulatory team for technical aspects of the process/program
• Identification of continuous improvements opportunities
• Support best practices for Tech Transfer and PPQ strategies globally as required

REQUIREMENTS

• Master's degree or a BS/BA in a scientific or engineering field.  You have 5+ years of experience, depending on educational background (Bachelor, Master or Ph.D.), within tech transfers in biopharmaceutical or related field with a broad background in drug substance development and. manufacturing
• Prior drug substance manufacturing experience, including  process validation, process transfer, commercialization, and manufacturing support and troubleshooting
• Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.
• Experience communicating and collaborating cross-functionally
• Excellent verbal and written communication, as well as presentation skills
• Flexible, organized and solution-oriented mindset.
• You are outgoing, have a positive can-do attitude, are proactive and with good organizational skills.
• Self-motivation and capability of working with a high degree of independency is something you master.
• Capability to absorb and utilize new knowledge quickly and drive data-based decisions.
• Able to travel, domestic and international (approximately 10-20%)