Associate Manager, DSM (Downstream)

Overview

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 cell culture 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

About This Role

 

The Associate Manager of DSM leads a team of manufacturing associates (MA’s) for manufacturing bulk drug substance. The Associate Manager is responsible for the departments training and regulatory compliance, ensuring schedule adherence, and their associated activities to ensure compliant and reliable start up activities and production.

 

What You’ll Do

 

Project Phase (Through Mid-2025)

 

•Supports Factory Acceptance Testing (FAT) at the vendor site, as required•Supports Site acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation, as applicable•Performs other operational readiness tasks as required, such as: document review/approval, team onboarding, and materials management•Supervises manufacturing associates on technical and operational topics, such as: area unit operations and equipment•Enforces company policies (e.g., travel & expense, time reporting, and time off that directly impact employees)•Leads peer department management in tactical and strategic development•Coaches’ direct reports to foster individual and team professional development and growth•Supports and leads water and engineering batch schedule attainment•Collaborates with partners, vendors, and key stakeholders, as needed•Other duties, as assigned

 

Operations Phase (Starting Mid-2025)

 

•Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associates•Coordinates the execution of the manufacturing schedule through daily shift assignments, lead daily huddles, and manages escalations•Fosters an inclusive, people-first culture with regular communication, conducting 1:1s on a defined cadence with direct reports•Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training•Supports manufacturing investigations and continuous improvement projects•Coordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment, such as but not limited to: maintenance, calibration activities and the use of manufacturing equipment•Administers company policies, such as but not limited to: time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employees•Coaches and guides direct reports to foster individual and team professional development and growth•Participates in the recruitment process and retention strategies to attract and retain talent•Addresses performance gaps, employee concerns, and partners with HR as needed for resolution•Leads peer department management in tactical and strategic development•Supports and leads water and engineering batch schedule attainment as required for the tech transfer of new products•Collaborates with partners, vendors, and key stakeholders, as needed while executing the day-to-day manufacturing activities•Other duties, as assigned

 

Who You Are

 

You have the ability to collaborate with cross-functional areas and global teams. You demonstrate strong organizational skills and project management capabilities. You actively champion continuous imprvement practices and ideas. You have the ability to coach, lead and develop individual contributor and department peers.