Associate Manager, DSM

Position Overview

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.

Company Overview

FUJIFILM Diosynth Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

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

 

Basic Requirements

 

• High School Diploma/GED with 8 years of related experience; OR• Bachelor’s degree in Life Science, Engineering, or related field with 4 years of related experience; OR• Master’s degree in Life Science, Engineering, or related field with 2 years of related experience• 2 years of experience managing a team • Experience with regulatory inspections, investigations, and change management

 

Preferred Requirements

 

• Experience leading a team in a pharmaceutical or biological manufacturing operations• Experience working in a changing and project driven organization• Previous experience di