Supervisor, DSM (Downstream)

at  Fujifilm

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.

BASIC REQUIREMENTS

• High School Diploma or GED with 8 years of experience from a similar role in large pharma/biotech operations or projects

PREFERRED REQUIREMENTS

• BA/BS Degree in Life Sciences with 4+ years of experience from a similar role in large pharma/biotech operations or projects OR
• Associates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma/biotech operations or projects OR
• Military Experience of equivalence
• Experience in manufacturing of biological products, familiar with GMP/GLP requirements
• Previous experience leading, supervising or managing others

ABOUT THIS ROLE

This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

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
• Administers company policies, such as, but not limited to: travel & expense, time reporting, and time off that directly impact employees

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
• Performs other job as assigned