Downstream Supervisor (Biologics) - Day Shift

About the 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 flexibility with working hours.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the 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.

Responsibilities

The role has two phases: Project Phase (through mid-2025) and Operations Phase (starting mid-2025).

During the Project Phase, responsibilities include:

• Supporting Factory Acceptance Testing (FAT) at the vendor site as required
• Supporting Site acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation, as applicable
• Performing other operational readiness tasks as required, such as document review/approval, team onboarding, and materials management
• Supervising manufacturing associates on technical and operational topics, such as area unit operations and equipment
• Administering company policies, such as travel & expense, time reporting, and time off that directly impact employees

During the Operations Phase, responsibilities include:

• Providing on-the-floor leadership for a shift team of up to 7-10 manufacturing associates
• Coordinating the execution of the manufacturing schedule through daily shift assignments, leading daily huddles, and managing escalations
• Fostering an inclusive, people-first culture with regular communication, conducting 1:1s on a defined cadence with direct reports
• Maintaining a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training
• Supporting manufacturing investigations and continuous improvement projects
• Coordinating with other functional areas for additional activities requiring access to the manufacturing space and equipment
• Administering company policies, such as time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employees

Requirements

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

Physical Requirements

Physical Demands:

• Will work in an environment which may necessitate respiratory protection
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
• Ability to discern audible cues

Working Environment:

• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time
• Ability to sit for prolonged periods of time
• Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 lbs.
• Will work in heights greater than 4 feet