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Position Overview

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.

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

+ 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

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

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 hearting conservation program

+ Ability to discern audible cues

WORKING ENVIRONMENT

_PHYSICAL DEMANDS_

+ 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.

_ENVIRONMENTAL CONDITIONS_

+ Will work in heights greater than 4 feet

_To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._

**Job Locations** _US-NC-Holly Springs_

**Posted Date** _1 month ago_ _(9/4/2025 12:04 PM)_

**_Requisition ID_** _2025-35521_

**_Category_** _Manufacturing_

**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_