Holly Springs, NC, 27540, USA
1 day ago
Downstream Supervisor (Biologics) - Day Shift
**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** _2 days ago_ _(9/4/2025 12:04 PM)_ **_Requisition ID_** _2025-35521_ **_Category_** _Manufacturing_ **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_
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