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 DescriptionWhat You’ll Do
Project Phase (Through Mid-2025)
Supports Factory Acceptance Testing (FAT) at the vendor site as requiredSupports Site acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation, as applicablePerforms other operational readiness tasks as required, such as: document review/approval, team onboarding, and materials managementSupervises manufacturing associates on technical and operational topics, such as: area unit operations and equipmentAdministers company policies, such as, but not limited to: travel & expense, time reporting, and time off that directly impact employeesOperations Phase (Starting Mid-2025)
Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associatesCoordinates the execution of the manufacturing schedule through daily shift assignments, lead daily huddles, and manages escalationsFosters an inclusive, people-first culture with regular communication, conducting 1:1s on a defined cadence with direct reportsMaintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date trainingSupports manufacturing investigations and continuous improvement projectsCoordinates 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 equipmentAdministers company policies, such as but not limited to: time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employeesPerforms 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 projectsPreferred Requirements
BA/BS Degree in Life Sciences with 4+ years of experience from a similar role in large pharma/biotech operations or projects ORAssociates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma/biotech operations or projects ORMilitary Experience of equivalenceExperience in manufacturing of biological products, familiar with GMP/GLP requirementsPrevious experience leading, supervising or managing others
PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
Will work in an environment which may necessitate respiratory protectionMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearting conservation programAbility to discern audible cuesWORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc.Ability to stand for prolonged periods of timeAbility 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 feetTo 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.
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