Position OverviewThis 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 DoProject 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 REQUIREMENTSPHYSICAL 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 ENVIRONMENTPHYSICAL 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.
