Supervisor, Drug Product Filling
The Supervisor, Drug Product Filling supports start up and operational activities for the site. This role leads a shift team and is responsible for the manufacturing process and facility which will eventually operate 24 / 7 model.
Job Description
What You'll Do
Provides on the floor leadership for a shift team of Manufacturing Associates
Oversees and coordinates the execution of the manufacturing schedule through daily shift assignments and huddles
Serves as the point of contact for escalations and provides guidance to resolve issues
Fosters an inclusive, People-First Culture with regular communication, conducting 1 : 1s on a defined cadence with direct reports
Maintains a safe and current good manufacturing practice (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
Enforces company policies that directly impact employees (e.g., time reporting, time off approvals, shift work, and inclement weather)
Supports Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Operational Qualification (OQ), and Performance Qualification (PQ), travel as needed
Manages and develops direct reports from Filling team
Administers company policies such as time off, shift work, and inclement weather that directly impact employees
Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
Coaches and guides direct reports to foster professional development
Participates in the recruitment process and retention strategies to attract and retain talent, as needed
Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
Performs other duties, as assigned
Basic Requirements
High School diploma / GED with 9 years of related experience in large pharma / biotech operations or projects; OR Bachelor's degree in Life Science, Engineering, or related field with 5 years of related experience in large pharma / biotech operations or projects
Proven ability to lead teams
Experience with electronic batch records, root cause analysis, technical writing, and initiation of investigations
Preferred Requirements
Experience working in facility start-up environment
Experience working in a pharmaceutical manufacturing environment
1-3 years of leadership experience
Lean Six Sigma or similar certification
Working Conditions & Physical Requirements
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.
Drug Product • Holly Springs, NC, US