What are the responsibilities and job description for the Supervisor, Drug Product Filling position at FUJIFILM Biotechnologies?
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.
The schedule for this role will be 3pm to 11:30pm (2nd shift), Monday through Friday.
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 and Physical Requirements
- Will work in environment which may necessitate respiratory protection
- May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
- Will work in environment operating a motor vehicle or Powered Industrial Truck
- Ability to discern audible cues
- Ability to stand for prolonged periods of time - up to 240 Minutes
- Ability to sit for prolonged periods of time - up to 240 Minutes
- Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
- Ability to operate machinery and/or power tools
- Ability to conduct work that includes moving objects up to 33 pounds
- Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions
- Will work in warm/cold environments
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.