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.
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; ORBachelor's degree in Life Science, Engineering, or related field with 5 years of related experience in large pharma / biotech operations or projectsProven ability to lead teamsExperience with electronic batch records, root cause analysis, technical writing, and initiation of investigationsPreferred Requirements
Experience working in facility start-up environmentExperience working in a pharmaceutical manufacturing environment1-3 years of leadership experienceLean Six Sigma or similar certificationWorking Conditions & Physical Requirements
Will work in environment which may necessitate respiratory protectionMay work in Mechanical / Production spaces that may require hearing protection and enrollment in a hearing conservation programWill work in environment operating a motor vehicle or Powered Industrial TruckAbility to discern audible cuesAbility to stand for prolonged periods of time - up to 240 minutesAbility to sit for prolonged periods of time - up to 240 minutesAbility to conduct activities using repetitive motions that include wrists, hands and / or fingersAbility to operate machinery and / or power toolsAbility to conduct work that includes moving objects up to 33 poundsAbility to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motionsWill work in warm / cold environmentsJob Locations US-NC-Holly Springs