Manufacturing Supervisor, Upstream

Fujifilm•Holly Springs, NC

2d•Onsite

About The Position

The Manufacturing Supervisor, Upstream, will lead and develop a team of manufacturing associates supporting the start-up and operation of a large-scale cell culture facility in Holly Springs, North Carolina. The upstream area includes an inoculum lab, two seed reactor trains, four 20,000-liter production reactors, a harvest suite, media preparation, and a parts preparation area. The team follows a 2-2-3 schedule with 12-hour shifts. During the project phase, the supervisor supports commissioning and qualification, operational readiness, team onboarding, document review and approval, materials management, and development and execution of team training in preparation for the first GMP batches. In the operations phase, the supervisor provides on-floor leadership for a shift team of up to 7–10 manufacturing associates, coordinates the manufacturing schedule and shift assignments, leads daily huddles, handles escalations, and supports a safe, inclusive, and cGMP-compliant work environment. The role also supports investigations and continuous improvement and coordinates manufacturing-area access and activities with other functions.

Requirements

High school diploma or GED and 8 years of experience in a similar role in large pharmaceutical or biotechnology operations or projects.
Ability to work a 2-2-3 schedule with 12-hour shifts.
Ability to work in an environment that may require respiratory protection.
Ability to discern audible cues.
Ability to ascend or descend ladders, scaffolding, ramps, and similar structures.
Ability to stand and sit for prolonged periods.
Ability to perform repetitive motions involving the wrists, hands, or fingers.
Ability to move objects weighing up to 10 pounds.
Ability to work at heights greater than 4 feet.

Nice To Haves

Bachelor’s degree in life sciences and 4 or more years of experience in a similar role in large pharmaceutical or biotechnology operations or projects.
Associate degree in life sciences and 6 or more years of experience in a similar role in large pharmaceutical or biotechnology operations or projects.
Equivalent military experience.
Experience manufacturing biological products and familiarity with GMP/GLP requirements.
Previous experience leading, supervising, or managing others.

Responsibilities

Support commissioning and qualification activities during the project phase.
Lead and support operational readiness tasks, including document review and approval, team onboarding, and materials management.
Build and execute a training plan to prepare the team for the first GMP batches.
Mentor and develop team members.
Administer company policies affecting employees, including travel and expense, time reporting, and time off.
Collaborate and coordinate with cross-functional support groups on start-up activities.
Provide on-the-floor leadership for a shift team of up to 7–10 manufacturing associates.
Coordinate manufacturing schedule execution through daily shift assignments, lead daily huddles, and manage escalations.
Foster an inclusive, people-first culture through regular communication and one-on-one meetings focused on team members’ development and success.
Maintain a safe and cGMP-compliant environment by ensuring direct reports’ training is current, performing gemba walks, and promoting a safety- and quality-minded culture.
Support manufacturing investigations and continuous improvement projects.
Coordinate activities requiring access to manufacturing spaces and equipment with other functional areas, including maintenance and calibration.
Administer policies affecting manufacturing employees, including time reporting, time off, shift policies, and inclement weather policies.