Manufacturing Supervisor, Drug Substance Manufacturing

FUJIFILM Biotechnologies; Holly Springs (NC); In loco; USD 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Relocation assistance

Descrizione del lavoro

FUJIFILM Biotechnologies in Holly Springs, NC seeks an Upstream/Downstream Supervisor to lead a shift of 7–10 manufacturing associates, drive readiness for GMP production, and coordinate cross-functional activities. You will develop training plans, ensure safety, quality, and regulatory compliance, and support investigations and continuous improvement.

Relocation assistance is available; ideal candidates have 8+ years in biotech/pharma operations and a life sciences background with supervisory

Competenze

• High school diploma or GED required.
• 8+ years in a similar role within large-scale pharmaceutical/biotech operations or projects.
• Experience leading, supervising, or managing employees.
• Experience in a regulated manufacturing environment.

Mansioni

• Provide on-the-floor leadership for a shift of 7–10 manufacturing associates.
• Coordinate manufacturing schedule with daily shift assignments and escalations.
• Lead commissioning, qualification, and startup readiness activities.
• Develop and execute team training plans for initial GMP production.
• Support investigations, root-cause analysis, CAPA, and continuous improvement initiatives.
• Maintain compliant cGMP operations and document control.

Conoscenze

Team leadership

Cross-functional coordination

Training planning

GMP/GxP knowledge

Investigations and CAPA

Formazione

High school diploma or GED

Bachelor's degree in life sciences

Associate degree in life sciences

Descrizione del lavoro

Position Overview

As an Upstream or Downstream Supervisor, you will lead and develop a team of manufacturing associates supporting the startup and ongoing operation of a large-scale biopharmaceutical facility. You will build team capability, execute training plans, support commissioning, qualification, and operational-readiness activities, and ensure work is performed safely, consistently, and in compliance with cGMP requirements. You will also coordinate cross-functional activities, manage shift priorities and escalations, maintain controlled documentation, support investigations and corrective actions, and drive continuous improvement. During operations, you and your team will work a 2-2-3, 12-hour shift schedule to support reliable manufacturing performance. This is an opportunity to help launch a new facility and establish a strong culture of safety, quality, and operational excellence.

Relocation assistance is available.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll Do

Project Phase

• Support commissioning and qualification activities in preparation for manufacturing operations.
• Lead and support operational-readiness activities, including document review and approval, team onboarding, materials management, and cross-functional coordination.
• Develop and execute a training plan to prepare the team for initial GMP production.
• Lead, mentor, and develop team members through onboarding, training, regular communication, and performance support.
• Administer company policies that directly impact employees, including travel and expense, time reporting, time off, and other applicable workplace policies.
• Coordinate with cross-functional support groups to ensure readiness for startup activities.

Operations

• Provide on-the-floor leadership for a shift team of approximately 7-10 manufacturing associates.
• Coordinate execution of the manufacturing schedule through daily shift assignments, shift huddles, and timely escalation management.
• Foster an inclusive, people-first culture through regular communication, team engagement, and recurring one-on-one meetings focused on employee development and success.
• Promote a strong safety and quality culture by conducting Gemba walks, reinforcing safe work practices, and ensuring direct reports maintain current, role-appropriate training.
• Maintain a compliant cGMP manufacturing environment and ensure work is performed in accordance with applicable procedures, policies, and regulatory requirements.
• Support manufacturing investigations, root-cause analysis, corrective and preventive actions, and continuous improvement initiatives.
• Coordinate with maintenance, calibration, and other functional groups requiring access to manufacturing areas, equipment, or systems.
• Administer employee policies affecting manufacturing operations, including time reporting, time off, shift policies, and inclement weather procedures.

Basic Requirements

• High school diploma or GED.
• 8 or more years of experience in a similar role within large-scale pharmaceutical, biotechnology, or related manufacturing operations or project environments.
• Experience leading, supervising, or managing employees.
• Experience working in a regulated manufacturing environment.

Preferred Requirements

• Bachelor's degree in life sciences with 4 or more years of experience in a similar role within large-scale pharmaceutical or biotechnology operations or projects; OR
• Associate degree in life sciences with 6 or more years of relevant experience; OR
• Equivalent military experience.
• Experience manufacturing biological products.
• Familiarity with GMP and GLP requirements.
• Experience supporting commissioning, qualification, startup, operational readiness, or manufacturing operations.
• Demonstrated ability to lead teams, coordinate cross-functional activities, and manage competing priorities in a fast-paced environment.

PHYSICAL REQUIREMENTS AND WORKING ENVIRONMENT

• May work in environments requiring respiratory protection.
• May work in mechanical or production areas requiring hearing protection and enrollment in a hearing conservation program.
• Ability to discern audible cues.
• Ability to ascend and descend ladders, scaffolding, ramps, and similar structures.
• Ability to work at heights greater than four feet.
• Ability to stand and sit for prolonged periods.
• Ability to perform repetitive motions involving the wrists, hands, and fingers.
• Ability to move objects weighing up to 10 pounds.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).