Bioprocess Downstream Lead — 12-Hour Shift

FUJIFILM Biotechnologies; North Carolina; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) plan with company contributions

Paid vacation and holidays

Job summary

FUJIFILM Biotechnologies is seeking an Associate Manager of Manufacturing Downstream to lead a cross‑functional team on a 12‑hour day shift (7am–7pm). You will oversee chromatography and UFDF operations, coordinate with Process Science, OBX, MT&S, and ensure GMP compliance and inspection readiness across multiple clinical and commercial programs.

The role requires hands‑on bioprocessing experience, strong leadership, and the ability to mentor staff while driving continuous improvement in a

Qualifications

• Must have strong leadership and coaching skills for a 12‑hour shift
• Experience implementing GMP/EHS and leading investigations and CAPA
• Proven ability to manage cross‑functional teams in a regulated environment
• Hands-on bioprocessing knowledge with focus on downstream operations

Responsibilities

• Lead daily and weekly operations on a 12‑hour shift
• Direct downstream chromatography and recovery operations
• Coordinate production campaigns for multiple client programs
• Ensure equipment, materials, and schedule readiness to meet production plans
• Act as shift contact for cross‑functional teams and maintain inspection readiness
• Mentor direct reports and manage performance, development, and HR issues
• Support audits, investigations, and continuous improvement projects

Skills

Leadership

GMP/EHS compliance

Cross-functional collaboration

Problem-solving

Communication

Mentoring

Shift management

Change management

Troubleshooting

Project management

Education

Master's degree in engineering or Life Sciences

Bachelor's degree in chemical/biochemical/mechanical engineering or life sciences

Military technical training with supervisory experience

Associate's degree with 7+ years of related experience

High school diploma with 9+ years of related experience

2-4 years of people management experience

Experience operating DCS software (DeltaV / 800xA / Unicorn)

Tools

DeltaV

800xA

Unicorn

Job description

FUJIFILM Biotechnologies is seeking an Associate Manager of Manufacturing Downstream to lead a cross‑functional team on a 12‑hour day shift (7am–7pm). You will oversee chromatography and UFDF operations, coordinate with Process Science, OBX, MT&S, and ensure GMP compliance and inspection readiness across multiple clinical and commercial programs.

The role requires hands‑on bioprocessing experience, strong leadership, and the ability to mentor staff while driving continuous improvement in a