Downstream Manufacturing Shift Lead (12hr) – GMP Mentorship

FUJIFILM Biotechnologies; Durham (NC); Presencial; USD 120.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision coverage

401(k) with company match

Paid vacation and holidays

Life/work balance programs

Descripción de la vacante

FUJIFILM Biotechnologies is seeking an Associate Manager of Manufacturing Downstream to lead a cross‑functional team in a fast‑paced, modular multiproduct facility. The role covers 12‑hour day shifts and oversight of Chromatography and UFDF processing with strong focus on GMP and EHS adherence.

You will drive production campaigns for multiple client programs, mentor engineers, and ensure inspection readiness while coordinating with Process Science, MT&S, and OBX teams across phases from

Formación

• Strong knowledge of Chromatography techniques and UFDF systems used in downstream processing.
• Familiarity with CGMP/EHS regulations and audit processes.
• Experience leading cross-functional teams in a regulated bioprocess environment.

Responsabilidades

• Manage daily/weekly operations, shift scheduling, and batch record execution.
• Lead downstream activities including chromatography and recovery operations.
• Coordinate resources and ensure on‑time production per schedule and SOPs.
• Coach and mentor direct reports; drive continuous improvement and CAPA.
• Support audits, regulatory inspections, and investigations as needed.

Conocimientos

Chromatography

UFDF systems

Downstream processing

Leadership

GMP compliance

EHS compliance

Troubleshooting

Educación

Master’s degree in engineering or life sciences

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

Herramientas

DeltaV DCS

Unicorn

Descripción del empleo

FUJIFILM Biotechnologies is seeking an Associate Manager of Manufacturing Downstream to lead a cross‑functional team in a fast‑paced, modular multiproduct facility. The role covers 12‑hour day shifts and oversight of Chromatography and UFDF processing with strong focus on GMP and EHS adherence.

You will drive production campaigns for multiple client programs, mentor engineers, and ensure inspection readiness while coordinating with Process Science, MT&S, and OBX teams across phases from