Associate Manager, Manufacturing Downstream

The Associate Manager of Manufacturing Downstream leads daily manufacturing operations during a 12-hour shift (Days - 7am - 7pm). This position is responsible for managing a cross-functional team of technicians executing Recovery and Chromatography processing using Chromatography skids and UFDF skids, ensuring compliance and efficiency in a fast-paced, modular multiproduct environment. This role has direct impact on the delivery of manufacturing focused site key performance indicators (KPIs).

Additionally, this role incorporates prior hands‑on bioprocessing experience, thrives in a regulated and client‑facing environment, and demonstrates operational leadership and mentorship across varying clinical and commercial production phases.

Shift: Rotating 12‑hour schedule 7am - 7pm

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life‑impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP‑compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.

Situated at the cross‑section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

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:

• Manages daily and weekly operations, including shift scheduling, task delegation, and execution of production plans per batch records and manufacturing standard of work.
• Leads all shift‑level Downstream manufacturing activities, including Chromatography for mammalian and microbial fermentation operations, and associated recovery operations.
• Executes production campaigns supporting pre‑clinical, clinical (Phase I‑III), PPQ, and commercial batches across multiple client programs.
• Ensures equipment, materials, and supplies are available and successful delivery upon production supply schedule by proactively reviewing the schedule in advance to plan for manufacturing needs.
• Coordinates resources and facilitates effective communication across management and across manufacturing to ensure adequate coverage and operational efficiency.
• Serves as the primary point of contact during shift for cross‑functional teams, troubleshoots upstream operations and equipment (including fermentation, cell culture, CIP/SIP, etc.) while ensuring manufacturing suites remain inspection ready.
• Enforces team adherence to Good Manufacturing Practice (GMP), Environmental Health and Safety (EHS), standard operating procedures (SOPs) and compliance through GMP documentation review (including batch, formulation, and logbook records).
• Participates in audits, regulatory inspections, and internal quality investigations, as needed.
• Initiates real‑time deviations, escalates quality trends, process deviations or equipment failures, and supports related investigations or root cause analysis (RCA) and corrective and preventive action (CAPA) implementation.
• Collaborates cross‑functionally (e.g., Process Science, Operational and Business Excellence (OBX), Manufacturing Technology and Support (MT&S)) for equipment lifecycle, technology transfer, and continuous…