Associate Manager, Manufacturing Upstream

FUJIFILM Diosynth Biotechnologies • Research Triangle Park, NC

71d

About The Position

The Associate Manager of Manufacturing leads daily manufacturing operations during a 12-hour shift. This position is responsible for managing a cross-functional team of technicians executing cell culture and microbial fermentation processes using both single-use technologies and stainless steel, 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.

Requirements

• Master's degree in an engineering discipline, Life Sciences, or other technical field with 3+ years of related experience; or
• Bachelor's degree in chemical, biochemical, mechanical engineering, life sciences or other technical field with 5+ years of related experience; or
• Military technical training in science, engineering, or other technical field with 5+ years of supervisory experience in a related technical field; or
• Associate's degree in chemical, biochemical, mechanical engineering, life sciences or other technical field with 7+ years of related experience; or
• High school diploma with 9+ years of related experience
• 2-4 years of people management experience
• Experience operating distributed control system (DCS) software, such as DeltaV, 800xA, or Unicorn
• Equipment-specific training on technologies related to a single-use and stainless-steel systems and processes
• CGMP certification or training

Nice To Haves

• Lean Six Sigma Yellow or Green belt
• Bioworks, Biomanufacturing or relevant certificate

Responsibilities

• 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 upstream manufacturing activities, including single-use cell culture processing for mammalian systems, 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 improvement projects to ensure operational success
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
• Serves as a coach and technical mentor for direct reports to foster professional development, enhance capabilities, and encourage empowerment
• Recognizes achievements, addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
• Supports departmental goals by aligning team efforts to organizational goals and assessing development needs to improve team performance
• Performs other duties, as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Master's degree