Associate Manager, Manufacturing Downstream (Days)

Fujifilm•Morrisville, NC

10d•Onsite

About The Position

The Associate Manager of Manufacturing Downstream leads daily manufacturing operations and a cross-functional team of technicians on a rotating 12-hour day shift, 7 a.m. to 7 p.m. The team performs recovery and chromatography processing using chromatography skids and UFDF skids in a regulated, fast-paced, modular multiproduct environment. The role supports manufacturing site KPIs and requires prior hands-on bioprocessing experience, operational leadership, and mentorship across clinical and commercial production phases. The position oversees downstream manufacturing campaigns for pre-clinical, Phase I–III clinical, PPQ, and commercial batches across multiple client programs. It coordinates staffing, production plans, equipment, materials, and supplies; maintains GMP and EHS compliance and inspection readiness; and serves as the shift’s primary contact for cross-functional teams. The role also supports audits, investigations, deviations, root cause analysis, CAPA, equipment lifecycle activities, technology transfer, and continuous improvement. It provides coaching and technical mentorship to direct reports and carries out administrative and employee-management responsibilities. The role is based at FUJIFILM Biotechnologies’ manufacturing site in the Morrisville/Research Triangle Park area of North Carolina. The work may require respiratory or hearing protection, working at heights, and physical activities including prolonged standing or sitting, climbing, repetitive hand and wrist motions, machinery operation, and moving objects up to 50 pounds.

Requirements

Master’s degree in an engineering discipline, life sciences, or another technical field and 3 or more years of related experience; or a bachelor’s degree in chemical, biochemical, or mechanical engineering, life sciences, or another technical field and 5 or more years of related experience; or military technical training in science, engineering, or another technical field and 5 or more years of supervisory experience in a related technical field; or an associate degree in a related technical field and 7 or more years of related experience; or a high school diploma and 9 or more years of related experience.
2–4 years of people management experience.
Experience operating distributed control system software such as DeltaV, 800xA, or Unicorn.
Knowledge of chromatography techniques, UFDF systems, and downstream single-use equipment.
Comprehensive knowledge of cGMP and EHS regulations.
Familiarity with production scheduling, planning, quality assurance practices, and audit processes.
Understanding of equipment lifecycle management and technology transfer principles.
Leadership ability to hire, coach, and develop individual contributors and teams, provide training, and resolve conflicts.
Strong technical aptitude, problem-solving skills, and in-shift troubleshooting capabilities for unit operations.
Effective written and verbal communication skills for presenting information and liaising with cross-functional teams.
Strong organizational skills and ability to manage multiple priorities.
Ability to foster a collaborative team environment and motivate and empower others.
Ability to maintain compliance and inspection readiness, execute production campaigns across phases, and achieve operational efficiency.
Focus on continuous improvement, adaptability to an evolving environment, and effective risk management.
Ability to handle emergency situations and build consensus among departments to streamline operations and decision-making.
Flexibility to support a 24/7 manufacturing facility.
Ability to work in environments that may require respiratory protection and in mechanical or production spaces that may require hearing protection and enrollment in a hearing conservation program.
Ability to discern audible cues, climb or descend ladders, scaffolding, and ramps, and stand or sit for prolonged periods of 60 minutes.
Ability to perform repetitive motions involving wrists, hands, or fingers; operate machinery or power tools; and move objects weighing up to 50 pounds.
Ability to work at heights greater than 4 feet.

Nice To Haves

Lean Six Sigma Yellow or Green Belt.
Bioworks, biomanufacturing, or relevant certificate.

Responsibilities

Manage daily and weekly operations, including shift scheduling, task delegation, and execution of production plans according to batch records and manufacturing standard of work.
Lead shift-level downstream manufacturing activities, including chromatography for mammalian and microbial fermentation operations and associated recovery operations.
Execute production campaigns supporting pre-clinical, Phase I–III clinical, PPQ, and commercial batches across multiple client programs.
Review production schedules in advance and ensure equipment, materials, and supplies are available to meet production needs.
Coordinate resources and communication across management and manufacturing to maintain adequate coverage and operational efficiency.
Serve as the primary shift contact for cross-functional teams and troubleshoot upstream operations and equipment, including fermentation, cell culture, and CIP/SIP, while maintaining inspection-ready manufacturing suites.
Enforce adherence to GMP, EHS, SOPs, and compliance requirements, including review of batch, formulation, and logbook records.
Participate in audits, regulatory inspections, and internal quality investigations as needed.
Initiate real-time deviations, escalate quality trends, process deviations, and equipment failures, and support investigations, root cause analysis, and CAPA implementation.
Collaborate with Process Science, Operational and Business Excellence, and Manufacturing Technology and Support on equipment lifecycle, technology transfer, and continuous improvement projects.
Administer company policies affecting employees, including time off, shift work, and inclement weather policies.
Complete administrative tasks such as timecard approvals, time-off approvals, and expense reports.
Coach and technically mentor direct reports to support their professional development, capabilities, and empowerment.
Recognize achievements, address performance gaps and employee concerns, and partner with HR as needed.
Align team efforts with organizational goals and assess development needs to improve team performance.