Associate Manager, Manufacturing Downstream (Days)

Fujifilm•Research Triangle Park, NC

8d•Onsite

About The Position

The Associate Manager of Manufacturing Downstream leads daily downstream manufacturing operations and a cross-functional team of technicians in a regulated, client-facing, modular multiproduct environment. The role oversees Recovery and Chromatography processing, including Chromatography and UFDF systems, and supports production across pre-clinical, clinical (Phase I–III), PPQ, and commercial campaigns. The position contributes directly to manufacturing site KPIs and requires hands-on bioprocessing knowledge, operational leadership, and mentorship across production phases. This role works a rotating 12-hour day schedule, 7 a.m.–7 p.m., in a 24/7 manufacturing facility. The manager coordinates production schedules, people, equipment, materials, and supplies; maintains GMP, EHS, and inspection-readiness standards; collaborates with cross-functional groups on equipment lifecycle management, technology transfer, and continuous improvement; and coaches and develops direct reports. The position is based at FUJIFILM Biotechnologies’ site near Morrisville and Research Triangle Park, North Carolina. The work may involve respiratory and hearing protection, work at heights, prolonged standing or sitting, repetitive hand and wrist motions, operating machinery and power tools, climbing, and moving objects up to 50 pounds.

Requirements

Master’s degree in engineering, life sciences, or another technical field and 3 or more years of related experience; or 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 associate’s degree in a related technical field and 7 or more years of related experience; or high school diploma and 9 or more years of related experience.
2–4 years of people management experience.
Experience operating distributed control system (DCS) 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.
Demonstrated ability to hire, coach, train, and develop individual contributors and teams, and resolve conflicts.
Strong technical aptitude and problem-solving skills, including in-shift troubleshooting of 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, motivate and empower others, maintain compliance and inspection readiness, and execute production campaigns across phases.
Focus on continuous improvement, adaptability to an evolving environment, and effective risk management.
Ability to handle emergency situations and build consensus among departments.
Flexibility to support a 24/7 manufacturing facility.
CGMP certification or training.
Ability to meet the physical and environmental demands of the role, including respiratory or hearing protection when required, discerning audible cues, climbing, prolonged standing or sitting, repetitive motions, operating machinery or power tools, moving objects up to 50 pounds, and working 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 activities, including mammalian and microbial fermentation Chromatography and associated recovery operations.
Execute production campaigns for pre-clinical, clinical (Phase I–III), 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 teams to ensure coverage and operational efficiency.
Serve as the shift’s primary point of contact for cross-functional teams and troubleshoot upstream operations and equipment, including fermentation, cell culture, and CIP/SIP.
Ensure manufacturing suites remain inspection ready and enforce adherence to GMP, EHS, SOPs, and documentation requirements.
Review GMP documentation, including 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, OBX, MT&S, and other groups 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 and time-off approvals and expense reports.
Coach and technically mentor direct reports, support professional development and training, recognize achievements, address performance gaps and employee concerns, and partner with HR as needed.
Align team efforts with departmental and organizational goals and assess development needs to improve team performance.
Support a 24/7 manufacturing facility and handle emergency situations while building consensus across departments.