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 using chromatography and UFDF skids, and has a direct impact on manufacturing site key performance indicators. It combines hands-on bioprocessing knowledge with operational leadership and mentorship across clinical and commercial production phases. The position manages shift scheduling, task delegation, production plans, resources, and production supply needs. It leads downstream activities for mammalian and microbial fermentation operations and supports campaigns spanning pre-clinical, Phase I–III clinical, PPQ, and commercial batches. The role is the primary shift contact for cross-functional teams and troubleshoots upstream operations and equipment as needed, while maintaining inspection-ready manufacturing suites and compliance with GMP, EHS, SOPs, and documentation requirements. The Associate Manager supports audits, regulatory inspections, quality investigations, deviations, root cause analysis, and CAPA implementation. The role collaborates on equipment lifecycle management, technology transfer, and continuous improvement; administers employee policies and routine administrative tasks; and coaches and develops direct reports. The position follows a rotating 12-hour day schedule, 7 a.m. to 7 p.m., and must be flexible to support a 24/7 manufacturing facility.

Requirements

Master’s degree in an engineering discipline, life sciences, or another technical field with at least 3 years of related experience; or bachelor’s degree in chemical, biochemical, or mechanical engineering, life sciences, or another technical field with at least 5 years of related experience; or military technical training in science, engineering, or another technical field with at least 5 years of supervisory experience in a related technical field; or associate’s degree in a related technical field with at least 7 years of related experience; or high school diploma with at least 9 years of related experience.
2–4 years of people management experience.
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 leadership ability to hire, coach, and develop individual contributors and teams, provide training, 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, execute campaigns across production 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.
Experience operating distributed control system software such as DeltaV, 800xA, or Unicorn.
CGMP certification or training.

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 standards of work.
Lead shift-level downstream manufacturing, including chromatography for mammalian and microbial fermentation operations and associated recovery operations.
Execute production campaigns for pre-clinical, clinical (Phase I–III), PPQ, and commercial batches across multiple client programs.
Plan ahead for manufacturing needs by reviewing schedules and ensuring equipment, materials, and supplies are available for production.
Coordinate resources and communication across management and manufacturing to support 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.
Keep manufacturing suites inspection-ready and enforce adherence to GMP, EHS, SOPs, and documentation 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, OBX, MT&S, and other teams on equipment lifecycle, technology transfer, and continuous improvement projects.
Administer employee policies related to time off, shift work, and inclement weather, and complete administrative tasks such as timecard and time-off approvals and expense reports.
Coach and technically mentor direct reports, 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.