Position Overview
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.
Job Description
What You'll Do
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
Knowledge and Skills
Knowledge of bioprocessing techniques, including cell culture and microbial fermentation, using single-use and stainless-steel technologies
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 team, providing training and resolving conflicts
Strong technical aptitude and problem-solving skills with in-shift troubleshooting capabilities for unit operations
Effective communication, both written and verbal to effectively present information and liaise with cross-functional teams
Proficient using Microsoft Office Suite (Word, Excel, PowerPoint) for data gathering, entry, and reporting
Strong organizational skills and ability to manage multiple priorities
Ability to foster a collaborative team environment, including motivating and empowering others
Ability to maintain compliance and inspection readiness, execute production campaigns across various phases, and achieve operational efficiency
Strong focus on continuous improvement, ability to adapt to an evolving environment, and effective risk management
Ability to handle emergency situations and build consensus among departments to streamline operations and decision-making
Must be flexible to support 24/7 manufacturing facility
Basic Requirement
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
Preferred Requirements
Lean Six Sigma Yellow or Green belt
Bioworks, Biomanufacturing or relevant certificate
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Will work in environment which may necessitate respiratory protection. No X Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
Ability to discern audible cues. No X Yes
Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. No X Yes 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. No X Yes 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 50 lbs.
Job Locations US-NC-Research Triangle Park
Posted Date 2 days ago (7/23/2025 12:33 PM)
Requisition ID 2025-35133
Category Management
Company (Portal Searching) FUJIFILM Biotechnologies
