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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** _12 hours ago_ _(7/23/2025 12:33 PM)_

**_Requisition ID_** _2025-35133_

**_Category_** _Management_

**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_