Associate Manager, Manufacturing Upstream

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 (10 / 15 / 2025 9 : 58 AM)

Requisition ID 2025-35133

Category Management

Company (Portal Searching) FUJIFILM Biotechnologies