Associate Manager - Manufacturing Downstream

Position Overview

The Associate Manager of Manufacturing Downstream leads daily manufacturing operations during a 12-hour shift (Days - 7am - 7pm). This position is responsible for managing a cross-functional team of technicians executing Recovery and Chromatography processing using Chromatography skids and UFDF skids, 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.

Shift: Rotating 12-hour schedule 7am - 7pm

Company Overview

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

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 Downstream manufacturing activities, including Chromatography for mammalian and 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).
• 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.

Knowledge, Skills, and Abilities: 

• 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 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
• 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
• Chromatography techniques, UFDF systems, and Downstream single use equipment.
• CGMP certification or training

Education & Experience Requirements: 

• 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

Preferred Training & Experience: 

• Lean Six Sigma Yellow or Green belt
• Bioworks, Biomanufacturing or relevant certificate

Physical Requirements:

• Work in environment which may necessitate respiratory protection
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
• Ability to discern audible cues.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand or sit for prolonged periods of time (60 minutes)
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• Ability to operate machinery and/or power tools. 
• Ability to conduct work that includes moving objects up to 50lbs. 
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Environmental Conditions: 

• Will work in heights greater than 4 feet. 

Benefits:

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth! 

*#LI-Onsite

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).