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As the Associate Director of Microbiology, you will play a pivotal role in overseeing all microbiological testing and ensuring the highest standards of quality, data integrity, and compliance at our manufacturing site. You will leverage your expertise to guide our efforts in maintaining a contamination-free environment, support our product pipeline, and ensure regulatory compliance.

Company Overview

The work we do at FUJIFILM Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki.

Our state-of-the-art biomanufacturing facility is located in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation.

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:

Job Description

Reports to Head of Quality Control

Work Location College Station, TX

Responsibilities

• Microbial Testing Oversight: Lead and manage all aspects of microbiological testing, including sterility, bioburden, endotoxin testing, and environmental monitoring for our manufacturing processes.
• Quality Assurance: Develop and implement microbiological quality control procedures to ensure compliance with FDA, EMA, and other relevant regulatory guidelines.
• Data Integrity: Ensure all microbiological data is complete, accurate, and securely maintained. Uphold the integrity of all lab records and ensure compliance with ALCOA++ principles.
• Team Leadership: Manage and mentor a team of microbiology professionals, fostering a positive and collaborative work environment.
• Process Improvement: Identify opportunities for process enhancements and innovation in microbiological testing methods to increase efficiency and accuracy.
• Risk Assessment: Collaborate with site's contamination control expert to conduct risk assessments and implement risk mitigation strategies related to microbial contamination in manufacturing processes.
• Regulatory Compliance: Prepare for and participate in internal and external audits, providing expertise and ensuring all microbial testing meets regulatory standards.
• Cross-Functional Collaboration: Work closely with the Quality Assurance, Manufacturing, and Regulatory Affairs teams to support product development and ensure seamless operations.
• Documentation and Reporting: Ensure accurate documentation of all microbial testing activities and results, providing clear and comprehensive reports to senior management.
• Technology Adoption: Stay updated with the latest advancements in microbiology testing technologies and incorporate relevant innovations into existing processes.
• All other duties as assigned.

Qualifications

• PhD in Microbiology, Biology, or a related field and 4+ years of relevant experience in biopharmaceutical manufacturing; OR,
• Master's degree in Microbiology, Biology, or a related field and 7+ years of relevant experience in biopharmaceutical manufacturing; OR,
• Bachelor's in Microbiology, Biology, or a related field and 9+ years of relevant experience in biopharmaceutical manufacturing.
• 5 years of experience in a leadership role required.
• Experience in a CDMO environment is highly desired.
• Proven experience managing microbiology laboratories and leading teams in a manufacturing environment.
• In-depth knowledge of regulatory guidelines, quality systems, and data integrity principles including cGMP and ALCOA++.
• Strong problem-solving skills and a proactive approach to identifying and mitigating microbial risks.
• Exceptional communication and leadership skills, with the ability to work effectively in a cross-functional team setting.
• Demonstrated ability to manage multiple projects and priorities in a fast-paced environment.
• Role model for company core values of trust, delighting our customers, and Gemba.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping, and stretching.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
• Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
• Lifting up to 25 pounds on occasion.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Must be willing to work flexible hours as needed.
• Onsite attendance is required.

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 (...@fujifilm.com or (979) ###-####).

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Research, Analyst, and Information Technology

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