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.

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FUJIFILM Diosynth Biotechnologies call Genki. 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Reports to                Head of Quality Control

Work Location         College Station, TX 

Primary 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:

• D. 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, Gemba, and Genki.

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.

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.

*LI-Onsite

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.

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 (FDBTHR@fujifilm.com or (979) 431-3500).