The Head of OPEX is responsible for driving the development and execution of strategic operations plans that align with our overarching business objectives and manufacturing goals. This role involves close collaboration with leaders across all manufacturing value streams and Head of Operations to support process development and operational excellence initiatives.

The expert role provides guidance on process-driven methodologies, develops, and implements best practices, and ensures adherence through regular follow-ups and governance mechanisms. It focuses on enhancing efficiency and quality through increased standardization across manufacturing operations.

The role will lead operational excellence (OPEX) initiatives and maintain a consistent operational cadence for productivity and continuous improvement. This expert leads stakeholders to improve regulatory compliance, ensure FDA inspection readiness and implement core remediation efforts employing an approach that supports the team while respecting established processes.

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.

Essential Functions:

• Drive the development of strategic operations plans to align with business objectives and manufacturing goals, e.g. through:
• Driving KPI development and target setting
• Supporting cross-organizational initiatives with local implementation (e.g. by being responsible for the kojoX glide path)
• Support the Sales & Operations Planning (S&OP) process to help coordinate the efficient utilization of capabilities/capacity to serve customer needs.
• Collaborate closely with leaders across the manufacturing value streams to drive initiatives and support their organizational goals, involving topics related to process development and operational excellence.
• Provide expert guidance on working in a process-driven way to drive the definition and implementation of best practices across all three manufacturing value streams.
• Lead and support effort to further a standardized approach across all manufacturing operations to increase efficiency and quality.
• Develop and implement standardized best practice processes together with the manufacturing teams
• Ensure adherence throughout the manufacturing process, e.g. through developing and implementing regular follow-ups and governance mechanisms.
• Provide operational excellence (OPEX) leadership across the site, e.g. to:

• Drive continuous improvement initiatives to enhance operational efficiency, product quality, and safety.
• Lead efforts in VAVE (Value Analysis and Value Engineering), cost reduction, process development, and adherence to standard processes.
• Lead OPEX initiatives to drive efficiency and effectiveness across operations.

• Develop and maintain a cadence for operations that ensures consistent productivity and continuous process improvements.
• Oversee work related to regulatory requirements and inspections:
• Ensure the manufacturing team is prepared for FDA inspections by developing and implementing robust inspection readiness programs.
• Lead the preparations for scheduled FDA inspections, and support ongoing dialogues with FDA
• Lead and be accountable for overseeing core remediation efforts to ensure compliance with regulatory standards.

• All other duties as assigned.

Required Skills & Abilities:

• Strong project management skills, with the ability to handle multiple projects simultaneously.
• Excellent communication and interpersonal skills, with a collaborative approach to problem-solving.
• Proven experience in leading OPEX initiatives such as VAVE, cost out, and process development.
• In-depth understanding of regulatory requirements, including GMP, FDA, and EMA guidelines.
• Strategic thinker with a track record of driving process improvements.
• Proficiency in using data analytics tools and platforms to drive decision-making and process improvements.

Working Conditions & 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:

• Insert working conditions such as lifting requirements, required travel, etc.

• Onsite attendance.

Minimum Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Business Administration, or a related field and 12-15 Years of experience in operational excellence, process improvement, or related roles preferably within the biotech, pharmaceutical, or manufacturing industries.
• At least 8 years of management or supervisory experience.

Preferred Qualifications:

• Master’s degree or MBA is often preferred, especially with a focus on operations management, process engineering, or continuous improvement.

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.

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).