Associate Director, Quality Control (Microbiology)

About the role

The Associate Director, Quality Control (Microbiology) is responsible for the effective management of the Quality Control Microbiology team to assure on time analysis of manufactured product and environmental monitoring samples. Responsible to assure all testing is performed in compliance with applicable regulations, company specifications, procedures, and policies at Fujifilm Diosynth Biotechnologies. The Associate Director, Quality Control (Microbiology) is the site SME for Microbiology, with oversight of microbial and environmental control in the manufacturing facility.

Responsibilities

• Creates a safe working environment within QC through a culture of behavioral safety and adherence to site EHS policies and procedures.
• Ensures team are actively engaged in the on-time delivery of routine operations and annual objectives.
• Maintains the QC Laboratories in a state of audit readiness, presents on QC topics and leads tours for client and regulatory inspections.
• Manages the team for excellence in laboratory investigations, on time completion of CAPA and Change Control.
• Oversight of microbial and environmental control in the manufacturing facility.
• Champion for Continuous Improvement providing the resources and developing the team to evaluate and improve upon current state.
• Invested in the development and actively manages performance of individuals.
• Adherence to QC expense and capital budget.
• Supervise 10 or more exempt or non-exempt staff.
• Contribute to the development of the capital and expense budget and have approval authorities as defined in the company's authorization matrix.
• Manage the department activities in a manner that meets or exceeds the company objectives regarding revenue, profit plan, supply, and compliance.

Requirements

• Bachelor of Science in Microbiology or related technical field and 12+ years of experience.
• Knowledge and experience of Bioburden, endotxin and EM testing.
• PREFERRED QUALIFICATIONS: Master's of Science and 10+ years OR PhD and 8+ years of experience in GMP laboratory environment.
• 5 years of supervisory experience.
• Experience working in a lean manufacturing or six sigma environment.
• Experience with LIMS and other data management systems.

Qualifications

• Demonstrated leadership, technical aptitude, and problem-solving skills.
• Adaptable and able to manage and prioritize multiple tasks and assignments.
• Excellent verbal and written communication skills and comfortably and clearly articulate issues with peers and colleagues at all levels in the organization.
• Demonstrated capability in a cross-functional team environment, working cooperatively with others in effective ways that attain goals while encouraging teamwork and synergies throughout the organization.
• Proficient technical writing skills.
• Able to make informed and timely decisions independently.
• Capable of recognizing process gaps and implementing improvements.
• Demonstrated leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization.
• Strong team skills, including the ability to coach/develop work teams, provide training, motivate/empower others, and resolve.
• Goal-oriented and able to manage risks.

Skills and Competencies

• Ability to stand for prolonged periods of time.
• Ability to sit for prolonged periods of time.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.

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.

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.

Job Description

To contribute to the development of the capital and expense budget and have approval authorities as defined in the company's authorization matrix. Manage the department activities in a manner that meets or exceeds the company objectives regarding revenue, profit plan, supply, and compliance.