About This Role

This role will manage the daily operations of the QC Sample Management team, responsible for the management of QC samples and materials in support of the QC laboratories. This includes, but is not limited to, mentoring, training and managing the QC Sample Management team, maintaining and tracking testing samples, retains, scheduling lab operations, supporting lot release, creating and continuously improving processes, reviewing and approving documents, and overseeing sample tracking, delivery, and destruction.

What You'll Do

Hiring team to support Sample Management and QC becoming operational ready and then transition to overseeing day-to-day activities to support routine operations
• During the project phase responsibilities may include authoring SOPs, defining team structure to support project timelines, operational readiness, and routine operations
• During project phase responsibilities may include set up of QC lab to support project timelines, getting the lab ready and transitioning the team to routine QC testing to support biological manufacturing
• Managing daily operations of the QC Sample Management team, this includes, but is not limited to, mentoring, training and managing the QC Sample Management team, maintaining and tracking testing samples, retains, scheduling lab operations, supporting lot release, creating and continuously improving processes, reviewing and approving documents, and overseeing sample tracking, delivery, and destruction of samples.
• Managing of QC samples and materials in support of the QC activities related to in-process, drug substance, and drug product release including chain of custody, label, receipt, storage, transfer, and disposal according to GMP requirements and approved procedures
• Develop and manage a daily work plan for Sample management team to ensure on time delivery to stakeholders in QC and across site
• Report out quality and operational metrics
• Review and approve procedures for Sample Management activities
• Cross-functionally collaborate with other departments to identify and implement process improvements and communicate effectively with management regarding task completion, roadblocks, and needs
• Own and evaluate relevant change controls, investigations, deviations, CAPAs
• Apply critical thinking skills when working on new procedures or process improvements
• Collaborating across different sites to align policies and best practices for instrument validation
• Responsible for team's annual operating budget and ensuring team maintains expenses to align with annual budget
• Perform other tasks as assigned

Minimum Requirements:

• Bachelor's degree required, preferably in Chemistry, Microbiology, Biological Sciences or related science degree OR Masters with 6+ years of experience OR Ph.D. with 3+ years of experience
• 8 years of relevant work experience, preferable in a regulated environment
• At least 2 years of management and people leader experience

Preferred Requirements:

• Experience with cold chain sample storage and transfer in a GMP regulated environment
• Familiar with Excel, Visio, Power Point, and other software systems.
• Experience with laboratory LIMS and ERP systems (e.g., SAP) preferred.

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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.