Senior Specialist II, Tech Support & Sample Support

The QC Program Management Technical Support (TT) and Sample Support (SS) Senior Specialist 2 provides technical leadership through effective project management of the QC Sample Plans, QC Specifications, stability protocols, stability reports, stability sample pull scheduling, and stability specifications in close collaboration with relevant stakeholders and customers. This role helps ensure the timely completion of project milestones and deliverables, supports GMP compliant laboratory operations in accordance with regulatory guidelines, and participates in audits and inspections. As representative of QC, the TT/SS Senior Specialist 2 interfaces with customers to scope QC Sample

Plans, QC Specifications and stability studies as well as participates in and leads collaborations with cross-functional teams., * Works in collaboration with customers and stakeholders from QC, Drug Substance Manufacturing (DSM), and Drug Product (DP)

fill/finish to support tech transfers of new customer projects as they relate to QC Sample Plans, Stability studies, and DS/DP

Specifications

• Authors, reviews, and leads updates of controlled GMP documents related to QC Sample Plans, QC Specifications, Stability protocols,

reports, and stability specifications

• Leads, authors, and reviews change controls of QC Sample Plans and stability protocols for both internal and external changes

together with relevant stakeholders, including communication with customers as applicable

• Manages and directs the continuous improvement of QC Sample Plans and QC Specifications

• Applies a holistic quality system approach through identifying and solving technical compliance gaps and areas for improvement or

remediation related to quality or process; leads through completion and sustainable implementation

• Leads/participates in team compliance activities including writing, changing, and maintaining GMP documents in collaboration with

relevant stakeholders and QA

• Ensures compliance with platform, procedures, and global QC vision

• Supports management in training compliance with policies and inspections

• Supports regulatory requests, audits, and inspections

• Collaborates with the Laboratory Information Management System (LIMS) team and IT department to build DS/DP sample plan,

specification, and stability functions that meet end-user and customer requirements

• Provides guidance and feedback for QC personnel development

• Performs other duties as assigned

• Bachelor’s degree in Microbiology, Virology, Biology,

Chemistry, Biochemistry, Biological Sciences, Engineering, or

related science field with 5+ years of experience; OR

• Masters degree in Virology, Microbiology, Biology, Chemistry,

Biochemistry, Biological Sciences, Engineering, or related

science field with 3+ years of related experience; OR

• Ph.D. in Virology, Microbiology, Biology, Chemistry,

Biochemistry, Biological Sciences, Engineering, or related science field with 0+ years of related experience

• 5+ years of project management experience

• 1-3 years of experience in a GMP environment

• 2-3 years of Stability study management and protocol issuance

• Experience with customers and tech transfers

Preferred Requirements:

• 5+ years of project management experience in biotechnology,

Pharma, Contract Research Organization (CRO), or Contract

Laboratory Organization (CLO)

• Experience with Customer Relationship Management

• Drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting

• Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system)

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

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: https://www.fujifilm.com/us/en/about/region/careers