Manager, DPFG MSAT

Position Overview

The Manager, Drug Product Finished Goods (DPFG) MSAT is the process owner and focuses on DPFG manufacturing. This role sets up and maintains cGMP Aseptic operations and processes for integrating finished goods into the site. During the project phase, leads projects and owns the technical transfer set up and initiation for DPFG. The Manager, DPFG MSAT works closely with the commissioning, qualification and validation (CQV) organization to ensure all equipment and processes are established and aligned, leads projects to create new processes and expands the capabilities and functionalities into operations. This role supports the Global team providing subject matter expertise level inputs for drug product and finished goods group and ensures the business processes are in place.

Company Overview

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:

Job Description

What You'll Do

• Manages, leads and develops a team of DPFG MSAT engineers and technical transfer associates
• Manages a team to lead, develop and implement scientifically sound and fit for purpose policies and procedures based on current regulations, industry standards and industry practices for drug product manufacturing, process and technology transfer, and process validation
• Provides cross-functional leadership/support to the manufacturing site to refine the process requirements for execution
• Continuously seeks to optimize the manufacturing processes to ensure effective use of capacity and minimize costs
• Partners with Client, Program Design, Quality, Manufacturing and Engineering on platform development, technology innovation, scale-up, and manufacturability as part of technology transfers, as needed
• Leads/supports assessments and recommends new equipment/platforms which improves manufacturing processes from a cost, efficiency, quality,
  and compliance perspective
• Performs tech transfer stage gate reviews on incoming processes/changes to ensure the change is ready for introduction to Manufacturing ensuring
  manufacturability of the process
• As technical steward, provide oversight for a robust technical transfer execution and manufacturing support throughout the production lifecycle of manufacturing processes
• Supports the CMC review of regulatory submissions, manufacturing site inspections and health authority inquiries
• Provides team support for critical manufacturing investigations and technical oversight of deviations, change controls and CAPA's
• Resolves technical problems through scientific understanding and application of innovative solutions
• Provides team support for investigations, root cause analysis, and optimization with data support and analysis
• Leads team in curating critical knowledge and developing best practices in DPFG manufacturing
• Coaches and mentors direct reports and team members to foster professional development and growth
• Enforces and ensures team adheres to company policies and procedures
• Evaluates team performance and address gaps appropriately
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
• Coaches and guides direct reports to foster professional development
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed
• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
• Performs other duties, as assigned

Minimum Requirements:

• Bachelor's degree in Life Sciences, Engineering or related field with 10+ years of CMC experience leading pre-approval and post-approval activities for biologic product, including process development and/or GMP manufacturing
• Prior DPFG development and manufacturing experience, including process validation, process transfer, commercialization, and manufacturing support and troubleshooting
• 2-3 years of Leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Requirements:

• Master's degree in a scientific or engineering field
• Previous drug product, isolator start-up experience
• Experience communicating and collaborating cross-functionally
• Global Collaboration Experience

Working Conditions & Physical Requirements:

• Ability to stand for prolonged periods of time, up to 60 minutes
• Ability to sit for prolonged periods of time, up to 60 minutes

*#LI-Onsite

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.

EEO Information

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.

ADA Information

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 ([email protected]).