Tech Transfer Lead

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

The tech transfer role includes the management and coordination of activities for products transferred into large scale manufacturing facility from first campaign through commercialization (clinical through process performance qualification/commercial). This involves managing between different teams ensuring compliance with regulations and optimizing processes for efficient transfer of knowledge and technology.

Company Overview

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

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What Youll Do

Leads and supports technology transfer (TT) across multiple unit operation
Coordinates and leads regular meetings for TT programs with key stakeholders
Develops process performance qualification (PPQ) strategies specific for each program in collaboration with internal stakeholders and customers
Develops project plans that integrates with other scheduling functions within the organization and in alignment with program scope
Escalates risks and tracks milestone progress and ensure cross functional communication to key stakeholders
Supports Chemistry Manufacturing and Control (CMC) activities for development and manufacturing as required
Supports the technical team to investigate any project challenges with necessary risk assessment tools and techniques
Reviews and documents process performance and product health through process trending monitoring and supporting annual product reviews
Serves as point of contact to customer and internal regulatory team for technical aspects of the program
Identifies continuous improvements opportunities
Supports best practices for TT and PPQ strategies globally as required
Coordinates plans and supports manufacturing process validation runs
Facilitates technical risk assessments for new manufacturing processes
Contributes to the management of manufacturing data (e.g. databasing) and the statistical analysis aimed at both process monitoring and continued process verification
Writes documentation for internal and external use such as manufacturing campaigns summary reports PPQMP (Process Performance Qualification Master Protocol and reports impact assessments etc.
Interprets and utilizes new knowledge to promptly drive data-based decisions
Collaborates with manufacturing department to support commercial and clinical manufacturing campaigns
Other duties as assigned

Minimum Requirements

Bachelors degree in engineering Life Science or Chemical Engineering with 5 years of relevant experience (e.g. manufacturing); or
Masters degree with 3 years of experience; or
PhD with no prior experience

Preferred Requirements

Experience working in a Good Manufacturing Practices (GMP) environment
Prior 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)
Experience with root cause analysis (RCA) and risk management tools

Working & Physical Conditions

Ability to discern audible cues.

Ability to conduct activities using repetitive motions that include writs hands and/or fingers.

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 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 committedto 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 ().

Position OverviewThe tech transfer role includes the management and coordination of activities for products transferred into large scale manufacturing facility from first campaign through commercialization (clinical through process performance qualification/commercial). This involves managing betwee...