Scientist 2, Analytical Development Tech Transfer

Fujifilm

Posted on : 18-07-2025

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1 Vacancy

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Job Location

Holly Springs, MS - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 18-07-2025

Job Description

Position Overview

The Analytical Development (AD) Tech Transfer (TT) Scientist 2 manages and coordinates the transfer of drug substance and drug product QC analytical methods from customers into the large-scale manufacturing facility from first campaign through commercialization (clinical through process performance qualification/commercial). This role interfaces with customers and cross-functional teams to scope analytical testing plans and achieve project milestones. This role authors/reviews transfer plans method transfer documents transfer summary reports and specification justification reports as needed. This role effectively communicates and operates 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

Works with customers and the TT program to lead and manage the QC AD TT process

Supports analytical method TT and execution including method verification transfer and validation

Interfaces with customers and program management to identify analytical needs and performs risk and gap assessments during project scoping

Develops project plans that align with program scope and customer expectations

Ensures the analytical team understands business goals and customer expectations and delivers results according to project deadlines

Participates in regular meetings for TT programs with cross-functional teams and key stakeholders

Serves as the subject matter expert (SME) to review author and deliver SOPs transfer plans protocols reports and transfer summary reports

Liaises with Contract Laboratory Organizations (CLOs) QC testing teams Quality Assurance (QA) and Process Science groups to ensure prioritization of non-compendial and compendial method transfer activities according to deadlines

Collaborates with the LIMS team and IT department to build new analytical method functionality that meets end-user and customer requirements

Ensures compendial method oversight and scientific guidelines (e.g. ICH EMA FDA etc.)

Supports regulatory requests and inspections

Supports the QC AD team to investigate any project challenges with necessary risk assessment tools and techniques

Support best practices for TT and PPQ strategies globally as required

Performs other duties as assigned

Minimum Requirements:

B.S. in Chemistry Biochemistry Biological Sciences Engineering or related science field with 9 years of analytical laboratory experience preferably in biotechnology Pharma Contract Research Organization (CRO) or Contract Laboratory Organization (CLO)
4-6 years experience in a GMP environment

Preferred Requirements:

M.S. in Chemistry Biochemistry Biological Sciences Engineering or related science field with 7 years of experience OR
Ph.D. in Chemistry Biochemistry Biological Sciences Engineering or related science field with 5 years of experience
Experience with Customer Relationship Management
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)

Physical and Work Environment Requirements:

Will work in environment which may necessitate respiratory protection

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color.

Ability to stand for prolonged periods of time up to 120 minutes

Ability to sit for prolonged periods of time up to 120 minutes

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

Ability to conduct work that includes moving objects up to 10 pounds.

Will work in warm/cold environments

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 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 ().

Employment Type

Unclear

Company Industry

Department / Functional Area

Quality Control

Key Skills

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About Company

Fujifilm

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Scientist 2, Analytical Development Tech Transfer

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Department / Functional Area

Key Skills

About Company

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