Scientist 1, Global QC Analytical Development Raw Materials

Lensa; Holly Springs (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in biopharmaceuticals seeks a Scientist 1 for Global QC Analytical Development Raw Materials. This role involves method transfer and compliance oversight, requiring a strong background in GMP environments. Join a dynamic team in Holly Springs, NC, and contribute to innovative healthcare solutions.

Qualifications

• 5+ years’ experience in a GMP environment or 3+ years with a Master's.
• Experience with method transfers and regulatory compliance.

Responsibilities

• Coordinate transfer of analytical methods for raw materials.
• Ensure compliance with GMP regulatory guidelines.
• Engage with customers and manage raw material implementation.

Skills

Analytical Method Transfer

GMP Compliance

Problem Solving

Technical Support

Education

Bachelor’s or Master’s in Chemistry, Biochemistry, Microbiology

PhD in relevant scientific discipline

Job description

Scientist 1, Global QC Analytical Development Raw Materials

Scientist 1, Global QC Analytical Development Raw Materials

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Lensa is the leading career site for job seekers at every stage of their career. Our client, FUJIFILM Corporation, is seeking professionals in Holly Springs, NC. Apply via Lensa today!

Position Overview

The Scientist 1, Global QC Analytical Development Raw Materials is responsible for coordinating the transfer of analytical methods for raw materials into the FUJIFILM Biotechnologies Diosynth Quality Control Laboratory and external contract laboratory organizations (CLOs). This role liaises with customers, CLOs, QC testing teams, and QA groups to plan and track QC raw materials readiness for clinical and commercial manufacturing, which includes ensuring

training needs, internal procedures, specifications, and protocols are met. This role ensures compliance with all GMP (Good Manufacturing Practices)

regulatory guidelines.

Company Overview

FUJIFILM Diosynth 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

Job Description

What You'll Do

• Serves as a subject matter expert (SME) in cross-functional teams to assess testing approaches, determine internal and external laboratory verification and validation needs, and provide technical support for troubleshooting new material testing investigations
• Represents Global QC Analytical Development on internal and external tech transfer meetings related to the introduction of new materials for the manufacture of biological drug substances and drug products
• Engages with customers about customer controlled and Fujifilm Diosynth Biotechnologies controlled materials
• Creates overviews, tracks and manages activities for raw material implementation (test strategy, test site, method transfer plan), providing clear timelines and progress updates to stakeholders
• Performs change control assessment activities for tech transfers, including handling changes from customers on customer-controlled materials, and onboarding new and generic raw materials, consumables, test laboratories, and specifications
• Transfers analytical methods for testing and disposition of incoming raw materials and components according to specifications and procedures
• Develops plans and monitors progress for incoming and ongoing change controls for program items and vendor change notifications
• Authors, reviews, and approves analytical method transfer plans, documents and reports (specification justification reports (SJRs) and transfer summary reports (TSRs) for compendial and non-compendial methods, and change control assessments to support tech transfer activities
• Provides RM testing compendial method oversight and ensure compliance with GMP guidelines, e.g. ICH, EMA, FDA, etc.
• Supports and participates in regulatory audits and client inspections
• Leads cross-functional collaboration with QC Analytical Development, QC Program Management, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives
• Provides technical expertise on investigations for Out of Specification (OOS) results
• Provides support and guidance to internal QC stakeholders
• Performs other duties as assigned
  
  

Minimum Requirements

• Bachelor’s Master’s in chemistry, Biochemistry, Microbiology orother relevant scientific discipline with 5+ years’ experience OR
• Master’s in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 3+ years’ experience OR
• PhD with 1+ years of applicable industry experience
• 4-6 years of experience in a federally regulated GMP environment
• 4+ years’ experience in a GMP environment
• Experience with method transfers
  
  

Preferred Requirements

• In-depth knowledge of Raw Material methodology as it pertains to cGMP
• Experience in assay troubleshooting and problem solving
  
  

Physical And Work Environment Requirements

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 240 minutes.

Ability to sit for prolonged periods of time up to 240 minutes.

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

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

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.

Will work in warm/cold environments (5 C)

Will work in small and/or enclosed spaces.

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 ([e-mail]).

Job Locations US-NC-Holly Springs

Posted Date 1 month ago (4/16/2025 4:24 PM)

Requisition ID 2025-34280

Category Quality Control

Company (Portal Searching) FUJIFILM Diosynth Biotechnologies

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  IT Services and IT Consulting

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