Scientist, QC Raw Materials - Method Transfer & Validation

NCBiotech; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, North Carolina is seeking a scientist with hands-on experience in raw materials and primary packaging for drug product manufacturing to support the QC Raw Materials group and readiness of the DP facility. You will contribute to tech transfers for new customers and their products at FUJIFILM Biotechnologies.

You will collaborate with a small team to enable drug product readiness, author testing strategies and SOPs, and interact with customers during tech

Qualifications

• Master's degree in Life Sciences or Engineering with GMP QA experience.
• Experience in GMP environment and pharmaceutical quality systems.
• Experience with regulatory requirements for materials (cGMPs, USP, EP, JP, ICH).

Responsibilities

• Author testing strategies, specifications for primary packaging materials and raw materials used in DP manufacturing.
• Write and update SOPs within DS and DP material areas.
• Represent QC Raw Materials in Tech Transfer projects and customer interactions.

Skills

Regulatory knowledge

Quality control

Regulatory interpretation

Technical writing

Stakeholder management

Education

Master's degree in Life Sciences or Engineering

Tools

Microsoft Office

Smartsheet

LIMS

SAP ERP

Job description

Position Overview

We are looking for a scientist with experience with raw materials and specific primary packaging for drug product manufacturing. We are looking for a structured, pragmatic and diplomatic person that can support the drug product area within QC Raw Materials. You will be working closely with the small team handling materials to enable the readiness of the drug product facility. Additionally, you will be involved in tech transfers for new customers and their products at FUJIFILM Biotechnologies.

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 challenge status quo. 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

• Authoring testing strategies, specification justifications and corresponding specifications for primary packaging materials, disposables and raw materials used in the DP manufacturing processes and any devices to be used together with the product.
• Writing and updating SOPs within the DS and DP material area.
• Representing QC Raw Materials in Tech Transfer projects, including customer interactions.
• Focus on continuous improvements to all our processes and challenge status quo.
• Performs other duties as assigned.

Knowledge, Skills, or Abilities

• Displays an advanced knowledge of regulatory requirements for materials (e.g., cGMPs, USP, EP, JP, and ICH).
• Possesses a broad knowledge of quality control operations, systems, and directives.
• Ability to challenge and interpret regulations with scientific confidence and sound risk-based judgement.
• Demonstrates excellent technical writing skills, and clear oral and written presentation abilities.
• Strong stakeholder management and communication skills, enabling alignment across sites and global functions.

Minimum Qualifications

• Master's degree in Life Sciences or Engineering and 4+ years of experience in GMP quality assurance and/or similar role.
• 5+ years of experience within the pharmaceutical industry, preferably within the field of starting materials and primary packaging.

Preferred Qualifications

• Preferable experience from similar role.
• 2+ years of experience with customer meetings and audit/inspections.
• 5+ years of experience in a GMP environment.
• Experience with Microsoft Office, Smartsheet, LIMS and ERP systems (e.g., SAP).

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:

• May work in Mechanical/Production spaces that may require hearing protection and enrollment in hearing conservation program.
• Ability to stand for prolonged periods up to 60 minutes.
• Ability to sit for prolonged periods up to 30 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.

*LI-Onsite

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]).