Scientist, QC Raw Materials Method Transfer & Validation

Fujifilm

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

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 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

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

Masters 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.

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.

*LI-Onsite

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 ().

Required Experience:

Position OverviewWe 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 closel...