Sr. Scientist 2, Material Science

Fujifilm

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

The Sr Engineer or Scientist of Material Science 1 manages the design and development of new single-use consumables in conjunction with our manufacturing teams. This role manages the leachable and extractables program including organizing testing and creating a data library based on products evaluated. This role also supports manufacturing investigations involving items such as: raw material variability and concerns consumable issues particle sources and provides impact assessments in collaboration with other Process Science subject matter experts (SMEs). Additionally this role writes investigation reports and leachable and extractable reports. The Sr Engineer or Scientist is the SME for customer and regulatory audits and
articulates the Fujifilm Biotechnologies procedures practices and rationale.

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

Provides oversight and supports the team with the introduction of new raw materials and associated document requirements
Ensures regulatory compliance assesses vendor change notifications and provides strategic input on raw materials related matters
Oversees and supports change requests for introduction modification and discontinuation of raw materials
Acts as a scientific liaison between Quality Control (QC) Supply Chain Manufacturing and Quality to assess material and supplier risks (e.g. supplier technical evaluations risk assessments raw material evaluation and qualification and new product introductions)
Develops and implements training for manufacturing staff on process improvement initiatives as needed
Leads or coordinates troubleshooting process impact assessments and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations related to materials used in manufacturing as needed
Delivers documentation for internal and external use such as comprehensive written protocols and reports summarizing investigations and impact assessments studies and projects
Supports process sub-teams throughout the phases of technology transfer (TT)
Serves as SME to support TT stage gate reviews on incoming processes and manufacturing readiness (e.g. acceptable process material evaluations risk assessments mitigation and robust supporting data for the proposed changes)
Provides comprehensive written manufacturing reports summarizing investigations studies and projects
Supports generation of sampling plans for process validation reports (PVRs) and investigations
As technical SME leads and supports generation of master plans contamination control strategy extractable and leachable assessment and other site procedures or policies
Collaborates with the Manufacturing department to support commercial and clinical manufacturing campaigns investigate materials issues and implement necessary changes
Leads continuous improvement projects in partnership with Manufacturing Quality Engineering and global teams when applicable to improve manufacturability reliability yield and cost
Deploys and maintains Large Scale Business Unit (LSBU) strategic roadmap for continuous and breakthrough improvements and associated requirements
Other duties as assigned

Minimum Requirements:

Bachelors degree in Engineering Life Science or Chemical Engineering with 8 years of relevant experience; or
Masters degree in in Engineering Life Science or Chemical Engineering with 6 years of relevant experience; or
PhD with 3 years of relevant experience
Experience working in Good Manufacturing Practices
(GMP) environment

Preferred Requirements:

Prior drug substance or manufacturing experienceincluding expertise in process validation transfer and
commercialization and manufacturing support and troubleshooting
Experience supporting or writing portions of regulatory filings and supporting regulatory audits
Direct experience with new product launches and validation of
process
Experience managing global or multi-site validation programs

Physical and Work Environment Requirements:

Ability to discern audible cues

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:

Senior IC

Position OverviewThe Sr Engineer or Scientist of Material Science 1 manages the design and development of new single-use consumables in conjunction with our manufacturing teams. This role manages the leachable and extractables program including organizing testing and creating a data library based on...