Scientist 2 (LC/CE)

FUJIFILM; Morrisville (NC); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) plan with company contributions

Paid vacation and holidays

Life/work balance programs

Job summary

FUJIFILM Biotechnologies is seeking a Scientist II in the Analytical Development Lab to develop and transfer analytical methods for protein therapeutics using CE, U/HPLC, and standard physiochemical techniques. The role requires SME-level knowledge in Empower, CE, or U/HPLC.

The successful candidate will collaborate across Analytical Development, Process Development, Manufacturing, and Quality to ensure project success and regulatory compliance.

Qualifications

• Master's or Bachelor's with relevant experience in analytical development.
• Experience with method qualification, transfer, and validation is preferred.
• Familiarity with regulatory expectations for analytical method lifecycle management is a plus.

Responsibilities

• Develop, optimize, and transfer analytical methods for protein therapeutics by U/HPLC, CE, and standard physiochemical techniques.
• Support method qualifications, transfers, validations and process development.
• Design, execute, and interpret analyses to support development programs and technology transfers.
• Analyze datasets and communicate scientifically sound conclusions to teams.

Skills

Analytical method development

Capillary Electrophoresis

U/HPLC

Empower data analysis

Transfer & validation

Education

Master's degree in a relevant scientific discipline

Bachelor's degree in a relevant scientific discipline

Tools

Empower

Job description

Position Overview

As a Scientist II in the Analytical Development Lab, this role will be to develop +/- transfer of Capillary Electrophoresis (CE: CE-SDS, icIEF), U/HPLC and basic physiochemical methods (e.g. IEX, RP, SEC, Affinity, HIC) for protein based therapeutics. The role will be a subject matter expert in Empower, CE or H/UPLC.

Company Overview

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

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:

• Develop, optimize, and transfer analytical methods for characterization and release testing of protein therapeutics by U/HPLC, CE and standard physiochemical methods

• Support method qualifications, transfers, validations and process development support

• Design, execute, and interpret analytical studies to support development programs and technology transfers.

• Analyze complex datasets and communicate scientifically sound conclusions to project teams and stakeholders.

• Author technical documentation including protocols, reports, laboratory records.

• Collaborate with colleagues across Analytical Development, Process Development, Manufacturing, and Quality functions to ensure project success.

• Contribute to or lead analytical workstreams or support multiple projects in a fast-paced development environment.

• Develop and maintain Empower reports, processing methods, and custom fields to support analytical workflows.
• Served as a technical expert in CE, U/HPLC or Empower custom fields
• Development +/- transfer of Capillary Electrophoresis (CE: CE-SDS, icIEF) and U/HPLC methods (e.g. IEX, RP, SEC, Affinity, HIC) for protein based therapeutics

Basic Qualifications:

• Master's degree in a relevant scientific discipline with 3+ years of relevant experience, OR Bachelor's degree in a relevant scientific discipline with 7+ years of relevant experience.

Preferred Qualifications:

• Experience with analytical method qualification, transfer, and validation.

• Experience supporting method transfer into Quality Control laboratories.

• Familiarity with regulatory expectations for analytical method lifecycle management.

Physical Demands:

• The position requires essential physical abilities, including but not limited to typing, standing, stooping, crouching, reaching, pushing, pulling, lifting, fingering, grasping, feeling, talking, hearing, seeing repetitive motions, and the ability to move around in designated areas. Additionally, this individual may need to exert physical effort such as lifting objects up to 50 pounds occasionally, and/or up to 20 pounds of force frequently, and/or up 10 pounds of force constantly to move objects.

Visual Acuity:

• The individual in this position should have the visual acuity required to perform activities such as preparing and analyzing data and figures; viewing a computer terminal engaging in extensive reading, using measurement devices, and/or assembly or fabrication at distances close to the eyes.

Environmental Conditions:

• The individual in this position works in an indoor environment with controlled temperatures, avoiding extreme heat or cold. Some areas may be prone to loud noises requiring the use of earplugs. This role involves exposure to proteins, caustic agents, reagents, biohazardous products, and possible needle sticks. Additionally, the person in this role may be exposed to pungent smells, irritants, and/or aerosols that could affect the airways and the skin.

Benefits:

Our programs are designed to focus on maintainingand enhancing all pillars of health with arobust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading401(k) savings plan, insurance coverage, employee assistanceprograms and various wellness incentives. We support life-work balance withpaid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

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 ([e-mail]).