QC Lead, Chemistry - Second Shift

Fujifilm

Posted on : 20-05-2025

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1 Vacancy

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Job Location

College Station, TX - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 20-05-2025

Job Description

Position Overview

The Quality Control Chemist Lead with limited supervision will be responsible for mentoring the team on technical aspects of performing inprocess release and stability testing using the established analytical methods. This position is a pivotal role to either a technical career path as a Chemist IV or a managerial career path as a Lead for the team and a successful individual in this role will lead the team regardless of the career path they decide to pursue.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies Texas has never been more importantand we are looking for passionate missiondriven people like you who want to make a real difference in peoples lives.

From developing the next vaccine to advancing cell and gene therapies we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If youre ready to help transform the future of medicine join FUJIFILM Diosynth Biotechnologies. We offer a flexible work environment and were proud to cultivate a culture that will fuel your passion energy and drivewhat we call Genki.

Our stateoftheart biomanufacturing facility is located in in College Station Texas which combines a smalltown feel with vibrant culture topnotch schools and close proximity to big city life. Nestled between major hubs its a dynamic location that blends convenience with innovation.

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

Reports to QC Manager Chemistry

Work Location College Station TX

Primary Responsibilities:

Lead QC analytical testing for GMP inprocess release and stability testing as needed.
- PH Conductivity & qPCR.
- HPLC RPHPLC SEC Agarose Gel Electrophoresis UPLC CE IEF Protein Purity Assay Peptide Mapping DNA Sequencing and/or UV/Vis Spectrometry.
- Residual Analysis and/or Surfactant Analysis
- Osmolality testing
- Western Blot
Executes technical transfer qualification and validation protocols as needed.
Leads evaluation of equipment for use.
Leads IQOQ evaluation.
Help to maintain safety and orderliness of the lab; apply knowledge of cGMPs and GLPs on a daily basis.
Technical Writing to include:
- Writes and revises Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
- Qualification protocols.
- Transfer Protocols.
- Creating manuals for processes/activities.
- Sample plans (support & edit).
- Lead the initiation and closure of deviations CAPAs and Change Controls.
- Reviewing Methods for accuracy:
  - HPLC Chromatography (Ion Exchange SEC RPHPLC Residual Analytes).
Lead technical training for less experienced members of the team.
Facilitate the maintenance and repair of equipment.
Facilitate the communication between various different departments.
Develop and support a system for managing test samples reagents and reference standards.
Reviews data obtained for compliance to specifications and reports excursion/out of specifications.
Leads OOS investigations and support as needed.
Leads QC support for the sites Environmental Monitoring program and raw material analysis.
Ensure lab is maintained (organized clean properly supplied).
Perform other duties as assigned.

Qualifications:

Bachelors degree preferably in Chemistry or Biochemistry with 4 years of handson laboratory experience.
Associates degree preferably in Chemistry or Biochemistry with 6 years of handson laboratory experience.
4 years industry experience in a GMP/GxP or a comparable federally regulated environment required.
Familiar with monoclonal antibody testing methodology. Experience in assay troubleshooting and problem solving.
Ability to analyze raw data assess assay and system suitability criteria understand process from beginning to end and explain process.
Excellent communication skills.
Ability to work independently or in a team.
Perform as a SME in the designated methods transferred into FDBT.
Previous pipetting experience.
Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
Utilize MSDS sheets to properly assess chemical hazards spill response procedures and PPE requirements if indicated.
Excellent attention to detail.
Computer proficiency.
Excellent written and oral communication skills.
Excellent organization and analytical skills.
Role model for company core values of trust delighting our customers Gemba and Genki.

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 the essential functions. While performing the duties of this job the employee is regularly required to:

Experience prolonged standing some bending stooping and stretching.
Use handeye coordination and manual dexterity sufficient to operate a keyboard photocopier telephone calculator and other office equipment is required.
Ability to sit for long periods to work on a computer.
Potential for exposure to hazardous chemicals gases fumes odors mists and dusts and other hazardous materials.
Ability to wear personal protective equipment including safety glasses lab coat and gloves.
Ability to lift up to 30 pounds on occasion.
Attendance is mandatory.

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 viaemail 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 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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ( or (979)).

Employment Type

Unclear

Company Industry

Department / Functional Area

Quality Control

Key Skills

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About Company

Fujifilm

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QC Lead, Chemistry - Second Shift

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Department / Functional Area

Key Skills

About Company

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