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Quality Control Chemist II
2 months ago
Position Overview:
At FUJIFILM Corporation, we recognize the significance of our work and are eager to welcome skilled professionals to our team. As we expand our operations and enhance our capabilities, we seek dedicated individuals who are driven by a mission to make a meaningful impact in the lives of others. Join us in the pursuit of developing groundbreaking vaccines, cures, and gene therapies in collaboration with leading biopharmaceutical companies worldwide. We take pride in fostering a vibrant culture that inspires passion, energy, and determination—what we refer to as Genki.
Role Summary:
The Quality Control Chemist II will operate with a degree of autonomy, contributing to the Technology Transfer of established methodologies into the FUJIFILM Biotechnologies Diosynth Texas Quality Control Laboratory. Following the transfer activities, the incumbent will be tasked with conducting release and stability assessments utilizing established analytical techniques.
Reporting Structure:
Reports to the QC Manager, Chemistry.
Key Responsibilities:
- Conduct QC analytical evaluations for GMP release and stability testing as required.
- Perform pH Conductivity & qPCR testing as essential.
- Utilize HPLC, Agarose Gel Electrophoresis, UPLC, CE, IEF, and/or UV/Vis Spectrometry as preferred methods.
- Execute osmolality assessments.
- Carry out SDS Page & Western Blot analyses.
- Implement technical transfer, qualification, and validation protocols as necessary.
- Draft and update Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
- Develop and maintain a system for managing test samples, reagents, and reference standards.
- Report any excursions or out-of-specification results to the QC Departmental Supervisor/Manager.
- Provide investigational support for out-of-specification results as needed.
- Ensure the laboratory environment is organized, clean, and adequately supplied.
- Perform additional duties as assigned.
Qualifications:
- Bachelor's degree in Chemistry, Biochemistry, or a related field with a minimum of 2 years of practical laboratory experience; OR
- Associate's degree in Chemistry, Biochemistry, or a related field with at least 3 years of practical laboratory experience; AND
- 1+ year of experience in a GMP/GxP or a comparable federally regulated setting.
- Familiarity with monoclonal antibody testing methodologies.
- Experience in troubleshooting assays and problem-solving.
- Ability to analyze raw data and evaluate assay and system suitability criteria.
- Act as a Subject Matter Expert (SME) in the designated methods transferred into the laboratory.
- Adhere to safety protocols outlined in the Chemical Hygiene Plan.
- Utilize Material Safety Data Sheets (MSDS) to assess chemical hazards, spill response procedures, and personal protective equipment (PPE) requirements.
- Demonstrate exceptional attention to detail.
- Proficiency in computer applications is required.
- Exhibit excellent written and verbal communication skills.
- Possess strong organizational and analytical abilities.
- Serve as a role model for the company's core values of trust, customer satisfaction, Gemba, and Genki.
Physical Requirements:
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. While executing the responsibilities of this role, the employee is regularly required to:
- Engage in prolonged standing, with some bending, stooping, and stretching.
- Utilize hand-eye coordination and manual dexterity sufficient to operate office equipment.
- Maintain the ability to sit for extended periods while working on a computer.
- Potentially encounter exposure to hazardous chemicals, gases, fumes, odors, mists, dusts, and other hazardous materials.
- Wear personal protective equipment including safety glasses, lab coats, and gloves.
- Lift up to 30 pounds occasionally.
- Maintain consistent attendance.
Join FUJIFILM Corporation as we advance the future of medicine, empowering our employees to pursue the extraordinary and continually enhance their potential. We are a company of ambitious goal seekers, motivated by a fundamental desire to improve ourselves, our families, our workplace, our organization, our community, and the world at large.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
