Summary: The Quality Control Chemist II will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. This critical role will involve on-site training at the FujiFilm Biotechnologies Diosynth (FDBU) laboratory in Morrisville, NC. Following the analytical training on selected methods in Morrisville, the candidate will be staffed permanently at the Texas facility as a Subject Matter Expert (SME) in the methods trained on and transferred at FDBU.
- Participate in training the QC Chemistry Staff at FDBT in the established release methods.
- Perform QC analytical testing for GMP release and stability testing as needed.
- Executes tech transfer, qualification and validation protocols as needed.
- Contributes to writing and revising Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
- Support the establishment of a system for managing test samples, reagents and reference standards.
- Reports excursion/out of specifications results to the QC Departmental Manager.
- Provides OOS investigational support as needed.
- Perform other duties as assigned.
Required Skills & Abilities:
- Proficient in UPLC, HPLC, UV spectroscopy, CE, and IEF methodologies.
- Ability to analyze raw data, assess assay and system suitability criteria.
- Perform as a SME in the designated methods transferred into FDBT from FDBU.
- 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.
- Good attention to detail.
- Good computer skills.
- Demonstrated written and oral communication skills.
- Strong organization and analytical skills.
Working Conditions & 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:
- Willingness to travel to FDBU location in Morrisville, NC for an extended period of time.
- Permanent relocation to FDBT location in College Station, TX
- Experience prolonged standing, some bending, stooping, and stretching.
- Use hand-eye 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.
- Attendance is mandatory.
- Master’s degree preferably in Chemistry or Biochemistry with 1 year hands on laboratory experience; OR
- Bachelor’s degree preferably in Chemistry or Biochemistry with 2 years hands on laboratory experience.
- Familiar with monoclonal antibody testing methodology. Experience in assay troubleshooting and problem solving. Familiar with GMP documentation and Quality Systems.
- GMP / GLP experience