- Perform QC analytical testing for GMP in-process, release and stability testing as needed:
- PH Conductivity & qPCR required
- HPLC, RP-HPLC, SEC, Agarose Gel Electrophoresis, UPLC, CE, IEF, Protein Purity Assay, Peptide Mapping, DNA Sequencing and/or UV/Vis Spectrometry preferred
- Residual Analysis and/or Surfactant Analysis
- Osmolality testing
- Executes technical transfer, qualification and validation protocols as needed.
- 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)
- Assisting and initiating closure of deviations, CAPAs and Change Controls
- Reviewing Methods for accuracy: HPLC, Chromatography (Ion Exchange, SEC, RP-HPLC, Residual Analytes)
- Assist with technical training of less experienced members of the team.
- Facilitate the maintenance and repair of equipment
- 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
- Provides OOS investigational support as needed.
- Provides QC support for the sites Environmental Monitoring program and raw material analysis.
- Perform other duties as assigned.
Required Skills & Abilities:
- 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 required.
- Excellent written and oral communication skills.
- Excellent 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:
- 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.
- Ability to lift up to 30 pounds on occasion.
- Attendance is mandatory.
- Master’s degree in Chemistry, Biochemistry or related degree, with 1 year hands on laboratory experience; OR
- Bachelor’s degree in Chemistry, Biochemistry or related degree with 2 years hands on laboratory experience; OR
- Associates degree in Chemistry, Biochemistry or related degree with 4 years of hands on laboratory experience,
- AND 2 years’ industry experience in a GMP / GxP or a comparable federally regulated environment.
Familiar with monoclonal antibody testing methodology. Experience in assay troubleshooting and problem solving.
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.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.