- Work in BSL-2 and BSL-1 environments.
- Develop or adapt and implement bioanalytical assays e.g. HPLC, ELISA, flow cytometry, bioassays.
- Interface with external clients to understand their needs and effectively communicate these needs to internal departments. Ability to work with team members and client to trouble-shoot and solve complex problems to keep the client satisfied with end results.
- Clearly articulate in presentations to senior management and/or clients regarding problems, updates, and/or results.
- Transfer analytical methods from other collaborators/clients.
- Optimize assays as needed for implementation in a QC environment and train QC analysts in method performance.
- Write method qualification and validation protocols and reports.
- Maintain a laboratory notebook according to company guidelines.
- Summarize results and generate reports.
- Maintain analytical instrumentation as needed and interface with external vendors for instrument installation and operation qualifications.
- Train other analytical personnel.
- Stay abreast of new technologies in the field.
- Expand expertise to other types of assays.
- All other duties as may be assigned.
Required Skills & Abilities:
- Experience with analytical instrumentation such as analytical chromatography.
- Proficiency in assay development.
- Experience with assay qualification and validation.
- Ability to perform proteins assays, SDS-PAGE, Western blotting, HPLC, CE, cell-based assays, immunoassays and/or molecular assays such as q-PCR.
- Ability to work on multiple projects.
- Knowledge of statistics for analytical chemistry.
- Familiarity with Design of Experiments (DOE) statistical tools.
- Ability to formally present problems, updates, and/or results.
- Significant knowledge of bioanalytical techniques demonstrated through industry or academic performance.
- Ability to clearly communicate in writing and verbally to senior management and/or clients.
- Ability to write and perform detailed analytical procedures.
- Ability to train analytical personnel.
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 sitting, 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.
- Attendance is mandatory.
- D. in Chemistry, Biochemistry, Biotechnology, Food Science, Biological or Chemical Engineering or a related field with 4 years of demonstrated relevant experience.
- S. in Chemistry, Biochemistry, Biotechnology, Food Science, Biological or Chemical Engineering or a related field with 8 years of demonstrated relevant experience.
- Experience working in a GMP environment.
- Knowledge of protein expression platforms or protein purification techniques.
- Tissue culture experience.
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.