Summary: The Scientist I, under general supervision, will help FDBT to develop new methods to support clients and adapt client-specific methods to FDBT instrumentation as well as helping to qualify and/or validate them.
- Work in BSL-2 and BSL-1 environment.
- 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 troubleshoot and solve complex problems to keep the client satisfied and happy 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 SOP/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.
- Provide technical training to peers as needed.
- Stay abreast of new technologies in the field.
- Expand expertise to other types of assays.
- Ensure lab is maintained (organized, clean, properly supplied).
- All other duties as may be assigned.
Required Skills & Abilities:
- Experience with analytical instrumentation such as analytical chromatography/ELISA.
- Experience in assay development.
- Ability to work professionally as part of a team and independently.
- Knowledge of assay qualification and validation.
- Ability to perform one of more of the following assays such as ELISA, SDS-PAGE, Western blotting, HPLC, CE, cell-based assays, DD-PCR, immunoassays and/or molecular assays such as q-PCR.
- Ability to work on multiple projects.
- Experience working in a GMP environment is considered a plus.
- Knowledge of statistics for analytical chemistry.
- Ability to formally present problems, updates, and/or results.
- 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 technical aspects of the job to 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.
- 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.
- Use hand-eye coordination and manual dexterity sufficient to operate a manual pipets and other analytical equipment is required.
- Ability to wear personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in most areas associated with this position.
- May be required to lift up to 25 pounds frequently and up to 50 pounds on occasion.
- Attendance is mandatory.
- Ph.D. in Chemistry, Biochemistry, Biotechnology, Food Science, Biological or Chemical Engineering or a related field; OR.
- M.S. in Chemistry, Biochemistry, Biotechnology, Food Science, Biological or Chemical Engineering or a related field with four (4) years of demonstrated relevant experience.
- Some experience in a GMP/GLP regulated environment.
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.