- Assist in the development, optimization, and scale-up of cell- and virus/viral vector-based processes including cell banking, adherent and suspension cell culture, cell counting and metabolite analysis.
- Assist in setting up, operating, and troubleshooting single use stirred tank bioreactors up to 200L scale.
- Assist in maintaining and monitoring process development equipment.
- Operate development and pilot scale upstream equipment, including shake flasks, bench-scale stirred tank bioreactors, with emphasis on single-use equipment.
- Operate various centrifuge and cell/virus culture harvest equipment.
- Cross-train in Downstream PD and Virology and Analytical Development groups to gain knowledge and functional capability in these areas.
- Participate in evaluating assay performance characteristics and summarizing results.
- Participate in developing and carrying out experimental protocols.
- Maintain detailed laboratory notebooks.
- Perform all other duties as assigned.
Required Skills & Abilities:
- Excellent laboratory techniques.
- Strong proficiency with Microsoft Office applications.
- Familiarity with writing SOP’s and batch records.
- Understanding of cGMP procedures and protocols.
- Good self-discipline and attention to detail.
- Must have good planning, organizational, and time management skills; excellent oral and written communication skills; and be willing and able to interface with colleagues in many different roles and functions throughout the organization.
- Understanding of scale up and technology transfer from pilot plant to commercial scale.
- Knowledge of multiple cell culture protocols including both adherent and suspension cell growth technologies.
- Understanding of adherent and suspension cell culture lines.
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, pushing, pulling, reaching above shoulders and stretching.
- Hand-eye coordination and manual dexterity sufficient to operate office and laboratory equipment.
- Lift up to 25 pounds frequently and up to 50 pounds occasionally.
- Attendance is mandatory.
- Master’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with 1 year of relevant experience; OR
- Bachelor’s Degree preferably in Chemistry, Biology, Life Sciences or related field, with 2 years’ of relevant experience.
- Experience in pharmaceutical or biotechnology industry.
Experience working in a cGMP facility.
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.